13/14 March 2024
A possible agreement between the European Medicines Agency EMA and the US Food and Drug Administration FDA on mutual recognition of drug facility inspections is part of the Transatlantic Trade and Investment Partnership (TTIP). The idea was to have the agreement signed already in January 2017. This was 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 currently, with the election of Donald Trump as the next president of the USA, TTIP will have a rather low chance for implementation. The rejection of free trade agreements was a central message during Trumps' election campaign. The conversations about TTIP have currently entered a kind of rest phase.
Nevertheless the MRA was also discussed at the 84th GMP/GDP Inspectors Working Group with Interested Parties at the European Medicines Agency (EMA) on 23 November 2016. Like every year, the European QP Association was also invited to attend this meeting. At the last meeting, EQPA was represented by Dr Afshin Hosseiny, who is also Co-Chairman of the ECA Executive Board. During the meeting it was pointed that EU is still aiming to sign off the agreement, although there was some concern that the new administration may decide to change it or cancel altogether. If signed, there will be a transition period for the implementation. US FDA still wants to satisfy itself on each member state. "It is not clear how this is going to be achieved, but import testing will be part of the negotiations." Dr Hosseiny says. This could possibly mean that not all member states are approved at the same time, which is not really going to fit with the EU philosophy. It is worth to mention that the agreement will not include import testing; so any imported product from USA has to be retested in EU before release. "It is a goal to include import testing, but it is not clear when that can be implemented".
It is important to mention in this context that there has been an "Agreement on Mutual Recognition between the European Community and the United States of America" signed on 4.2.1999, with a chapter 6 on "Pharmaceutical Good Manufacturing Practices (GMPs)". This MRA included a three-year transition period in which the US FDA wanted to satisfy itself on each Member State's inspection practice. After performing several mutual inspections, the FDA made proposal to have the MRA limited to only some Member States. This was not acceptable for the EU. So the MRA never became effective.
And what does FDA think? In a presentation given by Janet Woodcock (Director CDER) at the FDA/CMS Summit on 14 December in Washington, she said that "Negotiating, with Global Operations Office, a Mutual Reliance Agreement with Europe on facility GMP inspections" is still on the programme.