EU and US complete GMP harmonisation process

The FDA and EMA have completed implementation of their mutual recognition agreement for GMP inspection, with Slovakia being recognised by the FDA.

The mutual recognition agreement means that the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) consider each others’ inspection processes to be equivalent.

This means that when a manufacturing site or product is inspected by the FDA, or a recognised EU national national competent authority such as the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), a certification for Good Manufacturing Practice (GMP) from one agency will be accepted by all.

The FDA’s recognition of Slovakia’s drug safety inspection processes marks the final step in implementing the agreement. This follows its recent recognition of Germany, Luxembourg and the Netherlands, and recognition of Portugal last year.

A mutual recognition deal was first announced at the political level in 1998, but talks on implementation only started in 2014, with a formalised agreement signed in November 2017.

The EMA announcement can be found here.

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Published on 23. July 2019 in News, News EU