Mutual Recognition Agreement Medicines

The EMA and FDA have been in negotiations since 1998 to conclude and approve a Mutual Recognition Agreement (MRA). The final MRA, approved in November 2017, was based on solid data from inspections carried out by participating countries within the European Union (EU) and members of the EMA and FDA. The data showed that testing procedures between agencies in good manufacturing practice inspections (GMPs) for drugs for human use were comparable. The final MRA was fully applicable on 12 July 2019 to inspections and batch certifications from 29 EU and US countries. The mutual recognition agreement allows the EMA and the FDA to optimize their inspection capacity and avoid the need for multi-agency inspections. This will allow patients to trust the safety, identity, strength, purity and quality of all drugs, regardless of where the products are manufactured or which agency has inspected the manufacturer. 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 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.

Work on the implementation of MRA will continue to extend the operational scope to veterinary drugs, human vaccines and plasma-based drugs. The transition period for medicines for human use, which is covered by the agreement, ended on 11 July 2019: in the coming months, the EU and the UK were to conclude an agreement ensuring the greatest regulatory harmonisation and cooperation in medicines for human use. Under previous agreements, a free trade agreement should also contain ambitious provisions on data exchange, intellectual property protection (IP), tariff facilitation and rules of origin (RoO). In accordance with the EU-South Korea Free Trade Agreement, the EU and the UK should set up a working group on medicines and medical devices. Veterinary drugs, vaccines for human use and plasma-based medicines are subject to transitional provisions. When we first discussed with the European Union the prospects of a mutual recognition agreement in which EU member state regulators (EUMS) and the FDA would agree to rely on the actual conclusions of their good manufacturing practices (GMPs) of pharmaceutical companies, the potential benefits seemed obvious. 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. The Mutual Recognition Agreement (MRA) between the FDA and the European Union allows drug inspectors to rely on information from anti-drug inspections carried out within the other country`s borders. Under the Drug Safety and Safety Act passed in 2012, the FDA has the authority to enter into agreements on the recognition of drug inspections by foreign regulators when the FDA has found that these authorities are able to conduct inspections that correspond to the United States.