Regulatory News

The latest regulatory news, consultation documents, and adopted guidelines and legislation, mainly from the European Commission, the European Medicines Agency and the Food and Drug Administration.

Veterinary pharmaceuticals in groundwater
The European Medicines Agency have published: Scientific guideline: Draft guideline on assessing the toxicological risk to human health and groundwater communities from veterinary pharmaceuticals in groundwater, draft: consultation open.

The guideline complements existing guidelines such as the CVMP guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL 6 and GL 38. These guidelines provide a methodology for risk assessment of veterinary medicines, but for groundwater they only provide a methodology for exposure assessment. More information is available on the EMA’s website.

Consultation Deadline: 31st August, 2017

DNA reactive (mutagenic) impurities in veterinary medicinal products
The European Medicines Agency have published: Scientific guideline: Draft guideline on assessment and control of DNA reactive (mutagenic) impurities in veterinary medicinal products, draft: consultation open.

The purpose of this guideline is to provide a practical framework that is applicable to the identification, categorization, qualification, and control of these mutagenic impurities to limit potential carcinogenic risk. This guideline is intended to complement VICH GL10 and VICH GL11 (Note 1).
This guideline emphasizes considerations of both safety and quality risk management in establishing levels of mutagenic impurities that are expected to pose negligible carcinogenic risk. It outlines recommendations for assessment and control of mutagenic impurities that remain or are reasonably expected to remain in final drug substance or VMP. More information is available on the EMA’s website.

Consultation Deadline: 31st August, 2017

Surveillance of Eudravigilance Veterinary (EVVet) data
The European Medicines Agency have published: Scientific guideline: Superseding version – Draft revised recommendation for the basic surveillance of Eudravigilance Veterinary (EVVet) data for centrally authorised products (CAPs), draft: consultation open.

This is the first revision of the recommendation for the basic surveillance of Eudravigilance Veterinary (EVVet) data. The main aim of the revision is to improve the overall pharmacovigilance surveillance process, where possible, by integrating periodic safety update report (PSUR) evaluation and signal detection processes based on EVVet data and using a risk-based principles. More information is available on the EMA’s website.

Consultation Deadline: 31st August, 2017

Residue studies in honey
The European Medicines Agency have published: Scientific guideline: Draft VICH GL56 Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing species: study design recommendations for residue studies in honey for establishing MRLs and withdrawal periods, draft: consultation open.

The objective of this guidance is to provide study design recommendations which will facilitate the universal acceptance of the generated residue depletion data to fulfill the national/regional requirements in order to establish appropriate Maximum Residue Limits (MRLs) or other safe limits in honey following the treatment of honeybees with veterinary drug products, or to justify withdrawal periods in honey for registration purposes when an MRL already exists. More information is available on the EMA’s website.

Consultation Deadline: 31st July, 2017

Replication competent endogenous retrovirus RD114 in starting materials and final products of feline and canine vaccines
The European Medicines Agency have published: Regulatory and procedural guideline: CVMP Risk Management Strategy – Managing the risk of the potential presence of replication competent endogenous retrovirus RD114 in starting materials and final products of feline and canine vaccines.

The Committee for Veterinary medicinal products (CVMP) established an ad hoc expert group (AHEG) in 2015 to assist in the development of a risk management strategy for the potential presence of replication competent RD114 in feline and canine vaccines. The AHEG was requested to reflect on any proposed risk mitigation measures and perform an impact assessment on the effect of these measures upon the availability of feline and canine vaccines. The risk management strategy has been elaborated in the light of newly available regulatory guidance and takes account of the most recent scientific data provided by manufacturers of canine and feline vaccines and in context with published literature. More information is available on the EMA’s website.

Oral explanations at CVMP
The European Medicines Agency have published: Regulatory and procedural guideline: Guidance to applicants / marketing authorisation holders on oral explanations at CVMP.

This document is intended to provide practical guidance to companies invited to give oral explanations to the Committee for Medicinal Products for Veterinary Use (CVMP); however, the same principles will usually apply for oral explanations at CVMP Working Parties and other CVMP Advisory Group meetings (irrespective of the type of application / procedure under discussion). More information is available on the EMA’s website.

Q11 Development and Manufacture of Drug Substances
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled “Q11 Development and Manufacture of Drug Substances—Questions and Answers (regarding the selection and justification of starting materials).”

The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance consists of questions and answers that were developed to clarify the principles for selecting starting materials described in the ICH guidance “Q11 Development and Manufacture of Drug Substances”. The draft guidance is intended to provide additional clarification and to promote convergence on the considerations for the selection and justification of starting materials. The question-and-answer (Q&A) draft guidance focuses on chemical entity drug substances, and provides recommendation on the information that should be provided in marketing authorization applications and/or Master Files to justify the starting materials. More information is available on the Federal Register’s website.

Consultation Deadline: 23rd March, 2017

Supplementary protection certificates and patent research exemptions for sectors whose products are subject to regulated market authorisations
The European Commission has published a roadmap for the Inception Impact Assessment “Optimising the Internal Market’s industrial property legal framework relating to supplementary protection certificates (SPC) and patent research exemptions for sectors whose products are subject to regulated market authorisations.”

More information is available on the Commission’s website.

EMA revised policy on access to documents
The European Medicines Agency (EMA) has launched a public consultation on the proposed revision to its policy on access to documents.

The policy describes the rules EMA applies to grant access to the documents that it holds, in accordance with Regulation (EC) No 1049/2001External link icon, which gives citizens a right to access EU documents. The revision is based on EMA’s experience with the original policy introduced in 2010. The new version extends the scope of the policy to include explicitly corporate documents and takes into account the Agency’s proactive approach to transparency that has led to the publication of many more documents on the EMA website since 2010. More information is available on the EMA’s website.

Consultation Deadline: 18th May, 2017

Quality requirements of medicinal products containing a device component
The European Medicines Agency have published: Scientific guideline: Concept paper on developing a guideline on quality requirements of medicinal products containing a device component for delivery or use of the medicinal product, draft: consultation open.

This concept paper addresses the need for development of a guideline on dossier requirements for medical devices that are supplied along with medicinal products where a device is necessary for administration or localisation (site-specific delivery) of the medicinal product. More information is available on the EMA’s website.

Consultation Deadline: 16th May, 2017

Section 5.1 of the summary of product characteristics on pharmacodynamic properties for pharmaceutical products
The European Medicines Agency have published: Regulatory and procedural guideline: Question and answer on the information contained within section 5.1 of the summary of product characteristics on pharmacodynamic properties for pharmaceutical products.

This question and answer was developed to aid the writing or update of section 5.1 of the summary of product characteristics (SPC). These principles were agreed by the Committee for Medicinal Products for Veterinary Use (CVMP) and the Veterinary Coordination Group for MRP/DCP (CMDv) at their respective meetings in January 2017. More information is available on the EMA’s website.

Requirements for transactions with first responders
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic Act — Compliance Policy.”

This guidance addresses the compliance of dispensers that engage in transactions with first responders and the compliance of first responders with the provisions in section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1) related to the exchange of product tracing information (i.e., transaction information, transaction history, and transaction statements) and verification. This guidance also addresses the compliance of trading partners that engage in transactions with first responders with the requirement for conducting business only with authorized trading partners. More information is available on the FDA’s website.

Chemistry of active substances (veterinary)
The European Medicines Agency have published: Scientific guideline: Draft guideline on the chemistry of active substances (veterinary), draft: consultation open.

The purpose of this guideline is to set out the type of information required for the manufacture and control of active substances (existing or new chemical entities) used in a veterinary medicinal product. More information is available on the EMA’s website.

Consultation Deadline: 13th August, 2017

Dear Health Care Provider Letters
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry and FDA staff entitled “Dear Health Care Provider Letters: Improving Communication of Important Safety Information.”

