Gmp Mutual Recognition Agreement

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  • Post published:February 21, 2022
  • Post Category:Uncategorized

Manufacturing companies from countries outside the EU and the US are seeing an increase in inspections under the US-EU MRA. Indeed, the EU and the US import a large proportion of APIs and finished medicines from countries outside the US. The agreement allows agencies on both sides to allocate their inspection resources to facilities that supply these APIs and finished drugs. In this way, with increased inspections, appropriate controls are carried out to improve the quality and safety of the products. In July 2018, President Juncker and Trump agreed on a joint declaration. This included a commitment by the EU and the US to remove barriers and increase trade in a number of sectors, including the pharmaceutical industry. An essential element of the Joint Declaration was provided with the implementation of the Mutual Recognition Agreement (MRA) for on-site inspections, when the last outstanding EU Member State was recognised by the US. Food and Drug Administration (FDA) of Slovakia on July 11, 2019. The European Union (EU) has signed Mutual Recognition Agreements (MRAs) with third country authorities on conformity assessment of regulated products. These agreements contain a sectoral annex on the mutual recognition of good manufacturing practice (GMP) inspections and the certification of batches of medicinal products for human and veterinary use. The EU and the US signed the MRA for products currently in scope for the first time on 1 November 2017, with eight EU countries immediately benefiting from the agreement.

After that date, there were many incremental approvals, with Ireland approved on 1 June 2018. All 28 EU countries are now included in the scope of this agreement. We await the final decision on the inclusion of veterinary medicinal products in the scope of the Mutual Recognition Agreement (MRA) currently in force between the European Community (EU) and the United States, which provides for the mutual recognition of GMP inspections. The application of the MRA is currently focused on the successful implementation of sections of the MRA that are relevant for GMP monitoring or routine inspections. Application-specific inspections, such as . B prior to approval, fall within the scope of the MRA; However, since these inspections are based on applications submitted to a particular regulatory authority, additional coordination and assessments are needed in the US and the EU. Current products under the agreement include finished medicines marketed for human consumption in various dosage forms such as tablets, capsules, ointments and injectables, marketed biologics, intermediates and active pharmaceutical ingredients (APIs). With this implementation, FDA and EU drug inspectors can use each other`s inspection data during inspections in each other`s countries. While this agreement helps to increase efficiency between the two agencies by avoiding redundant inspections, it also allows agencies to focus their resources on inspections of drug manufacturing facilities in other countries.

However, the deal also has implications for pharmaceutical companies. The transitional period for medicinal products for human use covered by the agreement ended on 11 October. July 2019: The MRA with Israel is an agreement on conformity assessment and acceptance of industrial products (ACAA). This is a specific type of MRA based on the alignment of the legal system and infrastructure of the country concerned with that of the EU. The Mutual Recognition Agreement (MRA) between the FDA and the European Union allows drug inspectors to rely on information from drug inspections conducted within each other`s limits. Under the Food and Drug Administration Safety and Innovation Act enacted in 2012, the FDA has the authority to enter into agreements to recognize drug inspections by foreign regulatory agencies if the FDA has determined that those agencies are capable of conducting inspections that meet U.S. requirements. The FDA and the EU have been working together since May 2014 to assess how they each inspect drug manufacturers and to assess the risks and benefits of mutual recognition of drug inspections. .