EU-FDA MRA to be expanded

Recommendation

15/16 February 2022

Combination Products - Live Online Training

It has not yet been fully implemented - and we are already talking about an enlargement. The Mutual Recognition Agreement (MRA) with the USA was extended in 2018 to include further countries: Czech Republic, Greece, Hungary, Romania, Ireland, Lithuania, Portugal, Belgium, Denmark, Estonia, Finland, Latvia. Some countries, including Germany, are still not part of the agreement. (Here you will find an overview of the current status). By 15 July 2019, however, all authorities and countries should have been approved and included.

Now, there are already discussions about extending the scope of the MRA. It is to be extended to veterinary medicinal products in the medium term. Later, until 2022, the MRA is to be extended to include joint inspections of production facilities for human vaccines and plasma derivatives. An action plan will be drawn up for this purpose in 2019. This is stated in an interim report of the Executive Working Group EWG.