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.

Notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol
The European Medicines Agency have published: Scientific guideline: Draft guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol, draft: consultation open.

This guideline outlines the practical arrangements for notification of serious breaches of clinical trials authorised in the Europe Union / European Economic Area. It aims to provide advice on what should and what should not be classified as a serious breach and what must be reported. It does not include guidance related to urgent safety measures or other reporting obligations related to subject safety. More information is available on the EMA’s website.

Consultation Deadline: 22nd August, 2017

EMA 2016 Annual Report
The European Medicines Agency (EMA) has published its 2016 annual report.

The report focuses on the Agency’s key achievements in the areas of medicine evaluation, support to research and development of new and innovative treatments and the safety monitoring of medicines in real life. It also highlights some of the Agency’s main projects, initiatives and achievements in 2016, contains three interviews with stakeholders and EMA representatives on topics of major interest in the area of medicines and health in 2016 , and provides a large amount of data and figures that illustrate the work of EMA and its impact. More information is available on the EMA’s website.

Evaluation of medicinal products indicated for treatment of influenza
The European Medicines Agency have published: Scientific guideline: Concept paper on a guideline on the evaluation of medicinal products indicated for treatment of influenza, draft: consultation open.

This concept paper proposes the development of a guideline on the clinical evaluation of medicinal products indicated for the treatment of influenza for which there is no regulatory guidance currently available within the EU. More information is available on the EMA’s website.

Consultation Deadline: 31st August, 2017

Information guide for healthcare professionals on biosimilar medicines
The European Medicines Agency (EMA) and the European Commission have published an information guide for healthcare professionals on biosimilar medicines.

The objective of the guide is to provide healthcare professionals with reference information on both the science and regulation underpinning the use of biosimilars. More information is available on the EMA’s website.

Procedural advice for users of the centralised procedure for similar biological medicinal product applications
The European Medicines Agency have published: Regulatory and procedural guideline: European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal product applications.

This document addresses a number of questions which users of the Centralised Procedure may have. It provides an overview of the EMA position on issues, which are typically addressed during the course of Pre-Submission Meetings. More information is available on the EMA’s website.

Preparation for Brexit by marketing authorisation holders of centrally authorised medicinal products
The European Commission and the European Medicines Agency have issued a “Notice to marketing authorisation holders of centrally authorised medicinal products for human and veterinary use”, reminding marketing authorisation holders of centrally authorised medicines of their legal obligations in preparation for Brexit.

More information is available on the EMA’s website.

Strategic approach to pharmaceuticals in the environment
The European Commission has published the roadmap “Strategic approach to pharmaceuticals in the environment.” The Roadmap aims to inform stakeholders about the Commission’s work in order to allow them to provide feedback and to participate effectively in future consultation activities

More information is available on the Commission’s website.

SmPC and package leaflet for iopamidol 300
The European Medicines Agency have published: Scientific guideline: Draft guideline on Guideline on core summary of product characteristics (SmPC) and package leaflet for iopamidol 300, draft: consultation open.

This document describes the information to be included in the summary of product characteristics and package leaflet for iopamidol 300. More information is available on the EMA’s website.

Consultation Deadline: 31st August, 2017

Expiration dates of doxycycline tablets and capsules
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for government public health and emergency response stakeholders entitled “Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles.”

This document, once finalized, will provide guidance to government stakeholders on testing to extend the shelf life (i.e., expiration date) under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) of stockpiled doxycycline tablets and capsules for public health emergency preparedness and response purposes for an anthrax emergency. This draft guidance has been prepared in response to requests from States asking FDA what would be necessary to provide confidence that stockpiled doxycycline tablets and capsules have retained their original quality beyond the manufacturer’s labeled expiration date so the replacement of stockpiled product could be deferred. This guidance and any resulting expiration date extensions authorized by FDA do not apply to doxycycline available commercially or otherwise held for any other non-emergency purpose. More information is available on the Federal Register’s website.

Consultation Deadline: 26th June, 2017

Bioequivalence studies for veterinary medicinal products
The European Medicines Agency have published: Scientific guideline: Draft revised guideline on the conduct of bioequivalence studies for veterinary medicinal products, draft: consultation open.

