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16.11.2016

EMA/ FDA Mutual Recognition Agreement moving forward

Recommendation

2/3 September 2026
Copenhagen, Denmark

Root Cause Analysis
When “Human Error” isn’t enough: Successful Failure Investigation

A possible agreement between the European Medicines Agency EMA and the US Food and Drug Administration FDA on mutual recognition of drug facility inspections could already be signed in January 2017. This is noted in a report of the EU Commission: "The state-of-play and the organisation of the evaluation of the US and the EU GMP inspectorates were discussed. In light of the progress achieved, the conclusion of a mutual recognition agreement of Good Manufacturing Practices (GMPs) inspections by January 2017 is under consideration."

But, according to the Commission, some issues are still not resolved - like, for example, the exchange of confidential information and the inclusion of veterinary products in the scope of the text.

The "Report of the 15th Round of Negotations for the Transatlantic Trade and Invesment Partnership" summaries the 15th round of negotiations for the Transatlantic Trade and Investment Partnership (TTIP) from 3rd to 7th October 2016 in New York.