European Medicines Agency updates Reflection Paper on GMP Responsibilities of MAHs

On July 27, the European Medicines Agency (EMA) released a reflection paper on GMP and MAH, "Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders", which stipulates the GMP responsibilities of marketing authorization holders (MAHs) in accordance with the European Commission (EC) GMP guidelines and other EU legislation, and systematically sorts out the EU MAH regulatory system and corresponding GMP documents.

Specific document link: European Medicines Agency updates MAH and GMP regulatory system thinking document