Q&A paper of EMA, EC and HMA updated once again

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17/18 September 2024

Drug Master File Procedures in the EU, the US and Japan - Live Online Training
With updates on the CEP 2.0!

The questions and answers catalogue entitled "QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC", which was published for the first time in April 2020 by the European Medicines Agency (EMA) together with the Heads of Medicines Agencies (HMA) and the European Commission (EC), has now been updated and published again at the end of May. Beside information on GMP and GDP topics, it is intended to provide guidance for marketing authorisation holders with regard to regulatory options and adjustments in times of Covid-19. The questions and answers catalogue addresses topics on the current handling of marketing authorisation procedures and existing marketing authorisations and provides information on the handling of variation procedures or marketing authorisation renewals. Explanations and practical approaches related to these cases are detailed in the first revision of the "Practical guidance of the CMDh for facilitating the handling of processes during the COVID-19 crisis".

Find here the updated document "QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC" and the explanations of the "Practical guidance of the CMDh for facilitating the handling of processes during the COVID-19 crisis".