DHCP letters are correspondence ― often in the form of a mass mailing from the manufacturer or distributor of a human drug or biologic or from FDA ― intended to alert physicians and other health care providers about important new or updated information regarding a human drug or biologic. This guidance provides recommendations on (1) when to issue a DHCP letter, (2) the types of information to include in a DHCP letter, (3) how to organize that information so that it is communicated effectively to health care providers, and (4) formatting techniques to make the information more accessible. More information is available on the FDA’s website.

The need for non-human primates in biomedical research, production and testing of products and devices
The European Commission and its Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) have launched a public consultation on the preliminary Opinion ‘The need for non-human primates in biomedical research, production and testing of products and devices’.

On the Commission’s request, the SCHEER has reviewed recent evidence to update the 2009 Opinion on the need for non-human primates in biomedical research. The Opinion concludes that the current state of knowledge does not permit to propose a timetable for phasing-out the use of non-human primates in Europe and provides recommendations on how to advance 3Rs for NHP use, such as alternative methods, training, improvement of techniques and protocols, sharing of knowledge, removal of barriers and research needs. More information is available on the Commission’s website.

Consultation Deadline: 26th March, 2017

European Surveillance of Veterinary Antimicrobial Consumption
The European Medicines Agency have published: Regulatory and procedural guideline: European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) Vision and Strategy 2016-2020, adopted.

This document seeks to define the vision and strategy for the ESVAC activity for the period 2016-2020. Once finalised, this strategy will be used as the basis for the successor to the current ESVAC project plan 2013-2016 (EMA/42322/2013). The EU Medicines Agencies Network Strategy to 2020 (EMA/MB/151414/2015) includes support for ESVAC as an important element within Theme 2, Objective 4 ‘Focus on key public and animal health priorities including antimicrobial resistance’. Activities within the Network Strategy, including ESVAC, will be delivered through inclusion within the multi-annual work plans of both the Agency and the Heads of Medicines Agencies (HMA). More information is available on the EMA’s website.

Support for applications on Article 58
The European Medicines Agency have published: Regulatory and procedural guideline: Support for applications on Article 58.

Applicants have the opportunity for certain medicinal products intended exclusively for markets outside the European Union to apply for a scientific opinion from the European Medicines Agency (EMA), in cooperation with the World Health Organization (WHO). To this effect, the Agency supports the medicine development and registration processes from an early stage and offers regulatory mechanisms to help candidates for Article 58 applications as early as possible. Companies developing such medicinal products are invited to liaise with the EMA for their products to make full use of these opportunities. More information is available on the EMA’s website.

One Health Action Plan to support Member States in the fights against Antimicrobial Resistance (AMR)
The European Commission has launched an Open Public Consultation on possible activities under a ‘Commission Communication on a One Health Action Plan to support Member States in the fights against Antimicrobial Resistance (AMR)’.

The European Commission’s 2011-2016 action plan against the rising threats of AMR was evaluated in 2016 concluding that the EU can bring added value in the fight against AMR, by: 1) supporting Member States and making the EU a best practice region on AMR; 2) boosting research, development and innovation against AMR; and 3) shaping the global agenda on AMR. The European Commission will launch by mid-2017 a ‘Commission communication on a One Health action plan to support Member States in the fight against antimicrobial resistance (AMR)’. The objective of this consultation is to collect the views and input of citizens, administrations, associations and other organisations for the currently ongoing process on proposals for the Commission communication. More information is available on the Commission’s website.

Consultation Deadline: 28th April, 2017

SmPC and Package Leaflet for nanocolloidal technetium (99mTc) albumin
The European Medicines Agency have published: Scientific guideline: Guideline on core SmPC and Package Leaflet for nanocolloidal technetium (99mTc) albumin – First version, adopted.

This guideline describes the information to be included in the Summary of Products Characteristics (SmPC) and Package Leaflet for nanocolloidal technetium (99mTc) albumin. More information is available on the EMA’s website.

Efficacy studies for intramammary products for use in cattle
The European Medicines Agency have published: Scientific guideline: Guideline on the conduct of efficacy studies for intramammary products for use in cattle, adopted.

This revised guideline is intended to provide guidance on the conduct of efficacy studies and their evaluation for veterinary medicinal products that are administered via the teat canal to cattle. It therefore addresses the treatment of clinical and subclinical mastitis during the lactation period, the treatment of subclinical mastitis at drying off, and the prevention of new intramammary infections during the dry period. The scope of the guideline has been extended in order to include recommendations on pre-clinical data, in addition to those on clinical field studies for the demonstration of efficacy. Moreover, information is included for generic intramammary products. More information is available on the EMA’s website.

Date for coming into effect: 1st August, 2017

Documents obtained or resulting from pharmacovigilance inspections
The European Medicines Agency have published: Regulatory and procedural guideline: Union guidance on record keeping and archiving of documents obtained or resulting from pharmacovigilance inspections, adopted.

The scope of this document is to provide high level principles for the record keeping and archiving of documents in relation to EU pharmacovigilance (PhV) inspections of marketing authorisation holders (MAHs) of medicinal products for human use carried out by the competent authorities of Member States of the European Union. More information is available on the EMA’s website.

Post-orphan medicinal product designation procedures
The European Medicines Agency have published: Regulatory and procedural guideline: Post-orphan medicinal product designation procedures: guidance for sponsors.

This guideline covers the information and procedures applicable to orphan designated products. More information is available on the EMA’s website.

Article 31 non-pharmacovigilance referrals
The European Medicines Agency have published: Regulatory and procedural guideline: Questions and answers on Article 31 non-pharmacovigilance referrals.

This guidance document addresses a number of questions which stakeholders, in particular the marketing authorisation holders (MAHs)/applicants, may have on an Article 31 non-pharmacovigilance referral procedure. It provides an overview of the European Medicines Agency’s (the Agency) practical and operational aspects with regards to the handling of Article 31 non-pharmacovigilance referral procedures. More information is available on the EMA’s website.

Medical product communications that are consistent with the FDA-required labeling
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Medical Product Communications That Are Consistent With the FDA-Required Labeling—Questions and Answers.”

This draft guidance provides information for manufacturers, packers, and distributors and their representatives (collectively “firms”) of drugs and medical devices for humans, including those that are licensed as biological products, and animal drugs (collectively “medical products”), about how FDA evaluates their medical product communications, including their promotional materials, that present information that is not contained in the FDA-required labeling for the product but that may be consistent with the FDA-required labeling for the product. The Agency is issuing this draft guidance to explain FDA’s current thinking on commonly asked questions regarding such communications in order to provide clarity for firms. More information is available on the Federal Register’s website.

Consultation Deadline: 19th April, 2017

Drug and device manufacturer communications with payors, formulary committees, and similar entities
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and review staff entitled “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities—Questions and Answers.”

This draft guidance provides information for manufacturers, packers, and distributors and their representatives (collectively “firms”) of drugs and medical devices for humans, including those that are licensed as biological products, and animal drugs (collectively “medical products”), about how FDA evaluates their medical product communications, including their promotional materials, that present information that is not contained in the FDA-required labeling for the product but that may be consistent with the FDA-required labeling for the product. The Agency is issuing this draft guidance to explain FDA’s current thinking on commonly asked questions regarding such communications in order to provide clarity for firms. More information is available on the Federal Register’s website.

Consultation Deadline: 19th April, 2017

2016 Medical Gas Container-Closure Rule
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (small entity compliance guide) entitled “2016 Medical Gas Container-Closure Rule Questions and Answers.”

This guidance is intended to help small businesses better understand and comply with recently issued regulations on current good manufacturing practice (CGMP) and labeling for medical gases. More information is available on the FDA’s website.

