International Regulators Collaborate on Regulatory Approaches During COVID-19

12 May 2020

BioPharm International

A high-level meeting on COVID-19 policies, organized by the European Medicines Agency (EMA) under the auspice of the International Coalition of Medicines Regulatory Authorities (ICMRA), has brought together global regulators to ensure a coordinated pandemic response. Details of the meeting were reported In a May 5, 2020 press release, issued by EMA. 

International regulators involved in the meeting discussed strategic issues and regulatory approaches to the pandemic, stressing the need for alignment on pre- and post-authorization regulatory requirements to enable rapid development, evaluation, and availability of COVID-19 treatments. Concerns around the small sizes of clinical trials were raised and the need for the development of priority criteria for planned trials was highlighted, during the meeting.

Additionally, calls for the inclusion of vulnerable or neglected populations in COVID-19 studies were made at the meeting. Alignment on common study protocols was a point reiterated by those involved in the meeting as a crucial aspect to ensuring trial results meet regulatory requirements and all evidence to be used in support of medicine or vaccine approval.

Regulators also discussed the development, evaluation, and use of diagnostic tests in the pandemic with those involved sharing insights into diagnostic accuracy and reliability of serological tests for COVID-19 that had been used in different countries. It was agreed upon that, along with the World Health Organization, an ICMRA inventory of diagnostic tests that are approved for use would be created. Through this inventory, it should be possible to assure comparability of results across different countries and will facilitate the alignment of regulatory approaches.

More detailed information about the meeting highlights can be found on EMA’s website.

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