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  • 13. Dezember 2020

    Mutual Recognition Agreement Between Eu And Us

    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. Luxembourg and the Netherlands were included in the eu-EU-FDA mutual recognition agreement in the United States. Trade agreements are trade agreements designed to facilitate market access and promote greater international harmonization of compliance standards while protecting consumer safety. 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 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. 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. Measures to implement the MRA agreement are progressing in all EU member states. The scheduled date is July 15, 2019. In 2017, the MRA has been suspended and incorporated into the EU-Canada Comprehensive Economic and Trade Agreement (CETA), which will come into force from September 2017.

    The suspended MRI will end with CETA coming into force until it is ratified by EU member states. Differences of opinion on the effectiveness of the proposed new treatments were the main causes of divergence in final licensing decisions on both sides of the Atlantic. Some differences were also observed in the evaluation of clinical data, often due to the difference in the date of their submission: in general, applications were submitted to the FDA at trial and subsequent use at the EMA may include data from additional clinical trials or, particularly for oncology drugs, more mature data from the same clinical trial.


    Verfasst von Stefan Oberhauser

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    Veröffentlicht in Allgemein

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