Demonstrating interchangeability with a reference product
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Considerations in Demonstrating Interchangeability With a Reference Product.”

This guidance is intended to assist sponsors in demonstrating that a proposed therapeutic protein product (proposed interchangeable product or proposed product) is interchangeable with a reference product for the purposes of submitting a marketing application or supplement under the Public Health Service Act (PHS Act). This guidance is one in a series of guidances that FDA has developed to implement the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). More information is available on the Federal Register’s website.

Consultation Deadline: 20th March, 2017

Abuse potential of drugs
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled “Assessment of Abuse Potential of Drugs.”

This guidance is intended to assist sponsors of investigational new drugs and applicants for approval of a new drug in evaluating whether their new drug product has abuse potential. Specifically, this guidance provides recommendations for assessing the abuse potential of central nervous system (CNS)-active new drugs. Drug products with abuse potential generally contain drug substances that are active within the CNS and produce psychoactive effects such as euphoria and hallucinations. Thus, if a drug substance is CNS-active, the new drug product containing that drug substance will likely need to undergo a thorough assessment of its abuse potential and may be subject to control under the Controlled Substances Act (CSA). This guidance finalizes the draft guidance of the same name issued on January 27, 2010. More information is available on the Federal Register’s website.

Drug-device combination products submitted in an ANDA
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA.”

This draft guidance is intended to assist potential applicants who plan to develop and submit an abbreviated new drug application (ANDA) to seek approval of a generic combination product that includes both a drug constituent part and a delivery device constituent part. More information is available on the Federal Register’s website.

Consultation Deadline: 20th March, 2017

Referencing approved drug products in ANDA submissions
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Referencing Approved Drug Products in ANDA Submissions.”

Any person is permitted to submit an abbreviated new drug application (ANDA) in order to seek approval to market a generic version of a previously approved drug product. The purpose of this guidance is to provide information to potential applicants on how to identify a reference listed drug (RLD), reference standard, and the basis of submission in an ANDA submission. More information is available on the Federal Register’s website.

Consultation Deadline: 20th March, 2017

Good Clinical Practice (GCP) Renovation
ICH is inviting public review and comment on a reflection paper on Good Clinical Practice (GCP) “Renovation”, which contains the ICH proposal for further modernization of the ICH Guidelines related to clinical trial design, planning, management, and conduct.

The scope of the proposed renovation includes the current E8 General Considerations for Clinical Trials and further revision to the E6 Guideline for Good Clinical Practice, which is already undergoing modernization with the recent production of ICH E6(R2). More information is available on the ICH website.

Consultation Deadline: 11th March, 2017

Emergency use authorization of medical products
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry and other stakeholders entitled “Emergency Use Authorization of Medical Products and Related Authorities.”

The purpose of this guidance is to explain FDA’s current thinking on the authorization of the emergency use of certain medical products under certain sections of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended or added by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA). The provisions in PAHPRA include key legal authorities to sustain and strengthen national preparedness for public health, military, and domestic emergencies involving chemical, biological, radiological, and nuclear (CBRN) agents, including emerging infectious disease threats. More information is available on the Federal Register’s website.

Repackaging of certain human drug products by pharmacies and outsourcing facilities
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a final guidance for industry entitled “Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities.”

This guidance describes the conditions under which FDA does not intend to take action for violations of certain provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), when a State-licensed pharmacy, a Federal facility, or an outsourcing facility repackages certain human drug products. More information is available on the Federal Register’s website.

180-day exclusivity
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “180-Day Exclusivity: Questions and Answers.”

This draft guidance is intended to address questions that have been raised about the provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that relate to generic drug exclusivity, which commonly is known as “180-day exclusivity” for generic drug products. As a general matter, FDA has implemented these statutory provisions within the context of application-specific decisions. Some FDA decisions have been made publicly available (e.g., in FDA citizen petition responses and documents released in litigation). FDA believes that a guidance for industry that provides answers to commonly asked questions about 180-day exclusivity would enhance transparency and facilitate the development, approval, and timely marketing of generic drug products. FDA intends to update this guidance to include additional questions and answers as appropriate. More information is available on the Federal Register’s website.

Consultation Deadline: 14th March, 2017

Multiple endpoints in clinical trials
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Multiple Endpoints in Clinical Trials.”

This draft guidance provides sponsors and review staff with the Agency’s thinking about the problems posed by multiple endpoints in the analysis and interpretation of study results and how these problems can be managed in clinical trials for human drugs, including drugs subject to licensing as biological products. Most clinical trials performed in drug development contain multiple endpoints to assess the effects of the drug and to document the ability of the drug to favorably affect one or more disease characteristics. The purpose of this guidance is to describe various strategies for grouping and ordering endpoints for analysis and applying some well-recognized statistical methods for managing multiplicity within a study to control the chance of making erroneous conclusions about a drug’s effects. More information is available on the Federal Register’s website.

Consultation Deadline: 14th March, 2017

Mixing, diluting, or repackaging biological products outside the scope of an approved biologics license application
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a revised draft guidance for industry entitled “Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application.”

This revised draft guidance describes the conditions under which FDA does not intend to take action against a State-licensed pharmacy, a Federal facility, or an outsourcing facility that mixes, dilutes, or repackages certain biological products outside the scope of an approved biologics license application (BLA). It also describes the conditions under which FDA does not intend to take action when a State-licensed pharmacy, a Federal facility, an outsourcing facility, or a physician prepares prescription sets of allergenic extracts for subcutaneous immunotherapy. This revised draft guidance for industry replaces the draft guidance for industry of the same title issued in February 2015. More information is available on the Federal Register’s website.

Consultation Deadline: 14th March, 2017

How to prepare a pre-request for designation
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “How to Prepare a Pre-Request for Designation (Pre-RFD).”

The purpose of this guidance is to explain the Pre-RFD process at the FDA Office of Combination Products (OCP), describe and help a sponsor understand the type of information that the sponsor should include in a Pre-RFD, and assist sponsors in obtaining a preliminary assessment from FDA through the Pre-RFD process. The Pre-RFD process is available to provide informal, non-binding feedback regarding the regulatory identity or classification of a human medical product as a drug, device, biological product, or combination product. In addition, this informal process provides information about a non-combination or combination product’s assignment to the appropriate Agency Center (Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), or Center for Biologics Evaluation and Research (CBER)) for premarket review and regulation. This draft guidance is not final nor is it in effect at this time. More information is available on the Federal Register’s website.

Consultation Deadline: 14th March, 2017

Current Good Manufacturing Practice requirements for combination products
The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry and FDA staff entitled “Current Good Manufacturing Practice Requirements for Combination Products.”

The guidance describes and explains the document on current good manufacturing practice (CGMP) requirements for combination products, which published in the Federal Register of January 22, 2013, and includes general considerations for CGMP compliance as well as analysis of hypothetical scenarios. More information is available on the Federal Register’s website.

Recommended warning for OTC acetaminophen-containing drug products
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled “Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions.”

This guidance is intended to inform manufacturers, members of the medical and scientific community, and other interested persons that at this time FDA does not intend to take action against the marketing of single- and combination-ingredient, acetaminophen-containing, nonprescription (commonly referred to as over-the-counter (OTC)) drug products bearing a warning as described in the guidance alerting consumers that the use of acetaminophen may cause severe skin reactions. More information is available on the Federal Register’s website.

Recommended statement for OTC aspirin-containing drug products
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular Related Imagery.”

The guidance is intended to promote the safe use of nonprescription (also referred to as over-the-counter or OTC) aspirin drug products by encouraging drug manufacturers, packagers, and labelers marketing aspirin drug products with cardiovascular related imagery to include a statement that reminds consumers to talk to their health care provider before using aspirin for their heart. More information is available on the Federal Register’s website.

