In March 2017, it was a historical month, not just for pharmaceutical industry but for the United States of America and the European Union. The amended mutual recognition agreement (MRA) on “Pharmaceutical Good Manufacturing Practices” between the EU and the US was signed. The best outcome is that it could significantly reduce inspection pressure of the FDA EU inspectorates and we might be done with the re-testing of imported batches and batch certification. There is hope that this amended MRA will be implemented and history doesn’t repeat itself.

What is the Mutual Recognition Agreement?

A mutual recognition agreement is a bilateral trading agreement to facilitate trading between nations or regions. The MRA facilitates market access while safeguarding consumer health, mutual acceptance of reports and certificates, the exchange of information, and it encourages harmonisation. An MRA covers various economic sectors including Pharmaceutical Good Manufacturing Practices. The sectoral annex of “Pharmaceutical Good Manufacturing Practices” mentions the following.

– Recognition of GMP regulation, exchange of reports of inspections of manufacturers, the possibility to rely on foreign test results for batch release and the so-called re-testing.

EU-US Mutual Recognition Agreement

Amended MRA between EU and US 2017:

The signed amended MRA is a big achievement. Although this MRA has the potential to cut costs for (bio) pharmaceutical companies, it still contains a lot of terms and conditions. The terms and conditions contain aspects such as an FDA assessment of the EU member states, an EU assessment of the FDA and not all products are included in the Annex. Depending on these terms and conditions, parts of the MRA will come into force on time.

The FDA intends to complete all the 28 (27 after March 2019 depending on Brexit negotiations) full assessments by the 15th of July 2019. After these assessments are all completed, re-testing of imported batches and batch certification is no longer required. Until that moment, each imported batch and batch to be certified needs to re-tested. The fact that delivery of the capability assessment packages and their assessments are already planned and documented in the MRA, provides confidence that these milestones will be achieved.

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