During a transitional period, the authorities assess each other`s pharmaceutical legislation, guidelines and regulatory systems under the agreement. The agreement, initially announced in 2017, represents a three-year cooperation between the FDA and the EU and will allow all partners to recognise inspections carried out by each other. Luxembourg and the Netherlands were included in the eu-EU-FDA mutual recognition agreement in the United States. The European Union (EU) has signed Mutual Recognition Agreements (MRA) with third-country authorities on the assessment of compliance of regulated products. These agreements contain a sectoral annex on mutual recognition of good manufacturing practice inspections (GMPs) and certification of batches of medicines for human and veterinary use. „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. Restrictions: Capacity determination applies to routine inspections. In the future, the following types of products and inspections may be included in the scope of the agreement: with the recognition of certain medicines for human use by the Food and Drug Administration of the United States of Slovakia, the European Union and the United States have fully implemented the Mutual Recognition Agreement (MRA) on inspections of manufacturing sites for certain medicines for human use on their respective territory. Trade agreements are trade agreements designed to facilitate market access and promote greater international harmonization of compliance standards while protecting consumer safety.
One of the main benefits that the agreement will bring to European companies is the abandonment of batch testing for the importation of medicines from the United States. In the EU, the qualified person (PQ) is relieved of his responsibility for carrying out the checks in accordance with Article 22, paragraph 1, paragraph b), directives 75/319/EEC of the Council, provided these checks have been carried out in the United States. Each lot must also be accompanied by a lot certificate issued by the manufacturer and signed by the person responsible for the release of the lot. EMA: www.ema.europa.eu/en/documents/other/questions-answers-impact-mutual-recognition-agreement-between-european-union-united-states-11-july_en.pdf On 1 November 2017, the EU and the US first signed the MRA for current products, with eight EU countries benefiting immediately from the agreement. After that date, there were many progressive authorisations, with Ireland approved on 1 June 2018. The 28 EU countries are now included in the scope of this agreement. Measures to implement the MRA agreement are progressing in all EU member states. The scheduled response date is July 15, 2019. The scope and relevance of ARM is 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 by pharmaceutical companies of rigorous good manufacturing practices 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. The MRA with Israel is an agreement on the evaluation of compliance and acceptance of industrial products (ACAA).
It is a specific type of MRI based on the alignment of the legal system and infrastructure of the country concerned with that of the EU.