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.

Identifying trading partners under the Drug Supply Chain Security Act
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Identifying Trading Partners Under the Drug Supply Chain Security Act” (draft trading partner guidance).

FDA is issuing this guidance to assist industry and State and local governments in understanding how to categorize the entities in the drug supply chain in accordance with the Drug Supply Chain Security Act (DSCSA). This guidance explains how to determine when certain statutory requirements will apply to entities that may be considered trading partners in the drug supply chain. FDA is also soliciting public input specific to the activities of “private-label distributors” of drug products and whether those activities fall within the definitions under DSCSA of the various trading partners. More information is available on the Federal Register’s website.

Consultation Deadline: 20th October, 2017

Dissolution specification for generic solid oral immediate release products with systemic action
The European Medicines Agency have published: Scientific guideline: Reflection paper on the dissolution specification for generic solid oral immediate release products with systemic action – First version.

This paper discusses the suitability of the dissolution method and the specifications for in vitro dissolution of orally administered generic drug products with immediate release characteristics. Where applicable, this reflection paper should be read in connection with the principles of relevant guidelines listed as references. More information is available on the EMA’s website.

Comments on dissolution specification for generic solid oral immediate release products with systemic action
The European Medicines Agency have published: Scientific guideline: Overview of comments received on ‘Draft reflection paper on the dissolution specification for generic solid oral immediate release products with systemic action’ – First version.

This document lists the comments submitted by interested parties (organisations or individuals) on the draft document as released for consultation, together with the responses of the EMA. More information is available on the EMA’s website.

Manufacture of the finished dosage form
The European Medicines Agency have published: Scientific guideline: Guideline on manufacture of the finished dosage form, adopted.

This guideline replaces the note for guidance on the manufacture of the finished dosage form (CPMP/QWP/486/95). The note for guidance has been updated to reflect the requirements as laid down in the current legislation Directive 2001/83/EC, and to follow the format and content of the Common Technical Document (CTD) Module 3 dossier. It also addresses current manufacturing practices in terms of complex supply chains and worldwide manufacture. In addition, the content and principles of the ICH Q8 guideline (ref 1) are also taken into account. More information is available on the EMA’s website.

Date for coming into effect: 14th February, 2018

Expiration dating of unit-dose repackaged solid oral dosage form drug products
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled “Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products.”

The last few decades have seen an increasing demand in various health care settings for solid oral dosage form drug products repackaged into unit-dose containers, which hold a quantity of drug for administration as a single dose. The increase in unit-dose repackaging has led to questions regarding stability studies and appropriate expiration dates for these repackaged products. This revised draft guidance describes the conditions under which FDA does not intend to take action regarding required stability studies for these repackaged products and the expiration date to assign under those conditions. Through this notice, FDA is hoping to decrease the regulatory burdens of drug regulations on manufacturers of these products, while at the same time ensuring patient safety. Since FDA’s guidance documents do not bind the public or FDA to any requirements, they have not been considered to be subject to Executive Order 12866. More information is available on the Federal Register’s website.

Consultation Deadline: 10th October, 2017

CMC postapproval manufacturing changes for specified biological products
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports.”

This draft guidance provides recommendations to holders of biologics license applications (BLAs) for specified products regarding the types of changes to be documented in annual reports. Specifically, the draft guidance describes chemistry, manufacturing, and controls (CMC) postapproval manufacturing changes that the Agency generally considers to have a minimal potential to have an adverse effect on the identity, strength, quality, purity, or potency of the product as they may relate to the safety or effectiveness of the product. Under FDA regulations, such minor changes in the product, production process, quality controls, equipment, facilities, or responsible personnel must be documented by applicants in an annual report. More information is available on the Federal Register’s website.

Consultation Deadline: 10th October, 2017

Clinical development of new agents to treat pulmonary disease due to Mycobacterium tuberculosis
The European Medicines Agency have published: Scientific guideline: Addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections to address the clinical development of new agents to treat pulmonary disease due to Mycobacterium tuberculosis – Revision 1, adopted.

This revision of the Addendum to the Note for guidance on the evaluation of medicinal products for treatment of bacterial infections to address the clinical development of new agents to treat disease due to Mycobacterium tuberculosis (EMA/CHMP/EWP/14377/2008 Rev. 1) has been produced in response to recent advances and changes in focus in the field. More information is available on the EMA’s website.

