GMP News - Regulatory Affairs

The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) released a Q&A document to address challenges arising from the COVID-19 pandemic. The document is updated continuously and includes new Q&As relating to pharmacovigilance activities like CAPAs, Audits and Remote-Inspections.

In order to ensure a smooth and efficient cooperation between the authorities and marketing authorisation holders even in the times of Covid-19, the documentation and templates to facilitate the handling of marketing authorisations have now been bundled, listed and published on the website of the HMA (Heads of Medicines Agencies).

Emer Cooke from Ireland will be the new director of the European Medicines Agency (EMA) in Amsterdam. This was announced by the EMA Management Board.

Due to the corona pandemic, many processes and regulations are currently in change - information regarding the current procedures for applying for CEPs is listed on the EDQM website.

Again, the catalogue with "QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC" issued by the EC, HMA and EMA has been updated. It now includes the facilitated handling of existing marketing authorisations together with the handling of marketing authorisation procedures in times of Covid-19.

EMA´s Pharmacovigilance Inspectors Working Group adopted an new guideline on the follow-up activities of pharmacovigilance inspections.

On 10 April 2020, the European Medicines Agency (EMA) together with the Heads of Medicines Agencies (HMA) and the European Commission (EC) published a first version of the document "QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC", which is continuously updated and adapted.