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

By Gareth Macdonald contact

- Last updated on GMT

iStock/AlexLMX
iStock/AlexLMX

Related tags: European union, European commission, International trade, Us

Development of an EMA and US FDA mutual recognition agreement on drug facility inspections has progressed according to European Commission negotiators who say a deal could be signed by January.

The European Commission made the comments in a report​ on the 15th​ 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.

What is TTIP?

The Transatlantic Trade and Investment Partnership is a free trade agreement being negotiated between the EU and US.  It will open up their export markets, eliminating all tariffs and other barriers on trade for pharmaceuticals, among other products.

It will also standardise many regulations, and – a sticking point for many dissenters – enforce very strong IP protection.

15 rounds of negotiation have taken place so far, with implementation expected by the end of the year

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.

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