It is the objective of this guideline to specify requirements for the design, conduct, and evaluation of bioequivalence studies for pharmaceutical forms with systemic action. In addition, guidance is given on how in vitro data in specific cases may be used to allow bridging of safety and efficacy data. More information is available on the EMA’s website.

Consultation Deadline: 31st October, 2017

Generic naloxone hydrochloride nasal spray
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a new draft guidance for industry on generic naloxone hydrochloride nasal spray entitled “Draft Guidance on Naloxone Hydrochloride.”

The new draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for naloxone hydrochloride nasal spray. More information is available on the Federal Register’s website.

Consultation Deadline: 23rd June, 2017

Immunological veterinary medicinal products intended for minor use or minor species (MUMS)/limited market
The European Medicines Agency have published: Scientific guideline: Guideline on data requirements for immunological veterinary medicinal products intended for minor use or minor species (MUMS)/limited market – Revision 3, adopted.

In order to stimulate the development of new veterinary medicines intended for minor uses or minor species (MUMS)/limited market the CVMP developed a guideline on data requirements for MUMS/limited market for immunological veterinary medicinal products (IVMPs). This MUMS guideline has 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 these data requirements. More information is available on the EMA’s website.

Date for coming into effect: 1st November, 2017

GCP compliance in relation to trial master file
The European Medicines Agency have published: Scientific guideline: Draft guideline on good clinical practice compliance in relation to trial master file (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials, draft: consultation open.

The guideline on Trial Master File (TMF) aims to describe the requirements for TMF as covered in the new Clinical Trials Regulation (EU) No 536/2014 and ICH-GCP E6 and to assist organisations in maintaining a TMF that facilitates trial management, good-clinical-practice (GCP) compliance and inspection. The document also addresses archiving of the TMF, clarifying retention times, in particular expectations in case of digitisation and consecutive destruction of paper documentation. More information is available on the EMA’s website.

Consultation Deadline: 11th July, 2017

Publication of clinical data for medicinal products for human use
The European Medicines Agency have published: Regulatory and procedural guideline: External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use – Version 1.2, adopted.

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. More information is available on the EMA’s website.

Clinical data publication (CDP)
The European Medicines Agency have published: Regulatory and procedural guideline: Questions and answers (Q&As) on the external guidance of Policy 0070 on clinical data publication (CDP).

This page lists some questions that applicants/Marketing Authorisation Holders (MAHs) may have on the procedure for the publication of clinical data. It provides an overview of the European Medicines Agency’s position on issues that are typically addressed in discussions or meetings with applicants/MAHs. It will be updated regularly to reflect any new guidance updates during the implementation of Policy 0070. New or revised questions are marked with ‘New’ or ‘Rev’ together with the relevant date. More information is available on the EMA’s website.

Good clinical practice inspection procedures
The European Commission has published: Commission Implementing Regulation (EU) 2017/556 of 24 March 2017 on the detailed arrangements for the good clinical practice inspection procedures pursuant to Regulation (EU) No 536/2014 of the European Parliament and of the Council.

More information is available on the Commission’s website.

Date for coming into effect: 25th September, 2017

Revision of the guideline on the investigation of drug interactions
The European Medicines Agency have published: Scientific guideline: Concept paper on a revision of the guideline on the investigation of drug interactions, draft: consultation open.

The first revision of the Guideline on the investigation of drug interactions (CPMP/EWP/560/95/Rev. 1 Corr. 2) was adopted by the CHMP in June 2012. This concept paper proposes a further update to reflect recent scientific knowledge and experience in applying the guideline since it came into force. More information is available on the EMA’s website.

Consultation Deadline: 30th June, 2017

Equivalence studies for the demonstration of therapeutic equivalence for products that are locally applied, locally acting in the GIT
The European Medicines Agency have published: Scientific guideline: Draft guideline on equivalence studies for the demonstration of therapeutic equivalence for products that are locally applied, locally acting in the gastrointestinal tract as addendum to the guideline on the clinical requirements for locally applied, locally acting products containing known constituents, draft: consultation open.

This guideline defines the requirements that need to be fulfilled to waive clinical trials with clinical or pharmacodynamic endpoints in the demonstration of therapeutic equivalence for locally applied, locally acting gastrointestinal products. It also defines the in vivo bioequivalence studies and in vitro equivalence tests that are necessary. More information is available on the EMA’s website.

