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Understanding Mutual Recognition Agreements and Their Role in QP Release of Medicinal Products.

What Is an MRA?

An MRA is a formal agreement between the EU and a third country to mutually recognize Good Manufacturing Practices (GMP) inspections and batch certifications of both human and veterinary medicinal products. These agreements are typically based on an evaluation of regulatory equivalence and mutual trust in enforcement systems.

The EU has MRAs with several countries, including the United States, Canada, Japan, Australia, Switzerland, and others. These can be found on the following website of the European Medicines Agency: Mutual recognition agreements (MRA) | European Medicines Agency (EMA).

The Role of the Qualified Person (QP)

Under Directive 2001/83/EC, a medicinal product cannot be released for sale or supply in the EU unless a QP certifies that each batch has been manufactured and checked in accordance with EU GMP, the terms of the marketing authorization (MA) and the law in force in the member state (refer to EU GMP annex 16: Certification by a Qualified Person and Batch Release).

MRA and QP Release: How Are They Connected?

Under normal circumstances, a QP must ensure that manufacturing and quality control testing have been performed at an EU-GMP certified site, including for imported products. However, when an MRA is in place between the EU and the exporting country, the QP is permitted to rely on the GMP certificate issued by the regulatory authority of that country, rather than requiring re-inspection or testing within the EU. This results in some practical implications:

• Reduced Retesting: Products imported from MRA countries generally do not require repeat QC testing upon EU import, as the testing done in the MRA country is accepted as equivalent. The QP can thus use the GMP documentation from the MRA supplier to certify a batch without duplicative tests, provided they have sufficient assurance of compliance.

• Supply Chain Efficiency: This significantly shortens lead times and reduces costs.

However, despite the benefits, MRAs do not remove the responsibility of the EU QP. Moreover, MRAs may have scope limitations, such as excluding certain product types (e.g., biologics, investigational medicinal products). For example,

• The EU-Australia MRA excludes the advanced therapy medicinal products.
• The EU–US MRA does currently not include vaccines for human use and plasma-derived products.

All up to date information can be found on the EMA website: Mutual recognition agreements (MRA) | European Medicines Agency (EMA)

Conclusion

Mutual Recognition Agreements are a strategic tool that enhances regulatory cooperation and global supply chain efficiency. In the EU, they provide essential support for the QP in fulfilling their responsibilities.

However, the EU QP remains the gatekeeper for product release in the EU. MRA or not, their due diligence, professional judgment, and adherence to GMP remain indispensable in safeguarding the quality of medicines across Europe.

By Kelsey Frederickx