MRA: Can Import Testing be completely stopped now?

Recommendation

13/14 December 2023
Berlin, Germany

Root Cause Analysis
A CAPA Workshop on Successful Failure Investigation

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:

• Testing was carried out in the United States of America
• The product was manufactured in the United States
• Each batch comes with a batch certificate (in accordance with the WHO certification system)
• This batch certificate has been issued by the manufacturer and certifies that the product complies with the requirements of the marketing authorisation.
• The batch certificate is signed by the person responsible for releasing the batch (in USA).

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).