Mutual Recognition Agreement Gmp

September 28, 2021

On 1 November 2017, the EU-US Agreement on the recognition of inspections of production sites of medicinal products for human use carried out in their respective territories entered into force. This agreement reinforces dependence on mutual inspection expertise and resources. Originally, the FDA and the EU Member States, which had evaluated the FDA, applied. This has been gradually extended to all EU Member States. Similarly, the EU assessed its counterpart in the US and concluded in June 2017 that the FDA had the capacity, capacity and procedures to carry out GMP inspections for medicinal products for human use at a level equivalent to that of the UNION. . . .