Consultation Deadline: 13th March, 2017

Annual reporting by wholesale distributors and 3PLs
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers.”

This draft addresses questions about and clarifies FDA’s expectations for annual reporting to FDA by prescription drug wholesale distributors (wholesale distributors) and third-party logistics providers (3PLs) as required under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended by the Drug Supply Chain Security Act (DSCSA). More information is available on the Federal Register’s website.

Consultation Deadline: 13th March, 2017

Manufacture of different medicinal products in shared facilities
The European Medicines Agency have published: Questions and answers on implementation of risk based prevention of cross contamination in production and ‘Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities’ (EMA/CHMP/CVMP/SWP/169430/2012), draft: consultation open.

More information is available on the EMA’s website.

Consultation Deadline: 30th April, 2017

In-use stability studies and associated labeling statements
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry #242 entitled “In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products.”

The purpose of in-use stability testing is to establish a period of time during which a multiple-dose drug product may be used while retaining acceptable quality specifications once the container is opened (e.g., after a container has been needle-punctured). This draft guidance reflects the Agency’s current thinking on how to formulate in-use statements, as well as how to design and carry out in-use stability studies to support these in-use statements, for multiple-dose injectable drug products intended for use in animals. This current thinking pertains to both generic drug products and pioneer drug products regardless of whether or not the pioneer reference listed new animal drug (RLNAD) currently has an in-use statement on the labeling. More information is available on the Federal Register’s website.

Consultation Deadline: 6th March, 2017

Metabolism and residue kinetics of veterinary drugs in food-producing species
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry #243 entitled “Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Study Design Recommendations for Residue Studies in Honey for Establishing MRLs and Withdrawal Periods” (VICH GL56)

This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document is intended to provide study design recommendations which will facilitate the universal acceptance of the generated residue depletion data to fulfill the national/regional requirements in order to establish appropriate Maximum Residue Limits (MRLs) or other safe limits in honey following the treatment of honeybees with veterinary drug products, or to justify withdrawal periods in honey for registration purposes when an MRL already exists. Use of veterinary drug products in honeybee production is considered as a minor use in minor species in most jurisdictions. More information is available on the Federal Register’s website.

Consultation Deadline: 6th March, 2017

Safety and residue data requirements for pharmaceutical veterinary medicinal products
The European Medicines Agency have published: Scientific guideline: Guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market, adopted.

In order to stimulate the research, development and innovation of new veterinary medicines intended for minor uses or minor species (MUMS)/limited market the CVMP developed guidelines on data requirements for MUMS/limited market veterinary medicinal products for quality, safety and efficacy for pharmaceuticals and a guideline for immunologicals. These guidelines are intended to reduce data requirements where possible for products classified as MUMS/limited market while still providing assurance of appropriate quality, safety and efficacy and complying with the legislation in place and leading to an overall positive benefit-risk balance for the product. These MUMS guidelines have now been reviewed and revised with the aim of updating the acceptable data requirements in light of experience gained and clarifying, where appropriate, the applicability of the MUMS data requirements. This guideline describes the data requirements regarding safety and residues for pharmaceutical veterinary medicinal products, and MRL application falling within the scope of MUMS/limited market. With regards to the safety data requirements the key consideration is whether the veterinary medicine is intended for treatment of a minor species rather than whether is designated as “minor use” or “limited market”. More information is available on the EMA’s website.

Date for coming into effect: 1st July, 2017

Quality data requirements for veterinary medicinal products
The European Medicines Agency have published: Scientific guideline: Guideline on quality data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market, adopted.

In order to stimulate the research, development and innovation of new veterinary medicines intended for minor uses or minor species (MUMS)/limited market the CVMP developed guidelines on data requirements for MUMS/limited market veterinary medicinal products for quality, safety and efficacy for pharmaceuticals and a guideline for immunologicals. These guidelines are intended to reduce data requirements where possible for products classified as MUMS/limited market while still providing assurance of the appropriate quality, safety and efficacy and complying with the legislation in place and leading to an overall positive benefit-risk balance for the product. These MUMS guidelines have now been reviewed and revised with the aim of updating the acceptable data requirements in light of experience gained and clarifying, where appropriate, the applicability of the MUMS data requirements. This guideline describes the data requirements regarding quality for pharmaceutical veterinary medicinal products classified as MUMS/limited market. More information is available on the EMA’s website.

Date for coming into effect: 1st July, 2017

Efficacy and target animal safety data requirements for veterinary medicinal products
The European Medicines Agency have published: Scientific guideline: Guideline on efficacy and target animal safety data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market, adopted.

In order to stimulate the research, development and innovation of new veterinary medicines intended for minor uses or minor species (MUMS)/limited market the CVMP developed guidelines on data requirements for MUMS/limited market veterinary medicinal products for quality, safety and efficacy for pharmaceuticals. These guidelines are intended to reduce data requirements where possible for products classified as MUMS/limited market while still providing assurance of appropriate quality, safety and efficacy and complying with the legislation in place and leading to an overall positive benefit-risk balance for the product. These MUMS guidelines have now been reviewed and revised with the aim of updating the acceptable data requirements in light of experience gained and clarifying, where appropriate, the applicability of the MUMS data requirements. This guideline describes the data requirements regarding efficacy and target animal safety for pharmaceutical veterinary medicinal products classified as MUMS/limited market. More information is available on the EMA’s website.

Date for coming into effect: 1st July, 2017

Electronic drug product reporting for human drug compounding outsourcing facilities
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.”

This guidance explains how facilities that elect to register with FDA as outsourcing facilities are to submit drug product reports, consistent with section 503B of the Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353b). Section 503B of the FD&C Act provides that a facility that elects to register with FDA as an outsourcing facility must report to FDA certain information about the drugs compounded at that outsourcing facility in the form and manner that FDA may “prescribe by regulation or guidance.” This guidance describes who must report and what information they must provide and explains that drug compounding reports must be submitted in structured product labeling (SPL) format using FDA’s electronic submissions system. More information is available on the FDA’s website.

Providing regulatory submissions in electronic format
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Providing Regulatory Submissions in Electronic Format—Submission of Manufacturing Establishment Information.”

This guidance discusses the requirements for a valid electronic submission of manufacturing establishment information (MEI) under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This action will streamline the review of all manufacturing establishments involved in the preparation of a drug or biological product by consolidating information in one location and eliminating the inclusion of erroneous and/or outdated information from other Agency files. More information is available on the Federal Register’s website.

Consultation Deadline: 27th February, 2017

Compounding and repackaging of radiopharmaceuticals by outsourcing facilities
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities.”

Specifically, this guidance sets forth FDA’s policy regarding compounding and repackaging of radiopharmaceuticals for human use by entities that are registered with FDA as outsourcing facilities. This guidance describes how FDA intends to apply section 503B of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to radiopharmaceuticals compounded by outsourcing facilities, and it describes the conditions under which FDA does not intend to take action for violations of certain provisions of the FD&C Act when an outsourcing facility repackages radiopharmaceuticals. More information is available on the Federal Register’s website.

Consultation Deadline: 27th February, 2017

Compounding and repackaging of radiopharmaceuticals by state-licensed nuclear pharmacies and federal facilities
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities.”

This guidance sets forth FDA’s policy regarding compounding and repackaging of radiopharmaceuticals for human use by State-licensed nuclear pharmacies and Federal facilities that are not registered as outsourcing facilities. Because such radiopharmaceuticals are not eligible for exemptions from provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) related to the production of drugs, FDA is issuing this guidance to describe the conditions under which it does not intend to take action for violations of certain provisions of the FD&C Act when a State-licensed nuclear pharmacy or Federal facility compounds or repackages radiopharmaceuticals. More information is available on the Federal Register’s website.