Consultation Deadline: 30th September, 2017

Collaboration between the European Medicines Agency and academia
The European Medicines Agency have published: Regulatory and procedural guideline: Framework of collaboration between the European Medicines Agency and academia, adopted.

This framework aims to reinforce and further develop the collaboration between the European Medicines Agency (EMA hereafter) and academia by clarifying scope, formalising and structuring interactions in the wider context of the European regulatory system for medicines. More information is available on the EMA’s website.

Multiplicity issues in clinical trials
The European Medicines Agency have published: Scientific guideline: Draft guideline on multiplicity issues in clinical trials, draft: consultation open.

This guideline is intended to provide guidance on how to deal with multiple comparison and control of type I error in the planning and statistical analysis of clinical trials. From the points to consider document published in 2002, aspects related with multiplicity issues in safety, drug-response studies, secondary endpoints, subgroup analysis and estimation were added or updated, and statistical terms were clarified. More information is available on the EMA’s website.

Consultation Deadline: 30th September, 2017

Statistical methodology for the comparative assessment of quality attributes in drug development
The European Medicines Agency have published: Scientific guideline: Draft reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development, draft: consultation open.

The reflection paper provides current regulatory considerations regarding statistical aspects for the comparative assessment of quality attributes in the settings of pre- and post-manufacturing change, biosimilar development as well as generics development. It raises open issues from a methodological perspective addressing questions related to comparison objectives, sampling strategies, sources of variability, acceptance ranges and statistical analysis approaches to conclude on the similarity of two drug products based on quality attribute data. A main objective of the reflection paper is to establish a framework and a common language to facilitate future discussion among stakeholders and to invite comments in relation to the issues raised. More information is available on the EMA’s website.

Consultation Deadline: 31st March, 2018

Evaluation of anticancer medicinal products in man
The European Medicines Agency have published: Scientific guideline: Concept paper on the need to revise Condition – Specific guidance, Appendix 4 to the guideline on the evaluation of anticancer medicinal products in man, draft: consultation open.

The guideline on anticancer medicinal products as revised in early 2010 (rev.3)1 included disease specific guidance which was later expanded (rev. 4 published January 2013) to constitute a separate appendix (Appendix 4). The Appendix 4 was recently revised (rev 2 published February 2016). This concept paper describes and discusses the basis for the revision to the existing Appendix 4 in relation to the use of minimal residual disease (MRD) as a clinical endpoint in multiple myeloma (MM) clinical studies. More information is available on the EMA’s website.

Consultation Deadline: 30th June, 2017

Clinical development of fixed combination medicinal products
The European Medicines Agency have published: Scientific guideline: Guideline on clinical development of fixed combination medicinal products – Revision 2, adopted.

This is the 2nd revision of the guideline on clinical development of fixed combination medicinal products containing two or more active substances within a single pharmaceutical form. The active substances may be authorised substances or substances that have not yet been authorised in the EU. This guideline addresses the clinical development requirements of fixed combination medicinal products, which shall reflect their intended therapeutic use and indication independent of the chosen legal basis for the submission of the marketing authorisation application. More information is available on the EMA’s website.

Date for coming into effect: 1st October, 2017

Qualified Person Declaration
The Heads of Medicines Agencies have published: CMDh Questions and Answers, QP Declaration, Revision 2.

The CMDh agreed an update of the Q&A document on QP declaration. A new Q&A has been added to clarify the need for QP declaration(s) in support of certain changes to a Marketing Authorisation, to confirm that the active substance is manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials. More information is available on the CMDh website.

Implementation of the Falsified Medicines Directive
The Heads of Medicines Agencies have published: CMDh clarifications on questions received on the implementation of the Falsified Medicines Directive.

Following the receipt of several queries on the implementation of the Falsified Medicines Directive over the last year, the CMDh has agreed to publish, for transparency reasons, the feedback given to those queries. More information is available on the CMDh website.

European Commission report on the summary of product characteristics and the package leaflets
The European Commission has published a report to the European Parliament and the Council on the summary of product characteristics and the package leaflets.

This report was prepared pursuant to Article 59(4) of Directive 2001/83/EC according to which the Commission shall present to the European Parliament and the Council an assessment report on current shortcomings in the summary of product characteristics and the package leaflet and how they could be improved in order to better meet the needs of patients and healthcare professionals. More information is available on the Commission’s website.