Date for coming into effect: 1st February, 2018

Child-resistant packaging statements in drug product labeling
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Child-Resistant Packaging Statements in Drug Product Labeling.”

This guidance is intended to assist applicants, manufacturers, packagers, and distributors who choose to include child-resistant packaging (CRP) statements in prescription and over-the-counter human drug product labeling. The guidance discusses what information should be included to support CRP statements and to help ensure that such labeling is clear, useful, informative, and, to the extent possible, consistent in content and format. More information is available on the Federal Register’s website.

Consultation Deadline: 2nd October, 2017

Pharmaceutical development of medicines for use in the older population
The European Medicines Agency have published: Scientific guideline: Reflection paper on the pharmaceutical development of medicines for use in the older population – First version, draft: consultation open.

The reflection paper describes aspects that medicines developers may consider when designing medicines for older people, such as selecting appropriate routes of administration and dosage forms, dosing frequency, excipients, container closure systems, devices and technologies, and user instructions in the product information. More information is available on the EMA’s website.

Consultation Deadline: 31st January, 2018

Non-clinical evaluation of radiopharmaceuticals
The European Medicines Agency have published: Scientific guideline: Concept paper on the development of guidance on the non-clinical evaluation of radiopharmaceuticals – First version, draft: consultation open.

This concept paper is intended to seek external stakeholder views on potential guidance development related to overarching considerations for non-clinical data in support of clinical development and approval of radiopharmaceuticals. This guidance is intended to complement currently available guidelines (such as ICH M3(R2), ICH S6(R1), ICH S9 or the EMA Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products) and includes the different intended uses of radiopharmaceuticals including radiodiagnostics as well as radiotherapeutics. The paper will focus on opportunities to targeted non-clinical programs according to specific development settings and product types and is not intended to duplicate guidance related to dosimetry. More information is available on the EMA’s website.

Consultation Deadline: 31st October, 2017

Antibacterial therapies for patients with an unmet medical need for the treatment of serious bacterial diseases
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases.”

This guidance is intended to assist sponsors in the clinical development of new antibacterial drugs. Specifically, the guidance explains the FDA’s current thinking about possible streamlined development programs and clinical trial designs for antibacterial drugs to treat serious bacterial diseases in patients with an unmet medical need, including patients who have a serious bacterial disease for which effective antibacterial drugs are limited or lacking. More information is available on the FDA’s website.

Predictive biomarker-based assay development in the context of drug development and lifecycle
The European Medicines Agency have published: Scientific guideline: Concept paper on predictive biomarker-based assay development in the context of drug development and lifecycle, draft: consultation open.

The proposed concept paper is intended to be developed into a guideline which will replace the reflection paper on co-development of pharmacogenomic biomarkers and assays in the context of drug development. The guideline will provide recommendations on the interface between predictive biomarker-based assays including companion diagnostic and the development and lifecycle of a medicine. More information is available on the EMA’s website.

Consultation Deadline: 15th November, 2017

Guideline on Influenza vaccines – Quality module
The European Medicines Agency have published: Scientific guideline: Guideline on Influenza vaccines – Quality module Revision 1, adopted.

The need to update the current guidelines regarding the quality, non-clinical and clinical development of influenza vaccines was recognised in the wake of the 2009-2010 influenza pandemic, as the Agency conducted its “lessons learnt” exercise. More information is available on the EMA’s website.

Date for coming into effect: 1st February, 2018

Data elements for transmission of individual case safety reports
The European Medicines Agency have published: Scientific guideline: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use topic E 2 B (R3): Questions and answers: Data elements for transmission of individual case safety reports – Step 5, adopted.

This Q&A document provides clarifications for the harmonized interpretation of the E2B(R3) IG package and should be reviewed in conjunction with the IG package. This will facilitate the implementation of the electronic transmission of Individual Case Safety Reports (ICSRs) in the ICH regions. The sections of this Q&A document corresponds to the organization of the E2B(R3) IG. More information is available on the EMA’s website.

Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk
The European Medicines Agency have published: Scientific guideline: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guideline M7 (R1) on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk – Step 5, adopted.

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 reside or are reasonably expected to reside in final drug substance or product, taking into consideration the intended conditions of human use. More information is available on the EMA’s website.

Date for coming into effect: 1st February, 2018

Use of aminoglycosides in animals in the European Union
The European Medicines Agency have published: Scientific guideline: Draft reflection paper on use of aminoglycosides in animals in the European Union: development of resistance and impact on human and animal health, draft: consultation open.