Consultation Deadline: 27th February, 2017

Prescription requirements for compounding human drug products
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act.”

This guidance sets forth the FDA’s policy concerning certain prescription requirements for compounding human drug products for identified individual patients under section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act or Act). It addresses compounding after the receipt of a prescription for an identified individual patient, compounding before the receipt of a prescription for an identified individual patient (anticipatory compounding), and compounding for office use (or office stock). More information is available on the FDA’s website.

Botanical drug development
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Botanical Drug Development.”

This guidance describes the Center for Drug Evaluation and Research’s (CDER’s) current thinking on appropriate development plans for botanical drugs to be submitted in new drug applications (NDAs) and specific recommendations on submitting investigational new drug applications (INDs) in support of future NDA submissions for botanical drugs. In addition, this guidance provides general information on the over-the-counter (OTC) drug monograph system for botanical drugs. Although this guidance does not intend to provide recommendations specific to botanical drugs to be marketed under biologics license applications (BLAs), many scientific principles described in this guidance may also apply to these products. More information is available on the FDA’s website.

Demonstration of biosimilarity to a reference product
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product.”

This guidance is intended to assist sponsors with the design and use of clinical pharmacology studies to support a decision that a proposed therapeutic biological product is biosimilar to its reference product. This guidance pertains to those products—such as therapeutic biological products—for which pharmacokinetic (PK) and pharmacodynamic (PD) data are needed to support a demonstration of biosimilarity. Specifically, the guidance discusses some of the overarching concepts related to clinical pharmacology testing for biosimilar products, approaches for developing the appropriate clinical pharmacology database, and the utility of modeling and simulation for designing clinical trials. More information is available on the FDA’s website.

Clinical development of medicinal products intended for the treatment of pain
The European Medicines Agency have published: Scientific guideline: Guideline on the clinical development of medicinal products intended for the treatment of pain – First version, adopted.

The scope of the present document is to provide guidance on the clinical development of new medicinal products intended for the treatment of nociceptive, neuropathic or mixed pain. Requirements with regard to study design, duration, target patient population and outcome measures are described, taking into account experience with marketing authorisation applications, scientific advice procedures, and developments in basic science and clinical guidelines since publication of the separate guidelines on neuropathic and nociceptive pain which the current guideline replaces and updates. The clinical investigation of medicinal products for the treatment of complex pain syndromes that have major elements other than nociceptive or neuropathic pain (including migraine for which there is a separate guideline) are not the focus of this guideline, although some general guidance is given on the data requirements to support claims for fibromyalgia. More information is available on the EMA’s website.

Date for coming into effect: 1st July, 2017

Post-authorisation efficacy studies
The European Medicines Agency have published: Scientific guideline: Scientific guidance on post-authorisation efficacy studies – First version, adopted.

This guidance has been developed in accordance with Article 108a of Directive 2001/83/EC which provides a mandate for European Medicines Agency (EMA) in cooperation with competent authorities and other interested parties to draw up scientific guidance on PAES. The intention is to provide scientific guidance for MAHs and for competent authorities on PAES in the context of EU regulatory decision-making with regard to the general need for such studies and general methodological considerations. For specific scenarios where PAES may be considered, additional clarifications are given together with study designs which may be applied. Some principles of study conduct are also highlighted. This guidance is not intended to replace or reproduce methods available in textbooks on various study designs but to highlight regulators’ particular considerations and the potential role of mentioned study designs for the PAES setting. More information is available on the EMA’s website.

Date for coming into effect: 1st June, 2017

Clinical investigation of human normal immunoglobulin for intravenous administration
The European Medicines Agency have published: Scientific guideline: Draft guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg), draft: consultation open.

This guideline describes the information to be documented when an application is made for a marketing authorisation for a human normal immunoglobulin for intravenous use (IVIg). The guidance covers biological data, clinical trials and patient follow-up. Quality aspects are outside the scope of this guideline. More information is available on the EMA’s website.

Consultation Deadline: 31st March, 2017

Core summary of product characteristics for human normal immunoglobulin for intravenous administration
The European Medicines Agency have published: Scientific guideline: Draft guideline on core summary of product characteristics for human normal immunoglobulin for intravenous administration (IVIg), draft: consultation open.

This guideline describes the information to be included in the Summary of Product Characteristics (SmPC) for human normal immunoglobulins for intravenous administration. More information is available on the EMA’s website.

Consultation Deadline: 31st March, 2017

Principles of regulatory acceptance of 3Rs
The European Medicines Agency have published: Scientific guideline: Guideline on the principles of regulatory acceptance of 3Rs (replacement, reduction, refinement) testing approaches, adopted.

In accordance with Directive 2010/63/EU, the principle of the 3Rs (Replacement, Reduction and Refinement) needs to be considered when selecting testing approaches to be used for regulatory testing of human and veterinary medicinal products. A general overview is provided on implementation of 3Rs principles in this context. More information is available on the EMA’s website.

ANDA Submissions – Refuse-to-Receive Standards
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “ANDA Submissions – Refuse-to-Receive Standards.”

This guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs) and prior approval supplements (PASs) to ANDAs for which the applicant is seeking approval of a new strength of the drug product. The guidance highlights deficiencies that may cause FDA to refuse to receive (RTR) an ANDA. An RTR decision indicates that FDA determined that an ANDA is not substantially complete. A substantially complete ANDA is “an ANDA that on its face is sufficiently complete to permit a substantive review.” More information is available on the FDA’s website.

Safety of residues of veterinary drugs in human food
The European Medicines Agency have published: Scientific guideline: VICH GL54 studies to evaluate the safety of residues of veterinary drugs in human food: general approach to establish an acute reference dose (ARfD), adopted.

The current guideline addresses the nature and types of data that can be useful in determining a toxicological acute reference dose (ARfD) for residues of veterinary drugs, the studies that may generate such data, and how the ARfD may be calculated based on these data. More information is available on the EMA’s website.

Date for coming into effect: 1st November, 2017

Production and control of immunological veterinary medicinal products
The European Medicines Agency have published: Scientific guideline: Guideline on requirements for the production and control of immunological veterinary medicinal products, adopted.

This document provides information on items to be considered for the production and control of all immunological veterinary medicinal products (IVMPs). The guideline outlines important items related to the quality, safety and efficacy parts of the marketing authorisation dossier that are not sufficiently defined in the requirements of Annex I of Directive 2001/82/EC and the European Pharmacopoeia (Ph. Eur.). Therefore compliance with this guideline (and the above mentioned regulatory documents) provides an assurance that the IVMP will be considered satisfactory by all the Member States. More information is available on the EMA’s website.

Date for coming into effect: 1st May, 2017

Extraneous agents of the seeds used for the production of immunological veterinary medicinal products
The European Medicines Agency have published: Scientific guideline: CVMP reflection paper on methods found suitable within the European Union for demonstrating freedom from extraneous agents of the seeds used for the production of immunological veterinary medicinal products, adopted.

According to Directive 2001/82/EC and relevant European Pharmacopoeia (Ph. Eur.) monographs (i.e. 0062, 0030, 5.2.4., 5.2.5.), immunological veterinary medicinal products and materials of biological origin used in their production should be demonstrated to be free from contamination with extraneous agents. More information is available on the EMA’s website.

Veterinary medicinal products for fluid therapy in case of diarrhoea
The European Medicines Agency have published: Scientific guideline: Concept paper for the revision of the guideline on veterinary medicinal products for fluid therapy in case of diarrhoea, draft: consultation open.

The guideline on veterinary medicinal products for fluid therapy in case of diarrhoea (7AE14a) was adopted in March 1992 and has been in force since September 1992. Following the review of current CVMP guidelines outlined in the ‘review and update of European Medicines Agency guideline to implement best practice with regard to 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products (EMA/CHMP/CVMP/JEG-3Rs/704685/2012), an issue for review was noted in the guideline on veterinary medicinal products for fluid therapy in case of diarrhoea (7AE14a; 1992) with regards to the 3Rs’ principles. Besides this issue, several other points were noted. More information is available on the EMA’s website.

