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Jan 5, 2021

 
MHRA Guidance on Substantial Amendments to a Clinical Trial
On 31 December 2020 the MHRA published guidance on substantial amendments to a clinical trial.

This guidance describes the information about when substantial amendments need to be submitted to a clinical trial including changes to the trial sponsor or legal representative, investigational medicinal product certification and importation.

From 1 January 2021 either the sponsor or the legal representative of a clinical trial must be established in the UK or in a country on an approved country list. This list includes EU/European Economic Area (EEA) countries.

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Exceptions and Modifications to the EU Guidance on Good Pharmacovigilance Practices that Apply to UK Marketing Authorization Holders and the Licensing Authority
On 31 December 2020 the MHRA published a guidance note on GVP.

GVP are a set of measures drawn up to facilitate the performance of pharmacovigilance in the EU.

GVP apply to marketing authorization holders (MAHs), the EMA and medicines regulatory authorities in EU member states. They cover medicines authorized centrally through the EMA as well as medicines authorized at the national level.

This guidance describes the aspects of the EU guidance on GVP that no longer apply to the MHRA and UK MAHs, or are to be read subject to modification.

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MHRA Guidance on Submitting Clinical Trial Safety Reports
On 31 December 2020 the MHRA published the guidance on how to submit Suspected Unexpected Serious Adverse Drug Reactions (SUSARs) and annual safety reports Development Safety Update Reports (DSURs).

Company must submit SUSARs in Great Britain and in Northern Ireland to the MHRA in one of the following ways:

  • using the eSUSAR website
  • using the ICSR Submissions
  • using the MHRA Gateway

If company intends to submit SUSARs using one of the new reporting routes, it must register first.

For trials ongoing in both the UK and in European member states, dual reporting is needed. Company will need to report each SUSAR to both the MHRA and to the EMA’s Eudravigilance Clinical Trial Module (EVCTM).

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Providing Regulatory Submissions in Electronic Format — Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling
On 23 December 2020 the FDA published the final guidance for industry.

Under section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379k-1(a)), beginning no earlier than 24 months after the issuance of this final guidance in which the FDA has specified the electronic format for submitting certain submission types to the Agency, the content of such submission types must be submitted electronically, and in the format specified by FDA. This guidance describes the format requirements for the electronic submission of the content of a risk evaluation and mitigation strategy (REMS) document under section 745A(a) of the FD&C Act. This guidance describes how FDA will implement the requirements for the electronic submission of REMS documents as part of submissions under new drug applications (NDAs), abbreviated new drug applications (ANDAs), and, as described in Section III, certain biologics license applications (BLAs). Consistent with section 745A(a) of the FD&C Act, beginning 24 months after the issuance of this final guidance, REMS documents must be submitted to FDA in structured product labeling (SPL) format.

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Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices — Questions and Answers (Revised)
On 22 December 2020 the FDA published the updated Q&A guidance for industry and FDA staff.

FDA is issuing this guidance to provide answers to frequently asked questions about regulatory and policy issues related to device development for the duration of the COVID-19 public health emergency.

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Review Timelines for Applicant Responses to Complete Response Letters When a Facility Assessment Is Needed During the COVID-19 Public Health Emergency — Guidance for Industry
On 21 December 2020 the FDA announced the availability of the final guidance for industry.

FDA is issuing this guidance to provide information pertaining to review timelines that FDA will use during the COVID-19 public health emergency for the following applicant responses to complete response (CR) letters when a facility assessment is necessary before FDA can take action on a marketing application:

  • Amendments to original and supplemental abbreviated new drug applications (ANDAs) submitted to FDA under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
  • Resubmissions of original and supplemental biologics license applications (BLAs) submitted to FDA under sections 351(a) and (k) of the Public Health Service (PHS) Act.
  • Resubmissions of original and supplemental new drug applications (NDAs) submitted to FDA under sections 505(b)(1) and (2) of the FD&C Act.

Specifically, the guidance explains how FDA will determine review timelines following issuance of a CR letter when a facility assessment is necessary for FDA’s regulatory decision on an original or supplemental application. This guidance applies to inspections of manufacturing facilities and also bioresearch monitoring (BIMO) program sites conducting clinical, analytical, and nonclinical studies.

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Procedural Advice for Post-orphan Medicinal Product Designation Activities
On 21 December 2020 the EMA published the guidance for sponsors.

The opinions on orphan designation are adopted by the Committee for Orphan Medicinal Products (COMP) at their monthly meetings at the EMA.

Following adoption of an opinion on orphan medicinal product designation by the COMP, the final COMP opinion (negative or positive) is forwarded to the European Commission (EC) and the sponsor. Relevant information is published in the COMP monthly reports and the meeting minutes on EMA website. The decision on the designation is adopted by the EC within 30 days of receipt of the COMP opinion and forwarded to the sponsor via courier.

