Offer extended until 31 July 2026: get a 10% early-bird discount on all events starting on or after 25 August 2026. To the promotion
GMP search engine – look up GMP compliance regulations and news
Covid-19: Handling of Marketing Authorisations
Recommendation
6/7 October 2026
On the Road to 30,000 Members
Let us become the World's Leading GMP/GDP Compliance Community in 2026
The processes and procedures relating to marketing authorisations are still strongly influenced by the corona pandemic. On the website of the HMA (Heads of Medicines Agencies) this has been reiterated and the available templates and information to facilitate and manage marketing authorisations and registration procedures have been consolidated and listed.
In addition to the continuously updated catalogue"QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC", the "Template for submission of an application for a Covid-19 exeptional change management process (ECMP)" and the "Template for Step 3 Notification of implementation" are available here.
The overview of the information provided and application templates can be found on the website of the HMA (Heads of Medicines Agencies) in the section CMDh.
Related GMP News
10.06.2026EDQM publishes revised CEP Guideline
27.05.2026What should you know about EU and US Drug Approval? Part 2
20.05.2026What should you know about EU and US drug approval? Part 1
18.03.2026ICH M4Q(R2): List of comments published
11.03.2026ASMF: CMDh updates Information on "Worksharing Procedure"