EMA and FDA agree new priorities, including research on COVID-19

INICIO/Políticas y legislación | Posted 10/07/2020 post-comment0 Post your comment

At the 2020 bilateral regulatory dialogue meeting, senior officials from the European Commission, European Medicines Agency (EMA) and US Food and Drug Administration (FDA) identified new strategic priorities for medicines.

Shaking hands V13D29

The meeting, which was hosted virtually on 18 and 19 June 2020, was attended by senior officials from the European Commission Directorate General for Health and Food Safety (EC DG SANTE), EMA and FDA.

The meeting marks 17 years since the formal start of the collaboration between EMA and FDA. Frequent interactions between the two agencies aim to align and advance their scientific and regulatory work.

The meeting included a review of existing initiatives, discussion of areas where collaboration can be improved, and identification of new strategic priorities for the future.

Much of the discussion of course focused on the COVID-19 pandemic, as a result of which the EC, EMA and FDA have intensified their collaborations via the International Coalition of Medicines Regulatory Authorities (ICMRA).

Highlights from the discussion were presented by an article recently published by EMA.

Topics of discussion related to COVID-19 included:

  • Vaccines: The agencies agreed to share their experiences in facilitating the development and review of vaccines against SARS-CoV-2.
  • Observational research: They agreed to collaborate on observational research on COVID-19 (specifically on vaccine surveillance, building international cohorts, and use of medicines in pregnant women with COVID-19). This will serve as a model for the use of real-world evidence to support regulatory decisions, with EMA and FDA agreeing to jointly develop a roadmap for international collaboration on real-world evidence.

Other topics of discussion included:

  • Personalized therapies for rare diseases: The agencies discussed the scientific and regulatory challenges of individualized therapies for ultra-rare diseases, such as gene therapies.
  • Mutual recognition agreement (MRA) for good manufacturing practice (GMP) inspections: In 2019, FDA and EMA signed an MRA meaning that GMP inspections carried out in the EU are recognized in the US, and vice versa [1]. At the latest meeting, the agencies discussed expanding the MRA to veterinary medicines as well as vaccine and plasma-derived products like antibodies. A preliminary deadline for this has been set of July 2022.
  • Orphan medicines: The agencies discussed information sharing initiatives and cooperating on data analysis for the characterization of rare diseases.

Related articles
FDA sets up centre to improve quality of compounded drugs

FDA’s global inspection strategy strengthened

IPRP expands and all EU Member States now included in EU-US MRA

1. GaBI Online - Generics and Biosimilars Initiative. US and EU sign milestone mutual recognition agreement [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 10]. Available from: www.gabionline.net/Policies-Legislation/US-and-EU-sign-milestone-mutual-recognition-agreement

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing. 

Copyright – Unless otherwise stated all contents of this website are © 2020 Pro Pharma Communications International. All Rights Reserved.

Source: EMA

comment icon Comments (0)
Post your comment
Related content
FDA publishes final Q&A on biosimilar development and the BPCI Act
INICIO/Políticas y legislación Posted 15/10/2021
FDA voices concerns around drug patents and competition
Patent 1 V13E17
INICIO/Políticas y legislación Posted 08/10/2021
USA BIOSIM Act introduction
02 AA010638
INICIO/Políticas y legislación Posted 17/09/2021
Most viewed articles
Sobre GaBI
INICIO/Sobre GaBI Posted 05/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
INICIO/Directrices Posted 08/10/2010