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EMA Updated Clinical Trials Information System Development
On 18 December 2020 the EMA published the updated clinical trials information system (CTIS) development.

In 2021, EMA plans to focus on:

  • the findings of a system audit;
  • improving usability, quality and stability of the CTIS;
  • knowledge transfer to prepare users and their organizations for CTIS.

It is also working towards go-live in line with a plan developed together with the Member States and to deliver a minimum viable product (MVP). The CTIS program governance is responsible for agreeing what the MVP will consist of.

Go-live is planned in December 2021.

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Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion
On 17 December 2020 the FDA announced the availability of the final guidance for industry.

This guidance document provides blood collection establishments and transfusion services with recommendations to control the risk of bacterial contamination of room temperature stored platelets intended for transfusion. The recommendations in this guidance apply to all platelet products stored at room temperature in plasma or additive solutions, including platelets manufactured by automated methods (apheresis platelets), and Whole Blood derived (WBD) single and pooled (pre-storage and post-storage) platelets.

Additionally, this guidance provides licensed blood establishments with recommendations on how to report implementation of manufacturing and labeling changes under Title 21 of the Code of Federal Regulations (CFR) 601.12.

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EMA Updated IRIS Guide for Applicants
On 17 December 2020 the EMA published the updated version 1.9 of IRIS guide for industry and individual applicants.

This guide has been produced to show applicants how to use the IRIS platform to prepare and submit an application for a scientific procedure (e.g. orphan designation application, scientific advice, or ITF briefing meeting request) and related activities.

For Parallel Distribution procedures separate user access roles are needed and separate guidance is available on the IRIS home page.

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Dry Eye: Developing Drugs for Treatment
On 16 December 2020 the FDA announced the availability of the draft guidance for industry. Comments may be submitted until 17 March 2021.

This guidance is intended to provide recommendations to sponsors regarding eligibility criteria, trial design considerations, and efficacy endpoints to enhance clinical trial data quality and to foster greater efficiency in development programs for drugs for the treatment of dry eye.

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Controlled Correspondence Related to Generic Drug Development Guidance for Industry
On 16 December 2020 the FDA published the final guidance for industry.

This guidance provides information regarding the process by which generic drug manufacturers and related industry or their representatives can submit to FDA controlled correspondence requesting information related to generic drug development. This guidance also describes the Agency’s process for providing communications related to such correspondence.

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Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products
On 16 December 2020 the FDA announced the availability of the final guidance for industry.

This document provides guidance to sponsors and applicants on interacting with the FDA on complex innovative trial design (CID) proposals for drugs or biological products. FDA is issuing this guidance to satisfy, in part, a mandate under section 3021 of the 21st Century Cures Act (Cures Act). In accordance with the Cures Act mandate, this guidance discusses the use of novel trial designs in the development and regulatory review of drugs and biological products, how sponsors may obtain feedback on technical issues related to modeling and simulation, and the types of quantitative and qualitative information that should be submitted for review.

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EMA Updated Questions and Answers on Labelling Flexibilities for COVID-19 Vaccines
On 16 December 2020 the EMA published the revision 1 of Q&A document on labelling flexibilities for COVID-19 vaccines.

The European Medicines Agency (EMA) together with the Member States, in the context of the Quality Review of Documents (QRD) group, have developed this Questions and Answers (Q&A) document with the aim to provide operational guidance on labelling flexibilities for COVID-19 vaccines. The topics addressed in the present document are primarily based on the European Commission’s Memorandum of Understanding (MoU) with Member States on regulatory flexibility for COVID-19 vaccines; in addition, a number of these topics are stemming from numerous questions received from COVID-19 vaccine developers in the course of the last few months.

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EMA Updated Guidance on Good Manufacturing Practice and Good Distribution Practice: Questions and Answers
On 16 December 2020 the EMA updated Q&A guidance on GMP and GDP in EU GMP guide part I, chapter 5.

Medicinal products that are relabeled or repacked with the purpose of parallel trade should be in compliance with any specific national legislation or guidance in relation to the batch number(s) that are to be present on the parallel distributed traded packs.

In the absence of specific national legislation or guidance, the outer packaging should have only one batch number, as allocated by the parallel trader. This batch number allocated by the parallel trader should incorporate two components; (1) the batch number of the original pack and (2) a unique code identifying the repackaging/relabeling run. The code for the repackaging run may comprise numbers or letters or a combination of both. The parallel trader’s batch number should be such that Component 1 above (originator batch number) is followed by Component 2 (a code related to the repackaging/relabeling run on that batch). Any deviation from this approach should be presented to and should be authorized by the supervisory authority. The traceability between the original batch number and the parallel trader’s batch number should be documented in the manufacturer’s repackaging records.

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