EU-US mutual recognition agreement now includes Portugal

Various select EU nations are now able to carry out recognised good manufacturing process (GMP) inspections at the standard required by the Food and Drug Administration (FDA) in the United States. Portugal was added to this group of countries in September 2018, bringing the total to 15. The EMA is also able to carry out these inspections.

The reciprocal agreement also means that the FDA is able to carry out EU-standard GMP inspections on behalf of the EU. Together, these arrangements should enable cost and time savings for companies trading across the Atlantic. Plans are in progress for all EU member states to be added to the agreement by 15 July 2019.

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Published on 21. September 2018 in News, News EU