Consultation Deadline: 31st March, 2017

Veterinary medicinal products for zootechnical purposes
The European Medicines Agency have published: Scientific guideline: Concept paper on the revision of the guideline for veterinary medicinal products for zootechnical purposes, draft: consultation open.

The current guideline for veterinary medicinal products for zootechnical purposes (7AE7a) was adopted in March 1992 and came into force in September 1992. The guideline concerns the documentation of the efficacy of zootechnical products and in particular the conduct of clinical trials in the target animal. The guideline gives the following definition of a veterinary medicinal product for zootechnical purposes: a product applied to a healthy animal for non-pathologic, i.e. non therapeutic claims to: synchronise oestrus, terminate unwanted gestation, prepare donors and recipients for the implantation of embryos, and improve fertility. The guideline therefore concerns, essentially, products active on the reproductive system (see also Directive 96/22/EEC, article 1(2)(c)). More information is available on the EMA’s website.

Consultation Deadline: 31st March, 2017

Guideline for residual solvents
The European Medicines Agency have published: Scientific guideline: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guideline Q3C (R5) on impurities: guideline for residual solvents – Step 5, adopted.

The objective of this guideline is to recommend acceptable amounts for residual solvents in pharmaceuticals for the safety of the patient. The guideline recommends use of less toxic solvents and describes levels considered to be toxicologically acceptable for some residual solvents. More information is available on the EMA’s website.

Date for coming into effect: 14th June, 2017

Use of electronic informed consent
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for institutional review boards, investigators and sponsors entitled “Use of Electronic Informed Consent: Questions and Answers.”

This guidance provides recommendations on the use of electronic systems and processes that may employ multiple electronic media to obtain informed consent for both HHS-regulated human subject research and FDA-regulated clinical investigations of medical products, including human drug and biological products, medical devices, and combinations thereof. More information is available on the FDA’s website.

Labelling and package-leaflet obligations in the centralised procedure
The European Medicines Agency have published: Regulatory and procedural guideline: Recommendations for the implementation of the exemptions to the labelling and package-leaflet obligations in the centralised procedure.

Rev.3 Changes since the last revision: Timing of submission of exemptions as per Art.63(1) and Art.63(3); clarifications on information to be submitted to NCAs when submitting a translation exemption at national level under Art.63(3); clarification on validity of exemptions granted as per Art.63(1) in the pre-authorisation phase. More information is available on the EMA’s website.

Publication of clinical data for medicinal products for human use
The European Medicines Agency have published: External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use.

The European Medicines Agency policy on the publication of clinical data for medicinal products for human use (hereafter referred to as ‘Policy 0070’) was developed by the European Medicines Agency (EMA), in accordance with Article 80 of Regulation (EC) No 726/2004. Policy 0070 was adopted by the EMA Management Board on 2nd October 2014 and subsequently published on the EMA website. Policy 0070 is composed of two phases. Phase 1 of Policy 0070 entered into force on 1st January 2015. Phase 1 pertains to publication of clinical reports only. Phase 2, which will be implemented at a later stage, pertains to the publishing of individual patient data (IPD). Clinical reports and IPD are collectively referred to as “clinical data”. The scope of this guidance document relates to phase 1 of Policy 0070. More information is available on the EMA’s website.

Chemistry of active substances
The European Medicines Agency have published: Scientific guideline: Guideline on the chemistry of active substances, adopted.

Guideline concerning the application of Directive 2001/83/EC with a view to the granting of a marketing authorisation for a medicinal product. This guideline replaces the ‘Note for guidance on chemistry of new active substances’ (CPMP/QWP/130/96, Rev 1) and ‘Chemistry of active substances’ (3AQ5a). It has been revised to cover new and existing active substances in one guideline. More information is available on the EMA’s website.

Date for coming into effect: 21st May, 2017

Medicinal products for the treatment of acute heart failure
The European Medicines Agency have published: Scientific guideline: Paediatric Addendum on the CHMP Guideline on clinical investigation of medicinal products for the treatment of acute heart failure, adopted.

This is an addendum to the Guideline on Clinical Investigation of Medicinal Products in the Treatment of Acute Heart Failure (CHMP/EWP/2986/03 Rev. 1) for adults and should be read in conjunction with this guideline. This addendum includes guidance on paediatric medicine clinical development, highlighting paediatric specific issues and differences from adult acute heart failure. More information is available on the EMA’s website.

Date for coming into effect: 1st June, 2017

Drug Supply Chain Security Act implementation
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.”

This guidance is intended to aid trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) in identifying a suspect product as defined at section 581(21) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee(21)) and terminating notifications. More information is available on the FDA’s website.

Small and medium-sized enterprises developing advanced therapy medicinal products
The European Medicines Agency have published: Regulatory and procedural guideline: Procedural advice on the certification of quality and non-clinical data for small and medium-sized enterprises developing advanced therapy medicinal products, adopted.

Update to section 5.2. to allow for electronic submission of the Certification application to EMA and CAT members, in line with current practice. More information is available on the EMA’s website.

Clinical Pharmacology section of labeling for human prescription drug and biological products
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products — Content and Format.”

This guidance is intended to assist applicants in preparing the CLINICAL PHARMACOLOGY section of prescription drug labeling (henceforth referred to as labeling) to meet regulatory requirements and ensure appropriate consistency in the format and content of this section for all prescription drugs approved by FDA. More information is available on the FDA’s website.

Clinical investigation of medicinal products for prevention of venous thromboembolism
The European Medicines Agency have published: Scientific guideline: Guideline on clinical investigation of medicinal products for prevention of venous thromboembolism (VTE) in non-surgical patients, adopted.

The aim of this guideline is to provide guidance regarding the development of medicinal products in the prevention of venous thromboembolism in non-surgical patients. The revised guideline does not deal with the development of medicinal products for prevention of long-term sequelae of VTE, such as postthrombotic syndrome or chronic thromboembolic pulmonary hypertension. This guideline replaces the ‘Guideline on clinical investigation of medicinal products for the prophylaxis of venous thromboembolic risk in non-surgical patients’ (CPMP/EWP/6235/04). More information is available on the EMA’s website.

Date for coming into effect: 1st June, 2017

Evaluation of the EMA fee system
DG SANTE has contracted out a study to support the evaluation of the fee system of the European Medicines Agency.

The project will start in December 2016 and will last for 15 months. More information is available on the Commission’s website.

Providing Postmarketing Periodic Safety Reports
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Providing Postmarketing Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report).”

This guidance describes the conditions under which applicants can use an alternative reporting format, the International Council for Harmonisation (ICH)3 E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER), in place of the U.S. periodic adverse drug experience report (PADER), U.S. periodic adverse experience report (PAER), or ICH E2C Periodic Safety Update Report (PSUR), to satisfy the periodic postmarketing safety reporting requirements in §§ 314.80(c)(2) and 600.80(c)(2) (21 CFR 314.80(c)(2) and 600.80(c)(2)). This guidance also describes the procedures applicants should follow if they wish to submit a PBRER in place of a PADER, PAER, or PSUR. More information is available on the FDA’s website.

Development of similar biological medicinal products containing low-molecular-weight-heparins
The European Medicines Agency have published: Scientific guideline: Guideline on non-clinical and clinical development of similar biological medicinal products containing low-molecular-weight-heparins, adopted.

