TTIP: The End of FDA Inspections in Europe?

Recommendation

5/6 October 2023
Heidelberg, Germany

Quality Culture
People Empowerment in GMP

Would the implementation of the Transatlantic Trade and Partnership (TTIP) programme bring an end to FDA inspections in the EU and vice versa? There might a chance according the EU proposal for a respective annex on medicinal products. The European Union's proposal for an annex on medicinal products was published on 24 May 2016. It was tabled for discussion with the US in the negotiating round from 25-29 April 2016. However, a final text will be a result of negotiations between the EU and US and implemented in a final agreement.

In Article 7 of the document, EU proposes that. "A Party shall accept a certificate of Good Manufacturing Practice (GMP) compliance issued by a competent authority of the other Party, as demonstrating that the manufacturing facility that is covered by the certificate and located in the territory of that Party complies with GMP." Further details to this should be defined in the respective annex. But also inspections in third countries might be accepted and could reduce the workload of the competent authorities: "A Party may accept a certificate of GMP compliance issued by a competent authority of the other Party with respect to a manufacturing facility located outside the territory of any of the Parties."

This will be supported by the exchange of regulatory information between the Parties on Good Manufacturing Practice (GMP) inspections and GMP reports but also on information on GMP non-compliance, recalls, data integrity and risks of shortages of medicinal products (see Article 8).