EC: EMA and US FDA GMP inspection deal could be agreed by January

The European Commission made the comments in a report​ on the 15^th​ round of negotiations of the proposed Transatlantic Trade and Investment Partnership (TTIP) which were conducted in New York earlier this month.

According to the 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. ​

The EC cautioned, however, that a number of matters still to be agreed discussed, notably the scope of the information exchange and whether confidential information about manufacturing processes will be exchanged.

Background​

EU officials put forward the idea that US regulators could accept good manufacturing practice (GMP) compliance certificates issued by the EMA and vice versa in April​. The rationale was to eliminate duplicate inspections of active pharmaceutical ingredient (API) and drug manufacturing plants.

They EU also suggested certificates issued to manufacturing facilities outside Europe and the US could be accepted as proof a plant is up to code by the issuing regulator’s counterpart on the opposite side of the Atlantic.

To facilitate such mutual recognition the EU team suggested EMA and FDA drug approval requirements should be more closely aligned – everything from preclinical testing through to production – adding that guidelines would need to be developed in collaboration.