The U.S. Food and Drug Administration (FDA) and the E.U. European Medicines Agency (EMA) announced that Slovakia has beeen added to a mutual recognition agreement (MRA) regarding good manufacturing practice (GMP) inspections in the European Union. Slovakia was the last of the 28 member states of the European Union to be recognized as capable of conducting manufacturing facility inspections which meet FDA requirements. The MRA allows the FDA and the EMA to use inspection reports and other related information obtained by the other agency during manufacturing facility inspections. Either agency can require additional inspections or other actions as necessary to protect the public. The recognition of European drug regulatory authorities as capable of conducting inspections which meet FDA requirements is part of the implementation of the amended Pharmaceutical Annex to the 1998 U.S. – E.U. MRA.
Medicinal products approved for use in the U.S. can be manufactured or contain ingredients manufactured in other countries. Since all drugs approved in the U.S. must comply with U.S. regulations, FDA inspects both foreign and domestic manufacturing facilities on a regular basis. Prior to implementation of the MRA, both the FDA and the EMA conducted inspections of the same manufacturing facilities and pharmaceutical companies were required to carry out batch testing for products imported into the U.S. even though similar testing had already been carried out in other countries. The full implementation of the MRA will avoid duplication of facility inspections in Europe and the U.S. which will allow the agencies to direct more resources to inspections in other countries. In addition, costs should be reduced for pharmaceutical manufacturers since batch testing for products imported into the U.S. will be waived when such testing has been carried out in a member state of the European Union.
Human drugs and biologics are encompassed by the MRA , however, specified products are still being assessed. Veterinary medicines are still being assessed with a decision expected by December 15, 2019. A decision regarding human vaccines and plasma derived medicines is expected by July 15, 2022; and a decision on products intended for use in clinical trials is expected to be made at an unspecified date in the future. Products which are excluded from the MRA include human blood and plasma, human tissues and organs, veterinary immunologicals and medicines based on genes, cells or tissue engineering.
The MRA will facilitate market access, encourage harmonization of compliance standards, reduce duplication of inspections and reduce costs by waiving re-testing of products upon importation.