FDA and EU Finish cGMP Inspection Integration
[Thursday, July 18, 2019]

As of last week, FDA has fully implemented its Mutual Recognition Agreement (MRA) with the European Union (EU) whereby FDA and regulators from all 28 member countries of the EU would share GMP inspection findings at drug manufacturing sites. The MRA is but the first step to integrating GMP audits across various regulators to avoid duplicative inspections and freeing resources to go after major offenders. GMP inspections, commonly called GMP audits, are an essential responsibility of regulators. In these audits, regulators perform a detailed on-site review of the quality systems at the inspected site to evaluate its compliance with the requirements. These activities take time and efforts; and hence each year regulators can audit only a fraction of the registered manufacturing sites. Since most regulators look for similar things, it seems like an easy solution to share resources to limit duplicative inspections. The MRA provides some benefits and some limitations, at least for the near future. The benefits are obvious; regulators in the EU countries and FDA would share inspection findings. FDA will share findings from US manufacturing sites exporting to EU countries, and the EU regulators would share findings from sites located in their respective countries exporting to the US. The EU regulators do not need to share findings from their audits of US-located sites and vice versa for the FDA, however, it is expected that cross-country audits by regulators will be fewer and only focused on seriously non-compliant facilities. At present the MRA applies only to drug manufacturing sites only, not biologics or medical devices. Also, at present the regulators do not intend on sharing their findings from regulators on regions outside the US and EU. In its announcement, FDA indicated that it plans to expand this agreement to biologics and medical devices, and to audits conducted in other regions. This first step to global inspection harmonization starts in a safe location as both US and EU located sites generally have had better compliance records compared to those located in other regions. This would help regulators train in sharing information which in turn would help later expand into other regions. This also would free resources now to increase inspections in other regions.