On November 1, 2017, the EU-U.S. agreement on the recognition of inspections of human drug manufacturing sites in their respective territories came into force. This agreement reinforces the dependence on each other`s expertise and resources in terms of inspection. It originally applied between the FDA and EU Member States, which had been reviewed by the FDA. This has been gradually extended to all EU Member States. Similarly, the EU evaluated its counterpart in the United States and, in June 2017, concluded that the FDA had the capacity, capacity and procedures to conduct GMP inspections for drugs for human use at a level equivalent to that of the EU. With the recognition of Slovakia by the U.S. Food and Drug Administration (FDA), the European Union and the United States have fully implemented the Mutual Recognition Agreement (MRA) for the inspection of the production sites of certain drugs for human use on their respective territories. 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, pending further reflections: 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. We certainly agree that there is a need for more data on the MRA us/EU, beyond the operational data we are currently collecting. In fact, we are working with our EU partners to look at what additional measures might be instructive.

With sufficient data, the FDA will decide how we assume not only our inspection resources, but also the extent and scope of future mutual recognition and mutual trust agreements that could include other categories of inspections and types of products such as veterinary drugs. Since these other categories in Europe often involve different inspections than those tested for drugs for human use, implementation may take some time. Finally, with the necessary measures, we could also confirm its usefulness, so that manufacturers can avoid unnecessary inspections while ensuring that the drugs are safer for patients. Based on the expertise and ability of the other to conduct GMP inspections as part of the annex to the UE/Ue Mutual Recognition Agreement, we expected that inspections of the same facilities would be doubly avoided, particularly in the case of facilities with a strong compliance record. And these efficiency gains would allow us to redeploy our inspection resources to more risky areas. Of course, we knew that we had to wait for the agreement to be implemented before we could confirm these assumptions. 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. 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.

The transition period for medicines for human use, which is covered by the agreement, ended on 11 July 2019: we await the final decision on whether or not to include veterinary medicines in the scope of the mutual recognition agreement currently concluded between the European Community (EU) and the United States, which allows recognition of GMP inspections from other Member States.