This guideline lays down the non-clinical and clinical requirements for low molecular weight heparins (= low molecular mass heparins, LMWHs) containing medicinal products claimed to be biosimilar to another one already marketed. The quality section addresses some aspects specific to LMWH, the non-clinical section addresses the pharmaco-toxicological requirements and the clinical section the requirements for pharmacokinetic, pharmacodynamic and, where needed, safety/immunogenicity studies as well as pharmacovigilance aspects. More information is available on the EMA’s website.

Date for coming into effect: 1st June, 2017

Process validation for finished products
The European Medicines Agency have published: Scientific guideline: Guideline on process validation for finished products – information and data to be provided in regulatory submissions – Revision 1 , adopted.

This guideline replaces the previous note for guidance on process validation (CPMP/QWP/848/96, (EMEA/CVMP/598/99). The guideline is brought into line with ICH Q8, Q9 and Q10 documents and the possibility to use continuous process verification in addition to, or instead of, traditional process validation described in the previous guideline has been added and is encouraged. This is an update to the definition for “on-line” measurement included in the glossary and it is not intended as a full revision of this guideline. More information is available on the EMA’s website.

Approved pictograms on the packaging of veterinary medicinal products
The European Medicines Agency have published: Regulatory and procedural guideline: Draft QRD guidance on the use of approved pictograms on the packaging of veterinary medicinal products authorised via the centralised (CP), mutual recognition (MRP) and decentralised procedures (DCP), draft: consultation open.

The need for a harmonised, approved ‘catalogue’ of pictograms was identified and this draft guidance was developed as a collaboration between the QRD (vet) group, the CMDv, CVMP and industry stakeholders. The use of pictograms from Annex 1 of this guidance will apply to the national authorisation procedures, including MRP and DCP and to the centralised procedure (EMA). The aim of the guidance is to outline the approval requirements and processes where pictograms from Annex 1 are used on the product literature. More information is available on the EMA’s website.

Consultation Deadline: 25th February, 2017

Contract manufacturing agreements for drugs
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Contract Manufacturing Arrangements for Drugs: Quality Agreements.”

This guidance describes FDA’s current thinking on defining, establishing, and documenting manufacturing activities of the parties involved in contract drug manufacturing subject to current good manufacturing practice (CGMP) requirements. In particular, the FDA describes how parties involved in contract drug manufacturing can use quality agreements to delineate their manufacturing activities to ensure compliance with CGMP. More information is available on the FDA’s website.

Safety testing of drug metabolites
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Safety Testing of Drug Metabolites.”

This guidance provides recommendations to industry on when and how to identify and characterize drug metabolites whose nonclinical toxicity needs to be evaluated. The safety of drug metabolites may need to be determined in nonclinical studies because these metabolites are either identified only in humans or are present at disproportionately higher levels in humans than in any of the animal species used during standard nonclinical toxicology testing. This guidance applies to small molecule nonbiologic drug products. This guidance does not apply to some cancer therapies where a risk-benefit assessment is considered. This guidance supersedes the guidance of the same name published in February 2008. The guidance has been revised to be in alignment with the ICH guidance for industry M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals. More information is available on the FDA’s website.

Safety and effectiveness data for nonprescription sunscreen drug products
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Nonprescription Sunscreen Drug Products — Safety and Effectiveness Data.”

This guidance addresses the current thinking of the Food and Drug Administration’s (FDA or Agency) about the safety and effectiveness data needed to determine whether a nonprescription (also referred to as an over-the-counter (OTC)) sunscreen active ingredient, or combination of active ingredients, evaluated under the Sunscreen Innovation Act (SIA) (21 U.S.C. Ch. 9, Sub. 5 Part I, enacted November 26, 2014) is generally recognized as safe and effective (GRASE) and not misbranded when used under specified conditions. More information is available on the FDA’s website.

Data submissions for nonprescription sunscreen drug products
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Nonprescription Sunscreen Drug Products – Format and Content of Data Submissions.”

This guidance addresses the current thinking of the Food and Drug Administration (FDA or Agency) on the format and content of information provided to support a request submitted under section 586A (586A request) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360fff-1), as amended by the Sunscreen Innovation Act (SIA) (21 U.S.C. Ch. 9 Sub. 5 Part I, enacted November 26, 2014), or in support of a pending request, as defined under section 586(6) of the FD&C Act (21 U.S.C. 360fff(6)). More information is available on the FDA’s website.

User Fee Assessments Q&A for Generic Drug User Fee Amendments of 2012
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments.”

This guidance provides answers to anticipated user-fee questions from generic drug industry participants regarding the Generic Drug User Fee Amendments of 2012 (Public Law 112-144, Title III), commonly referred to as GDUFA. This guidance finalizes the user fee Q&A section of Revision 1 of the draft guidance. This final guidance document addresses comments FDA received on Revision 1, adds questions and answers that FDA and industry have discussed regarding user fees since the launch of the program, and finalizes the user fee section of the revised version of the guidance. More information is available on the FDA’s website.

Current regulatory testing requirements and opportunities for implementation of the 3Rs
The European Medicines Agency have published: Scientific guideline: Draft reflection paper providing an overview of the current regulatory testing requirements for medicinal products for human use and opportunities for implementation of the 3Rs, draft: consultation open.

The current reflection paper provides a snapshot of the testing requirements at the time of publication. It is to be expected that, over time, new testing approaches will become accepted and the tables will become out of date. In reviewing these tables the reader should remember that the fundamental responsibility of the CHMP is to ensure the quality, safety and efficacy of medicinal products and so to safeguard patient health. While the CHMP is committed to encouraging use of 3Rs approaches wherever possible, these cannot be accepted at the expense of safety and efficacy for patients. More information is available on the EMA’s website.

Consultation Deadline: 31st May, 2017

Clinical investigation of medicinal products in the treatment of depression
The European Medicines Agency have published: Scientific guideline: Concept paper on the need for revision of the guideline on clinical investigation of medicinal products in the treatment of depression, draft: consultation open.

The current guideline needs revision covering the latest developments with regard to requirements for clinical trials in partial and non-responders with MDD and options of targeting new functional domains. In addition, it may include requirements to increase depression clinical trials efficiency. More information is available on the EMA’s website.

Consultation Deadline: 28th February, 2017

Application of Articles 3, 5 and 7 of Regulation (EC) No 141/2000 on orphan medicinal products
The European Commission has published a notice on the application of Articles 3, 5 and 7 of Regulation (EC) No 141/2000 on orphan medicinal products.

On 29 July 2003, the Commission issued a Communication on Regulation (EC) No 141/2000 which considered points in relation to its Articles 3 (criteria for designation), 5 (procedure for designation and removal from the register) and 7 (Union marketing authorisation). This notice replaces the Communication. Its scope is the same: it is intended to facilitate the application of Articles 3, 5 and 7 of Regulation (EC) No 141/2000. More information is available on the Eur-Lex website.

First-in-human and early clinical trials with investigational medicinal products
The European Medicines Agency have published: Scientific guideline: Draft guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products, draft: consultation open.

The EMA ‘Guideline on strategies to identify and mitigate risks for first-in-human (FIH) clinical trials (CTs) with investigational medicinal products’ was published in 2007. It mainly addresses the non-clinical aspects of drug development. This reflects the practice at that time which focused on a single ascending dose design. Since then, integration of the non-clinical data available before FIH administrations and the pharmacokinetic, pharmacodynamic and human safety data emerging during a trial has evolved. Consequently, many FIH trials are now performed with integrated protocols potentially combining different study parts. This revision extends the guidance to early phase CTs including single study or integrated protocol designs. More information is available on the EMA’s website.

Consultation Deadline: 28th February, 2017

Non-inferiority clinical trials to establish effectiveness
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Non-Inferiority Clinical Trials to Establish Effectiveness.”