In April 2013, the European Commission (EC) requested advice from the European Medicines Agency (EMA) on the impact of the use of antibiotics in animals on public and animal health and measures to manage the possible risk to humans. The advice was provided by the Antimicrobial Advice ad hoc Expert Group (AMEG). As part of the advice, the AMEG provided a categorisation of antimicrobials according to their risk for public health. This CVMP/AWP reflection paper considers a recommendation from the AMEG for further risk profiling to be undertaken for the aminoglycosides (AGs) to enable them to be placed within the AMEG’s categorisation. More information is available on the EMA’s website.

Consultation Deadline: 31st October, 2017

Off-label use of antimicrobials in veterinary medicine in the European Union
The European Medicines Agency have published: Scientific guideline: Draft reflection paper on off-label use of antimicrobials in veterinary medicine in the European Union, draft: consultation open.

This document intends to define off-label use and provide relevant examples of off-label use of antimicrobials in animals and the underlying reasons for these practices. The circumstances when off-label use is compatible with responsible use of antimicrobials will be explored. The goal is to identify and focus on areas that may cause unacceptable public and animal health risks due to dissemination of antimicrobial resistance. Off-label antimicrobial use in companion animals and food-producing animals will be addressed. More information is available on the EMA’s website.

Consultation Deadline: 31st January, 2018

First-in-human and early clinical trials with investigational medicinal products
The European Medicines Agency have published: Scientific guideline: Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products – Revision 1, adopted.

This document addresses non-clinical and clinical issues for consideration prior to the first administration of an investigational medicinal product in humans. It also addresses the design and conduct of early clinical trials, including trials with integrated protocols. Emphasis is put on defining the uncertainty associated with the medicine tested at each step of the development and describing how the potential risks that might arise from this uncertainty will be addressed. The revision was made in cooperation with the EU Clinical Trials Facilitation Group (CTFG). More information is available on the EMA’s website.

Date for coming into effect: 1st February, 2018

Allogenic stem cell-based products for veterinary use
The European Medicines Agency have published: Scientific guideline: Questions and Answers on allogenic stem cell-based products for veterinary use: Specific questions on extraneous agents, adopted.

Freedom from extraneous agents is a crucial aspect of quality evaluation of stem cell-based preparations. Therefore, appropriate acceptance criteria for starting and raw materials of human or animal origin need to be established. Following a review of the scientific information relating to stem cells, a number of areas have been identified that would benefit from further consideration by relevant experts and, where appropriate, the elaboration of specific guidance in the form of question and answer document (Q&A). Three specific questions for further consideration have been identified relating to freedom from extraneous agents aspects. More information is available on the EMA’s website.

Quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells
The European Medicines Agency have published: Scientific guideline: Concept paper on the revision of the guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells – Superceding document, draft: consultation open.

This Concept Paper proposes a revision of the Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells (EMA/CAT/GTWP/671639/2008) that came into effect in 2012. The guideline covers all cases of genetically modified cells intended for use in humans, independent of whether the genetic modification has been carried out for clinical indication (i.e. gene therapy medicinal products), for manufacturing purposes or any other reason. The genetically modified cells can be of human origin (autologous or allogeneic) or animal origin (xenogeneic cells), either primary or established cell lines. Genetically modified cells of bacterial origin are excluded from the scope of this guideline. The revised guideline referred to in this concept paper will replace guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells (EMA/CAT/GTWP/671639/2008). More information is available on the EMA’s website.

Consultation Deadline: 31st October, 2017

Promotion of pharmacovigilance reporting
The European Medicines Agency have published: Scientific guideline: Reflection paper on promotion of pharmacovigilance reporting, adopted.

Experience to date within the regulatory network suggests that there may be an issue relating to under-reporting of adverse events associated with the use of veterinary medicinal products (VMPs) particularly with regard to use in food producing animals. This document will provide an overview of the different tools used by national competent authorities (NCAs) and the European Medicines Agency (EMA or the ‘Agency’) to date to promote pharmacovigilance (PhV) reporting. In addition, further activities that may be beneficial in increasing PhV reporting in general and particularly with regard to food producing animals will be examined. More information is available on the EMA’s website.

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 Self-Identification of Facilities, Review of Generic Drug Submissions, and Inspections and Compliance.”

