It took the US Food and Drug Administration (FDA) 5 years to complete capability assessments of the 28 EU Member States under a transatlantic Mutual Recognition Agreement (MRA) for pharmaceuticals. With the FDA’s recognition of Slovakia on Thursday, 11 July, this has been done: all regulatory authorities of the Twenty-Eight are now recognised by the FDA - which has been reciprocal since June 2017 when the EU determined the same about the FDA.
Rather than having to carry out their own inspections, European and US authorities can now rely on the results of their partners' inspections, linked to the "Good Manufacturing Practices" (GMP) of drug manufacturing sites for human use.
The MRA applies, at this stage, only to surveillance inspections conducted in the respective territories of the parties; however, the parties may choose to extend it to manufacturing facilities located outside their respective territories, according to a press release from the FDA. The agreement could also include, in the future, other regulated products, such as veterinary medicines, human vaccines and plasma derived medicinal products.
For Léa Auffret, commercial expert for the European Consumer Organisation (BEUC), "mutual recognition of EU and US inspections of company facilities avoids duplicating these inspections. This should lead to a more effective use of resources, while preserving consumer safety"; she also recalled the importance of "high inspection standards".
Progress on the positive agenda
The Commission also welcomed the fact that this agreement marks a new step in the implementation of the 'positive' agenda between the EU and the United States (see EUROPE 12071/2), despite the lack of progress in trade negotiations (see EUROPE 12258/14).
For BEUC, this agreement demonstrates "that EU and US regulators can improve transatlantic cooperation without this cooperation being decided through trade negotiations", Léa Auffret stressed. (Original version in French by Hermine Donceel)