13/14 December 2023
With the recognition of Slovakia on 11 July 2019, all EU member states are now part of the MRA (Mutual Recognition Agreement). The FDA was already recognised by the EU in 2017. The main objective was to mutually accept the respective GMP inspection systems and to reduce the number of foreign inspections. Another part that will provide relief is the elimination of additional full batch testing of human medicines imported from the USA. A QP can now refer to the release documentation and the decision of a US quality organisation for batch certification. However, in order to fully accept or adopt the test results, a few basic requirements must be met, which are also mentioned in Article 9 of the MRA document and the current Question and Answer document:
Here, the Qualified Person (QP) must make sure in advance that these points are met.
It is also important to assess the effects on the marketing authorisation. It must be ensured that the tests carried out in the USA fully comply with the marketing authorisation in the EU (e.g. methods, limits, testing and releasing site, etc.) - a corresponding change control process is indispensable here. In addition, existing Quality Agreements should be adapted and qualification steps for the testing site should be completed (incl. audit).