This guidance provides answers to questions arising from the implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA) (Public Law 112-144, Title III), commonly referred to as GDUFA. The questions and answers (Q&A) format is intended to promote transparency and facilitate compliance by the generic drug industry. The first draft of this document was issued pursuant to 21 CFR 10.115 in August 2012 and a revised draft was issued in September 2013. FDA is issuing the final guidance as two separate guidances. This guidance includes questions and answers related to self-identification, review of generic drug submissions, and inspections and compliance. This final guidance clarifies some of the questions and answers included in the previous versions based on FDA’s experience in implementing GDUFA. More information is available on the FDA’s website.

Pilot project program under the Drug Supply Chain Security Act
The Food and Drug Administration (FDA or Agency) is announcing its intent to establish a pilot project program under the Drug Supply Chain Security Act (the DSCSA Pilot Project Program) to assist in development of the electronic, interoperable system that will identify and trace certain prescription drugs as these are distributed within the United States.

Under this program, FDA will work with stakeholders to establish one or more pilot projects to explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain. Participation in the DSCSA Pilot Project Program will be voluntary and will be open to pharmaceutical distribution supply chain members. FDA will be particularly interested in participation reflecting the diversity of the supply chain, including large and small entities from all industry sectors. This notice describes the proposed DSCSA Pilot Project Program, including proposed instructions for submitting a request to participate. FDA is soliciting comments on the proposed collection of information associated with establishment of the DSCSA Pilot Project Program before submitting the proposed collection to the Office of Management and Budget (OMB) for approval. FDA does not intend to begin the proposed DSCSA Pilot Project Program or accept requests to participate in the program until OMB has approved the proposed collection of information. More information is available on the Federal Register’s website.

Consultation Deadline: 18th September, 2017

Involvement of young patients/consumers within EMA activities
The European Medicines Agency have published: Regulatory and procedural guideline: Principles on the involvement of young patients/consumers within EMA activities, adopted.

The purpose of this document is to establish the principles for the involvement of young patients, consumers, and their carers, in the activities of the Agency’s scientific committees and working parties in a consistent and efficient manner, whenever such involvement is appropriate in the interest of the ongoing scientific assessment within a particular (scientific) committee. More information is available on the EMA’s website.

NORs, PARs, DSp and normal variability of process parameters
The European Medicines Agency have published: Scientific guideline: Questions and answers: improving the understanding of normal operating range (NOR), proven acceptable range (PAR), design space (DSp) and normal variability of process parameters.

This question and answer document is aimed at improving the understanding of NORs, PARs, DSp and normal variability of process parameters. More information is available on the EMA’s website.

European Union individual case safety report (ICSR) implementation guide
The European Medicines Agency have published: Regulatory and procedural guideline: European Union individual case safety report (ICSR) implementation guide, adopted.

This guidance specifies the technical requirements and the process of transmission of individual case safety reports (ICSRs) and is applicable to all stakeholders, which are exchanging ICSRs electronically within the European Economic Area. More information is available on the EMA’s website.

Pharmaceutical Quality/Chemistry Manufacturing and Control (PQ/CMC) data elements and terminologies
The Food and Drug Administration (FDA or Agency) is requesting comment on the draft standardized Pharmaceutical Quality/Chemistry Manufacturing and Control (PQ/CMC) data elements and terminologies for the electronic submission of PQ/CMC data.

The establishment of standardized pharmaceutical quality data elements and terminologies will provide opportunities for FDA and industry to transform PQ/CMC submission data into a readily useable electronic format. As a result, these established data elements and terminologies will improve the efficiency and quality of the drug review process. The Agency is seeking comment on the accuracy, suitability, and appropriateness of these data elements and terminologies for submission of PQ/CMC data. FDA is considering implementing PQ/CMC requirements as a Health Level 7 (HL7) Structured Product Labeling (SPL) document. More information is available on the Federal Register’s website.

Consultation Deadline: 11th September, 2017

Pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products
The European Medicines Agency have published: Scientific guideline: Concept paper on an addendum on terms and concepts of pharmacogenomic features related to metabolism to the Guideline on the use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products (EMA/CHMP/37646/2009), draft: consultation open.

This addendum to the guideline on the use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products (EMA/CHMP/37646/2009) intends to provide clear definitions of terms used for metabolic phenotyping, as well to propose concepts regarding the translation of genotypes into the predicted metabolic phenotype, of significant importance for the correct treatment of patients. More information is available on the EMA’s website.

