17/18 May 2021
The European Medicines Agency EMA has published an updated set of questions and answers on the impact of Mutual Recognition Agreement (MRA) between the European Union (EU) and the United States (EMA/221696/2018). The new document addresses questions with GMP relevance. It doesn't add much new information but summarises some of the most important aspects.
Will inspections come to an end now?
The goal for sure is not to duplicate inspections. That means that FDA would not inspect a facility within the EU which has been inspected by an EU competent authority and vice versa. However, both the EU and FDA "reserve the right to inspect in each other's territory at any time"!
What about inspections in third countries?
There will be at least an option to rely on inspection reports of other inspectorates.
When will all EU Member States and their inspectorates be recognised by FDA?
The next milestone is 01 December 2018 for FDA "to confirm capability of a further six Member States". The plan is that all EU Member States are included by 15 July 2019.
Other questions and answers discuss topics like scope of the agreement, combination products and import testing. For more details please also see the Questions & Answers on the impact of Mutual Recognition Agreement between the European Union and the United States as of 1 June 2018.