New Version of the Q&A Catalogue published
On the Road to 30,000 Members
Let us become the World's Leading GMP/GDP Compliance Community in 2026
Again, the question and answer catalogue "QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC" of the Heads of Medicines Agencies (HMA), European Medicines Agency (EMA) and the European Commission (EC) has been extended and updated. This third version additionally lists points 4.2-4.4 and includes an update of point 2.2.
The question and answer catalogue provides instructions on the current handling of marketing authorisation procedures and existing marketing authorisations and informs about the handling of variation procedures or marketing authorisation renewals. Additional guidance and practical approaches to these issues can be found in the "Practical guidance of the CMDh for facilitating the handling of processes during the COVID-19 crisis".
Here, you will find the latest version of the "QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC" and the corresponding explanations of "Practical guidance of the CMDh for facilitating the handling of processes during the COVID-19 crisis".
Related GMP News
21.10.2026EMA Clarifies ESMP Reporting for Critical Medicine Shortages
20.10.2026EDQM Updates Guidance on CEP Sister File Applications
20.10.2026EDQM Revises Guidance on Electronic Submissions for CEP Applications
14.10.2026Bioassays in the United States Pharmacopoeia - Two Chapters come into Force in Spring
07.10.2026CEP 2.0: EDQM Updates Guidance on the Use of Certificates of Suitability
23.09.2026IRIS Portal: EMA expands digital Procedure Management