Consultation Deadline: 10th October, 2017

Selection and justification of starting materials for the manufacture of chemical active substances
The European Medicines Agency have published: Scientific guideline: Reflection paper on the requirements for selection and justification of starting materials for the manufacture of chemical active substances, adopted.

This reflection paper aims to clarify some of the expectations of EU competent authorities arising from the guidance found in ICH Q11 (Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) regarding the information to be submitted in marketing authorisation dossiers to justify the selection of starting materials. Whilst ICH Q11 is not generally applicable to veterinary products, the principles outlined in this document should apply equally for active substances destined to treat both humans and animals. More information is available on the EMA’s website.

Product identifier requirements Under the Drug Supply Chain Security Act
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Product Identifier Requirements Under the Drug Supply Chain Security Act—Compliance Policy.”

This draft guidance describes FDA’s intention with regard to enforcement of requirements related to product identifiers under the Drug Supply Chain Security Act (DSCSA). Specifically, this guidance addresses manufacturers’ product identifier and verification requirements, which begin November 27, 2017. This guidance also addresses certain requirements for repackagers, wholesale distributors, and dispensers to only engage in transactions involving products with product identifiers and to verify the product identifier when investigating suspect product, in addition to repackager and wholesale distributor requirements related to saleable returned products. More information is available on the Federal Register’s website.

Consultation Deadline: 1st September, 2017

Development of non-substantially manipulated cell-based ATMPs
The European Medicines Agency have published: Regulatory and procedural guideline: Development of non-substantially manipulated cell-based advanced therapy medicinal products: flexibility introduced via the application of the risk-based approach.

This document aims to illustrate some of the possibilities and limitations of the risk-based approach using the example of an ATMP based on cells that have not been subjected to substantial manipulation and that are not intended for the same essential function: a de-novo development of autologous bone marrow or peripheral blood CD34+ cells for treatment of acute myocardial infarction. More information is available on the EMA’s website.

Gaucher disease: a strategic collaborative approach from the EMA and FDA
The European Medicines Agency have published: Scientific guideline: Gaucher disease: a strategic collaborative approach from the European Medicines Agency and Food and Drug Administration, adopted.

This Strategic Collaborative Approach document is not a formal guidance; the purpose of this document is to facilitate paediatric drug development particularly in the field of Gaucher disease. The general principles presented should be viewed as suggestions only. More information is available on the EMA’s website.

Current Good Manufacturing Practice for medical gases
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled “Current Good Manufacturing Practice for Medical Gases.”

This guidance is intended to assist manufacturers of medical gases in complying with applicable current good manufacturing practice (CGMP) regulations. Compliance with applicable CGMP requirements helps to ensure the safety, identity, strength, quality, and purity of medical gases. Medical gases that are not manufactured, produced, processed, packed, or held according to applicable CGMP requirements can cause serious injury or death. This guidance is expected to reduce the regulatory compliance burden for the medical gas industry by providing clear, up-to-date, detailed recommendations regarding CGMP issues that have been the subject of industry questions. More information is available on the Federal Register’s website.

Consultation Deadline: 28th August, 2017

Criteria to waive target animal batch safety testing for inactivated vaccines for veterinary use
The European Medicines Agency have published: Scientific guideline: VICH GL50: Harmonisation of criteria to waive target animal batch safety testing for inactivated vaccines for veterinary use – Revision 1, adopted.

The objective of this guideline is to provide internationally harmonized recommendations for criteria on data requirements to waive target animal batch safety testing of inactivated veterinary vaccines in regions where it is required. More information is available on the EMA’s website.

Date for coming into effect: 1st May, 2018

Criteria to waive target animal batch safety testing for live vaccines for veterinary use
The European Medicines Agency have published: Scientific guideline: VICH GL55: Harmonization of criteria to waive target animal batch safety testing for live vaccines for veterinary use – First version, adopted.

The objective of this guideline is to provide internationally harmonized recommendations for criteria on data requirements to waive target animal batch safety testing of live veterinary vaccines in regions where it is required. More information is available on the EMA’s website.

Date for coming into effect: 1st May, 2018

Revision of the guideline on clinical development of vaccines
The European Medicines Agency have published: Scientific guideline: Concept paper on revision of the guideline on clinical development of vaccines, draft: consultation open.

