Posted on 12 Feb 2021

Regulatory News February

Invitation to webinar on Real world research on medicines: contribution of the European Network of Centres in Pharmacoepidemiology and Pharmacovigilance (ENCePP) on 8 March 2021:

EMA coordinates the European Network of Centres in Pharmacoepidemiology and Pharmacovigilance (ENCePP) which mission is to strengthen the monitoring of the benefit-risk balance of medicinal products in Europe by: 

·         facilitating the conduct of high quality, multi-centre, independent observational post-authorisation studies,

·         bringing together expertise and resources in pharmacoepidemiology and pharmacovigilance across Europe, and

·         developing and maintaining best practice for research.

ENCePP also provides and maintains a publicly available and searchable resource database and the European Union Post-authorisation study (PAS) Register.

In line with its Regulatory Science Strategy Plan to 2025, EMA is committed to further develop the existing interactions between the EU regulatory network and Academia, in view to keep each other informed of relevant scientific innovations and research, as well as to identify solutions to regulatory needs and challenges.  

EMA is organizing this upcoming webinar to provide the opportunity for Academia communities / Learned societies to gain in-depth information about ENCePP, specifically:

·         What the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) is;

·         How ENCePP contributes to improving pharmaco-epidemiological research, especially in circumstances such as the current COVID-19 pandemic;

·         Practical information on how to get involved in ENCepp.

You are cordially invited to join this upcoming event (agenda/Event Webpage).

When: March 8 2021 (10:00-12:00 CET)

Registration: Participation in the virtual meeting room is limited to representatives of academic communities and learned societies. It is free of charge.

To participate, please register by filling in this electronic form (in Google Chrome or Firefox) by 18:00 on 19 February 2021. EMA will inform those who register by the deadline whether they can participate in the virtual meeting.

Broadcast: The webinar will be broadcast live. There is no need to register to follow the live broadcast.

Direct healthcare professional communication (DHPC): Metamizole: Risk of drug-induced liver injury

This direct healthcare professional communication (DHPC) contains important information for healthcare professionals prescribing, dispensing or administering the medicine(s). It also includes a communication plan with details of intended recipients and the dissemination date

Article on “The European Medicines Agency's EU conditional marketing authorisations for COVID-19 vaccines”

(published in the medical journal “The Lancet” on 13 Jan 2021). Conditional marketing authorisation (CMA) is used in EU legislation for emergency situations in response to public health threats to speed up approval and save lives. This article explains in details EMA’s evaluation process that led to the recommendation of the first EU CMA for a COVID-19 vaccine. Please check EMA’s dedicated webpage on COVID-19 for the latest updates.

Recent EMA’s communications on COVID-19 vaccines:

Adverse reactions, medical device incidents and health product recalls in Canada: 2019 summary report available.

Each year, Health Canada receives thousands of reports of suspected adverse reactions about drugs and natural health products and of suspected medical device incidents. These reports contribute to Health Canada’s post-market monitoring of health product safety. This page summarizes data on adverse reaction reports received by Health Canada during 2019 and key trends over the past 10 years. Data on adverse drug reactions and medical device incidents are based on reports sent to Health Canada through the Canada Vigilance Program. Recall data are based on the work of the Regulatory Operations and Enforcement Branch. The statistics on this page are based only on Canadian reports and do not include data from other countries (foreign reports).


Health Canada releases Notice of clarification to drug manufacturers and sponsors: Canadian-specific considerations in risk management plans. 

Canada released the Submission of Risk Management Plans and Follow-up Commitments guidance document in June 2015. This guidance outlines the requirements for submitting a Canadian RMP in the European Union (EU) format or other recognized formats, such as the U.S. Risk Evaluation and Mitigation Strategy (REMS). It also describes the requirements and process for RMP follow-up commitments and updates to Health Canada. The notice is meant to help drug manufacturers and sponsors when preparing the Canadian-specific considerations and elements in the risk management plans (RMPs) for certain drug products. This notice describes what is required for certain drug products. It does not add new requirements for the submission of RMPs in Canada.


FDA Guidance on Providing Regulatory Submissions in Electronic Format - Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling released. 

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. It also 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 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 SPL format.

FDA Final Guidance on Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products released. 

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. Additional recommendations related to the mandate set forth in section 3021 of the Cures Act are addressed in FDA’s guidance on Adaptive Designs for Clinical Trials of Drugs and Biologics (Ref. 1). This guidance finalizes the draft guidance of the same title dated September 2019.

FDA Draft Guidance on Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act released. 

This draft guidance document provides answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilar products and proposed interchangeable products, as well as describe FDA’s interpretation of certain statutory requirements added by the BPCI Act.

FDA’s Center for Drug Evaluation and Research (CDER) lays out 2021 agenda.

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) released a list of the new and revised draft guidances it plans to release in 2021. In total, there are 105 guidances included on the agenda, 42 of which are new for 2021. This year there are four new categories of draft guidances that appear on the agenda that were not included in 2020: animal rule, biosimilars, compounding and pharmacology/toxicology.

Public consultation open for EMA's Guidelines on good pharmacovigilance practices (GVP) - Module XVI - Risk minimisation measures: selection of tools and effectiveness indicators (Rev 3)

Revision 3 includes, among other updates, the clarification of the role of risk minimisation for risk management planning and for the impact on the risk-benefit balance of medicinal products, and the role of effectiveness evaluation of risk minimisation measures, and to delete/merge. It also gives more guidance about the criteria for applying/requesting additional risk minimisation measures; to give more details on the role of healthcare professionals and patients and to clarify possible strategies for their early engagement and role in risk minimisation development, dissemination and evaluation.

Public consultation open for EMA's Guidelines on good pharmacovigilance practices (GVP) - Module XVI Addendum II – Methods for effectiveness evaluation

This Addendum to GVP Module XVI provides additional guidance for marketing authorisation holders and competent authorities on data sources and methodologies for monitoring outcomes of risk minimisation measures (RMM) in line with the principles for RMM effectiveness evaluation laid down in GVP Module XVI. Depending on the risk minimisation objective, studies evaluating RMM effectiveness may integrate different quantitative measurements and qualitative research approaches to evaluate risk minimisation outcomes for individual tools or sets of RMM described in GVP Module XVI.