Fda Mutual Recognition Agreements

20 Sep 2021

40

Fda Mutual Recognition Agreements

When we first started discussing the prospects for a mutual recognition agreement with the European Union, in which eu member state regulatory authorities (EUMS) and the FDA would mutually agree on the factual results of their Good Practice Manufacturing (GMP) inspections of pharmaceutical establishments, the potential benefits seemed obvious. The need for these metrics was one of the recommendations of the National Academies of Sciences, Engineering and Medicine (NASM) in a recent report. The FDA had asked an ad hoc NASM committee to study mutual recognition and mutual trust agreements around the world (some date back many years) and the Committee found a surprising lack of data on the successes and challenges of these programs. In order to fill this information gap, the Committee invited regulatory authorities to put in place a results framework with clear indicators, measures and processes for monitoring and evaluating these programmes. According to the report`s authors, such information would improve understanding of the program`s public health benefits and allow for benefit and risk analyses over time. We certainly agree that we need more data on the US/EU MRA, on the operational data we are currently collecting. Indeed, we are working with our EU partners to determine what additional measures could be informative. Sufficient data will help the FDA decide not only how our inspection resources will be allocated, but also the scope and scope of future mutual recognition and mutual trust agreements, which could include other categories of inspections and product types, such as veterinary drugs. As these other categories in Europe often include different supervisory authorities than those tested for medicinal products for human use, implementation could take some time.

However, the available metrics have also allowed us to confirm their benefits, allowing manufacturers to avoid unnecessary inspections while ensuring that the drugs are safer for patients. With the recognition of Slovakia by the US Food and Drug Administration (FDA), the European Union and the United States have now fully implemented the MUTUAL Recognition Agreement (MRA) on inspections of production sites for certain medicinal products for human use in their respective territories. The MUTUAL Recognition Agreement (MRA) between the FDA and the European Union allows drug inspectors to rely on information from drug inspections conducted within the borders of the other country. Under the Food and Drug Administration Safety and Innovation Act, passed in 2012, the FDA has the authority to enter into agreements to recognize drug inspections by foreign regulatory authorities if the FDA finds that those authorities are able to conduct compliant inspections in the United States.