The Guideline on clinical evaluation of vaccines (EMEA/CHMP/VWP/164653/2005) was developed during 2005-2006 and came into operation in 2007. It covers the design of clinical development programmes for new vaccines that are intended to provide pre- and post-exposure prophylaxis against infectious diseases. Some of the guidance provided is also relevant to the further development of licensed vaccines (i.e. generation of clinical data to support changes to the prescribing information in the post-authorisation period). Much of what this guideline says is still fully relevant to current vaccine clinical development but a revision is proposed to address issues that have come to light since it came into operation. More information is available on the EMA’s website.

Consultation Deadline: 30th September, 2017

Allogenic stem cell-based products for veterinary use
The European Medicines Agency have published: Scientific guideline: Questions and Answers on allogenic stem cell-based products for veterinary use: specific questions on sterility, adopted.

Following a review of the scientific information relating to stem cells, a number of areas have been identified that would benefit from further consideration by relevant experts and, where appropriate, the elaboration of specific guidance in the form of a questions and answers document (Q&A). More information is available on the EMA’s website.

Use of electronic records and electronic signatures in clinical investigations
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Use of Electronic Records and Electronic Signatures in Clinical Investigations under our regulations—Questions and Answers.”

The draft guidance provides guidance to sponsors, clinical investigators, institutional review boards (IRBs), contract research organizations (CROs), and other interested parties on the use of electronic records and electronic signatures under our regulations in clinical investigations of medical products. The draft guidance expands upon recommendations in the guidance for industry entitled “Part 11, Electronic Records; Electronic Signatures—Scope and Application” issued in August 2003 (referred to as the 2003 part 11 guidance) for recommendations that pertain to FDA-regulated clinical investigations conducted under our regulations. More information is available on the Federal Register’s website.

Consultation Deadline: 21st August, 2017

European Commission Safety Features Q&A document updated
The European Commission has published an updated version, Version 7, of the Questions and Answers document on the Safety Features for Medicinal Products for Human Use.

Version 7 of the document, dated June 2017, supersedes Version 5. Q&As 1.15, 1.16, 2.14, 2.15, 2.16, 5.4, 5.5 and 7.12 were added to the document, while Q&As 1.8, 3.4, 4.3 5.3, 7.11 and 8.1 were revised. More information is available on the Commission’s website.

ANDAs: Pre-submission facility correspondence associated with priority submissions
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “ANDAs: Pre-Submission Facility Correspondence Associated with Priority Submissions.”

The Pre-Submission Facility Correspondence (PFC) process was identified as part of the performance goals and program enhancements for the Generic Drug User Fee Amendments reauthorization for Fiscal Years 2018-2022 (GDUFA II). A complete and accurate PFC allows the Agency to begin the facility assessment process in advance of the planned abbreviated new drug application (ANDA) submission. This draft guidance describes PFC content and format, as well as the Agency’s approach to assessing this information. More information is available on the Federal Register’s website.

Consultation Deadline: 18th September, 2017

Clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final revised guidance for industry entitled “E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs — Questions and Answers (R3).”

This guidance is a revision of the ICH guidance titled E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs – Questions and Answers (November 2008). More information is available on the FDA’s website.

Development of medicinal products for chronic non-infectious liver diseases
The European Medicines Agency have published: Scientific guideline: Concept paper on the need for the development of a reflection paper on regulatory requirements for the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH), draft: consultation open.

There is an unmet medical need of pharmaceutical treatment options in the indications Primary Sclerosing Cholangitis (PSC) and Non-alcoholic steatohepatitis (NASH) and also the repertoire of effective and safe drugs for the treatment for Primary Biliary Cholangitis (PBC; previously termed “Primary Biliary Cirrhosis”) remains limited. Whereas the number of development programs and potential future drug candidates has increased during recent years the current regulatory experience reveals the need for further guidance. Therefore the drafting of a reflection paper on regulatory requirements for the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH) is intended in order to address and to avoid potential pitfalls in drug development. More information is available on the EMA’s website.

Consultation Deadline: 31st August, 2017

Regulatory guidance for industry to prepare for the UK’s withdrawal from the EU
The European Medicines Agency (EMA) and the European Commission have published guidance to help pharmaceutical companies to prepare for the United Kingdom’s withdrawal from the European Union. The guidance relates to both human and veterinary medicines.

The questions-and–answers document concerns information related to the location of establishment of a company in the context of centralised procedures and certain activities, including the location of orphan designation holders, qualified persons for pharmacovigilance (QPPVs) and companies’ manufacturing and batch release sites. More information is available on the EMA’s website.

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

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

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

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

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

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

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.

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

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.

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.

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.

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.

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

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