Provision of data on antimicrobial use by animal species from national data collection systems
The European Medicines Agency have published: Scientific guideline: Draft guidance on provision of data on antimicrobial use by animal species from national data collection systems, draft: consultation open.

This guidance aims to set standards for data on antimicrobial use by animal species from national data collection systems and to define the type and format of those data. The guidance should allow for the collation, analysis and reporting of reliable, harmonised and standardised data on antimicrobial use by animal species/category in EU/EEA Member States and across time periods. A Question and answer document on the guidance has been prepared, providing clarification and the rationale for some of the recommendations made in the document. More information is available on the EMA’s website.

Consultation Deadline: 24th September, 2017

Plant testing strategy for veterinary medicinal products
The European Medicines Agency have published: Scientific guideline: Guideline on the plant testing strategy for veterinary medicinal products, adopted.

Guidance on how to perform Tier A and Tier B plant testing, including an explanation of the SSD approach for higher tier assessment, was provided in the reflection paper on testing strategy and risk assessment for plants. The current guideline replaces this reflection paper and provides additional options for a higher tier assessment for plants. More information is available on the EMA’s website.

Date for coming into effect: 1st October, 2017

Developing drugs for prevention of delayed graft function in kidney transplantation
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention.”

The purpose of this guidance is to assist sponsors in the clinical development of drugs for the prevention of delayed graft function (DGF) in kidney transplantation. More information is available on the Federal Register’s website.

Consultation Deadline: 21st June, 2017

Clinical documentation for orally inhaled products
The European Medicines Agency have published: Scientific guideline: Concept paper on revision of the guideline on the requirements for clinical documentation for orally inhaled products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatment of asthma and chronic obstructive pulmonary disease (COPD) in adults and for the treatment of asthma in children and adolescents, draft: consultation open.

This concept paper concerns a revision of the guideline directed to the requirements for demonstration of therapeutic equivalence between two inhaled products. The guideline focuses on hybrid applications but may be applicable also for other applications that are based on demonstration of therapeutic equivalence compared to a reference product, such as line extensions and variations. The guideline was originally published in September 2000 and was revised between September 2007 and January 2009. More information is available on the EMA’s website.

Consultation Deadline: 22nd June, 2017

Pharmaceutical quality of inhalation and nasal products
The European Medicines Agency have published: Scientific guideline: Concept paper on revision of the guideline on the pharmaceutical quality of inhalation and nasal products, draft: consultation open.

This concept paper concerns the guidance document on quality aspects of human medicinal products intended for delivery of drug substance into the lungs or to the nasal mucosa with the purpose of evoking local or systemic effect. These include pressurised metered dose inhalers, dry powder inhalers, products for nebulisation and non-pressurised metered dose inhalers as well as pressurised metered dose nasal sprays, nasal powders and nasal liquids. More information is available on the EMA’s website.

Consultation Deadline: 22nd June, 2017

Hypertension indication: drug labeling for cardiovascular outcome claims
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims.”

This guidance is intended to assist applicants in developing labeling for cardiovascular outcome claims for drugs that are indicated to treat hypertension. With few exceptions, current labeling for antihypertensive drugs includes only the information that these drugs are indicated to reduce blood pressure; the labeling does not include information on the clinical benefits related to cardiovascular outcomes expected from such blood pressure reduction. However, blood pressure control is well established as beneficial in preventing serious cardiovascular events, and inadequate treatment of hypertension is acknowledged as a significant public health problem. The Food and Drug Administration (FDA) believes that the appropriate use of these drugs can be encouraged by making the connection between lower blood pressure and improved cardiovascular outcomes more explicit in labeling. This guidance recommends standard labeling for antihypertensive drugs except where differences in labeling are supported by clinical data. More information is available on the FDA’s website.

Implementation strategy of ICH Q3D guideline
The European Medicines Agency have published: Scientific guideline: Implementation strategy of ICH Q3D guideline, adopted.

The purpose of this document is to address specific considerations to enable the practical implementation of ICH Q3D Guideline for Elemental Impurities in the European Union. It is intended to provide guidance for Applicants/MAHs, drug product, drug substance and excipient manufacturers, as well as regulators. In addition to new applications, it will also apply to variations to existing authorised medicinal products. More information is available on the EMA’s website.

