Eu-Fda Mutual Recognition Agreement (Mra)

EMA: The spectrum and relevance of ARM are easy to understand when you consider that 80% of the drugs marketed worldwide are produced either in the EU or in the United States, based on the adoption of good and rigorous manufacturing practices (GBUs) by pharmaceutical companies that regulate all stages of production processes. The implementation of the agreement on the sharing of the results of the BMP inspection is based on the assumption that the procedures applied by regulatory authorities (central or national) are also comparable. The provisions of the MRA have asked the FDA to carry out a formal evaluation of the procedures followed by each relevant European authority, an exercise that is coming to an end with Slovakia. During a transitional period, the authorities assess each other`s pharmaceutical legislation, guidelines and regulatory systems under the agreement. “We welcome the implementation of this agreement, which means that authorities on both sides of the Atlantic can now count on the results of each other`s inspections. This step is proof of the importance of our strategic partnership with the United States. It will make the most of our inspection capabilities so that patients can count on the quality, safety and effectiveness of all medicines, regardless of where they were manufactured,” said Guido Rasi, Executive Director of the EMA. Fear. Fear. Sleepless nights. Terror of disrespect. Do you remember the thoughts that crossed your mind when you heard that a regulator was going to inspect your facility? Then multiply that by 10, when you learned that not only are the members of the US FDA coming to inspect your facility, but that inspectors from one of the Member States of the European Medicines Agency (EMA) arrive for an inspection only a week after the fda ends. Breathe deeply, life is getting better! Finally, the implementation of a historic agreement between the FDA and the EMA means that these days are behind you.

The agreement does not currently apply to veterinary medicines, but the EU and FDA have agreed that veterinary drugs will be included by 15 December 2019 and discussions have already taken place between technical experts. Trade agreements are trade agreements designed to facilitate market access and promote greater international harmonization of compliance standards while protecting consumer safety. The transition period for medicines for human use, which falls under the agreement, ended on 11 July 2019: the agreement, initially announced in 2017, constitutes a three-year cooperation between the FDA and the EU and will allow all partners to recognise inspections carried out by each other.