Marco Righi -

Mutual Recognition Agreements (MRAs) are internationally binding agreements between countries that aim to facilitate market access and optimize the use of resources for both regulators and the pharmaceutical industry, resources that can be better invested on medical innovation.  This is particularly relevant for SMEs where duplicative site inspections impose proportionately greater burdens.

The US Food and Drug Administration (FDA) already has MRAs in place with the European Union (EU) and one with the United Kingdom (UK) while Swiss Agency for Therapeutic Products (Swissmedic) has an MRA in place with UK, EU, Canada and South Korea.

On January 12th, 2023, US FDA and Swissmedic signed an MRA of good manufacturing practice for medicinal products including veterinary drugs. As for other MRA dealing with GMP, before the agreement enters into force, the FDA must determine whether Swissmedic is capable of conducting inspections that meet U.S. requirements, and Swissmedic must make a similar determination with respect to the FDA meeting Swiss requirements.

Upon entry into force, this agreement allows FDA and Swissmedic to share documents from their routine GMP inspections of pharmaceutical manufacturing facilities leading to the reduction of unnecessary costs and duplicative efforts.

Regulatory Pharma Net (RPN) can provide support in preparation of GMP inspection readiness by undertaking gap analysis and GMP audit prior to the inspection by the regulatory agency. RPN can also assist you in the preparation and implementation of the relevant CAPA plan.

Comments are closed for this post.