Quality of water for pharmaceutical use (H+V)
The European Medicines Agency have published: Scientific guideline: Concept paper on the need for revision of note for guidance on quality of water for pharmaceutical use (H+V), draft: consultation open.

This concept paper addresses the need to update and revise the Note for Guidance on Quality of water for pharmaceutical use (CPMP/QWP/158/01 EMEA/CVMP/115/01). This guideline was originally adopted in May 2002 and came into operation on 1st June 2002. More information is available on the EMA’s website.

Consultation Deadline: 6th June, 2017

Scientific data for use in HMPC assessment work
The European Medicines Agency have published: Regulatory and procedural guideline: Procedure for calls for scientific data for use in HMPC assessment work, adopted.

In accordance with Directive 2001/83/EC as regards traditional herbal medicinal products through Directive 2004/24/EC, it is the task of the Committee on Herbal Medicinal Products (HMPC) to establish a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (Article 16f). Furthermore, the HMPC shall establish European Union herbal monographs for herbal medicinal products (Article 16h). The HMPC has also undertaken to ensure that monographs and list entries remain up-to-date (scientific state of the art) by assessing regularly the need for their revision. The legislation does not specify how scientific data relating to the assessment work for the monographs and list entries should be identified and compiled. The HMPC discussed a number of possibilities and agreed on a practice subject to 3 conditions. More information is available on the EMA’s website.

Updated EU-US agreement on mutual recognition of inspections of medicine manufacturers
The European Commission has published the full text of an agreement adopted between the European Commission and the United States Food and Drug Administration to mutually recognise inspections of premises where medicines are produced.

With this update of the 1998 Agreement on good manufacturing practices, EU and US regulatory authorities will be able to rely on each other’s information as regards facilities in the EU or US that manufacture medicines and active pharmaceutical ingredients for the European and American markets. The agreement will not affect the process of approving medicines, as it focuses only on inspections of manufacturing sites. The enhanced cooperation with US regulatory authorities will improve the EU’s ability to identify and address problems at factories before they become a public health risk. It will also reduce the administrative burdens and costs facing pharmaceutical manufacturers, including smaller producers. More information is available on the Commission’s website.

Triggers for inspections of bioequivalence trials
The European Medicines Agency have published: Regulatory and procedural guideline: Guidance on triggers for inspections of bioequivalence trials: quick scan, adopted.

This document represents a non-exhaustive overview of issues, which are taken into account during the assessment phase. Identification of other triggers not mentioned in this document is possible. This list is to be considered a quick scan. The topics listed in this document are intended to assist the assessor in deciding on whether to consult or to seek input from their GCP inspectorate on the need for a GCP inspection and on the best way forward. More information is available on the EMA’s website.

Traditional herbal medicinal products and simplified registrations for homeopathic medicinal products
The European Medicines Agency have published: Regulatory and procedural guideline: Traditional herbal medicinal products and simplified registrations for homeopathic medicinal products: pharmacovigilance requirements and EudraVigilance access – Note for clarification.

The purpose of this document is to clarify pharmacovigilance requirements for traditional herbal medicinal products registered further to a simplified registration procedure (traditional use-registration) on the basis of Article 16a of Directive 2001/83/EC1 and homeopathic medicinal products registered further to the special, simplified registration procedure under Article 14(1) of Directive 2001/83/EC and the process for obtaining access to adverse reaction reports in EudraVigilance for traditional use herbal medicinal products. More information is available on the EMA’s website.

EMA Adaptive Pathways Workshop
The European Medicines Agency have published a report on the Adaptive Pathways Workshop – a meeting with stakeholders that was held at EMA on Thursday 8 December 2016.

The European Medicines Agency held this workshop in collaboration with the European Commission to gather the views and proposals from stakeholders on the adaptive pathways approach, in light of the practical experience gained during the pilot project EMA ran between March 2014 and August 2016, and to plan the next steps in the exploration of this concept. Adaptive pathways is a scientific concept of medicines development and data generation intended for medicines that address patients’ unmet medical needs. EMA will publish the presentations, video recording and a workshop report on this page. More information is available on the EMA’s website.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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

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.

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.

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.

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

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