This document provides guidance to sponsors and applicants submitting investigational drug applications (INDs), new drug applications (NDAs), biologics licensing applications (BLAs), or supplemental applications on the appropriate use of non-inferiority (NI) study designs to provide evidence of the effectiveness of a drug or biologic, usually because a superiority study design (drug versus placebo, dose response, or superiority to an active drug) cannot be used. The guidance gives advice on when NI studies intended to demonstrate effectiveness of an investigational drug can provide interpretable results, how to choose the NI margin, and how to test the NI hypothesis. More information is available on the FDA’s website.

Clinical investigation of medicinal products to prevent development/slow progression of chronic renal insufficiency
The European Medicines Agency have published: Scientific guideline: Guideline on the clinical investigation of medicinal products to prevent development/slow progression of chronic renal insufficiency, adopted.

The main aim of the guideline was to address the clinical development of compounds used to prevent the development and to slow the progression of chronic renal insufficiency. The main focus of the guideline is on the conduct of clinical studies with medicinal products intended to prevent or slow progression of chronic renal insufficiency, describing different potential claims in relation to the kidney disorder (i.e., primary and secondary prevention), description of study populations including prognostic factors for the evolution of the kidney disorder and study objectives and endpoints. More information is available on the EMA’s website.

Date for coming into effect: 1st April, 2017

Development of the European medicines web portal
The European Medicines Agency have published: Regulatory and procedural guideline: Reflection paper on the development of the European medicines web portal.

This reflection paper discusses the provision of information on human medicines through the European medicines web portal and the opportunities this presents for EMA and its partners within the EU medicines regulatory network. More information is available on the EMA’s website.

Postmarketing requirements and commitments
The Food and Drug Administration (FDA or Agency) has published a Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments.

Under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), the Food and Drug Administration (FDA or Agency) is required to report annually in the Federal Register on the status of postmarketing requirements (PMRs) and postmarketing commitments (PMCs) required of, or agreed upon by, holders of approved drug and biological products. This notice is the Agency’s report on the status of the studies and clinical trials that applicants have agreed to, or are required to, conduct. More information is available on the Federal Register’s website.

Good Laboratory Practice for Nonclinical Laboratory Studies
The Food and Drug Administration (FDA) is extending the comment period for the proposal to amend the regulations for good laboratory practice (GLP) for nonclinical laboratory studies to require a complete quality system approach, referred to as a GLP Quality System, when safety and toxicity studies support or are intended to support applications or submissions for products regulated by FDA.

The FDA is proposing additional management responsibilities and standard operating procedures (SOPs) consistent with the proposed requirement for a GLP Quality System. We also propose to revise the testing facility definition to reflect current practices for the conduct of nonclinical laboratory studies, particularly multisite studies. These proposals are intended to build quality into planning, conducting, and reporting a nonclinical laboratory study and to help ensure data quality and integrity. More information is available on the Federal Register’s website.

Consultation Deadline: 21st January, 2017

Biopharmaceutics Classification System-based biowaivers
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is announcing the availability of a final endorsed concept paper entitled “M9: Biopharmaceutics Classification System-based Biowaivers.”

This proposed new multidisciplinary guideline will address Biopharmaceutics Classification System (BCS)-based biowaivers. This guideline will provide recommendations to support the biopharmaceutics classification of medicinal products and will provide recommendations to support the waiver of bioequivalence studies. This will result in the harmonisation of current regional guidelines/guidance and support streamlined global drug development. More information is available on the ICH website.

Bioanalytical method validation
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is announcing the availability of a final endorsed concept paper entitled “M10: Bioanalytical Method Validation.”

The proposed new multidisciplinary guideline will apply to the validation of bioanalytical methods and study sample analyses in non-clinical and clinical studies. This guideline will provide recommendations on the scientific regulatory requirements for bioanalysis conducted during the development of drugs of both chemical and biological origins. This will result in the harmonisation of current regional guidelines/guidances and support streamlined global drug development. More information is available on the ICH website.

Non-clinical documentation for herbal medicinal products
The European Medicines Agency have published: CVMP strategy on antimicrobials 2016-2020.

The Committee adopted the revised CVMP strategy on antimicrobials for the period 2016-2020. The CVMP vision on antimicrobials aims to ensure the availability of effective antimicrobial medicines for the treatment of infectious diseases of animals while, at the same time, minimising the risks to animals or humans arising from their use. The strategy intends to strengthen the benefit-risk assessment for antimicrobial veterinary medicinal products in a One Health context. More information is available on the EMA’s website.

15th round of negotiations for the Transatlantic Trade and Investment Partnership
The European Commission has published the report of the 15th round of negotiations for the Transatlantic Trade and Investment Partnership.

The state-of-play and the organisation of the evaluation of the US and the EU GMP inspectorates were discussed. In light of the progress achieved, the conclusion of a mutual recognition agreement of Good Manufacturing Practices (GMPs) inspections, by January 2017, is under consideration. There are however a number of matters still to be agreed/discussed between the Parties, notably as regard the scope of the provisions and operational implementation. More information is available on the Commission’s website.

ANDA Submissions – Prior Approval Supplements Under GDUFA
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled “ANDA Submissions – Prior Approval Supplements Under GDUFA.”

This guidance is intended to assist applicants preparing to submit to FDA prior approval supplements (PASs) and amendments to PASs for abbreviated new drug applications (ANDAs) under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)). The guidance explains how the Generic Drug User Fee Amendments of 2012 (GDUFA) relates to PAS submissions. The guidance also describes the performance metric goals outlined in the GDUFA Commitment Letter that FDA has agreed to meet, and clarifies how FDA will handle a PAS and amendments to a PAS for an ANDA subject to the GDUFA performance metric goals. More information is available on the FDA’s website.

Clinical investigation of medicinal products in the pediatric population
The European Medicines Agency have published: Scientific guideline: ICH E11(R1) guideline on clinical investigation of medicinal products in the pediatric population: Step 2b, draft: consultation open.

The purpose of the addendum is to complement and provide clarification and current regulatory perspective on topics in pediatric drug development. More information is available on the EMA’s website.

Consultation Deadline: 13th April, 2017

Core SmPC for human Anti-D immunoglobulin for intramuscular use
The European Medicines Agency have published: Scientific guideline: Guideline on the core SmPC for human Anti-D immunoglobulin for intramuscular use, adopted.

This guideline describes the information to be included in the Summary of Product Characteristics (SmPC) for a human anti-D immunoglobulin for intramuscular use. With respect to the previous version, this Core SmPC has been adapted to the current QRD template. The method of administration for overweight patients has been specified. More information is available on the EMA’s website.

Date for coming into effect: 1st April, 2017

Core SmPC for human Anti-D immunoglobulin for intravenous use
The European Medicines Agency have published: Scientific guideline: Guideline on the core SmPC for human Anti-D immunoglobulin for intravenous use, adopted.

This guideline describes the information to be included in the Summary of Product Characteristics (SmPC) for a human anti-D immunoglobulin for intravenous use. With respect to the previous version, this Core SmPC has been adapted to the current QRD template. More information is available on the EMA’s website.

Date for coming into effect: 1st April, 2017

Safety features on the packaging of medicinal products for human use
The European Commission has published: Commission Delegated Regulation EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use.

The delegated act detailing the characteristics of the safety features, how medicine authenticity should be verified, and by whom, was adopted on 2nd October 2015 and published, after scrutiny by the European Parliament and the Council, on 9th February 2016. To facilitate the implementation of the delegated Regulation, the Commission has also prepared a “Questions and Answers” document.

In addition, the regulatory requirements to be followed to notify the EMA of the placing of the unique identifier and/or the anti-tampering device on centrally authorised products are detailed in an implementation plan developed by the EMA and the European Commission and published in the “product information templates” section of the EMA website.

More information is available on the Commission’s website.

Date for coming into effect: 9th February, 2019