USA and EU adopt Mutual Recognition Agreement - Does it mean the End of FDA Inspections in Europe?

On 2nd March 2017, the US FDA and the EU (EMA) informed that they concluded a so-called MRA (Mutual Recognition Agreement). Such agreements are intended to mutually recognize GMP inspection systems. As a consequence, the GMP Compliance of a site is reviewed by the respective inspection authority. Afterwards, the FDA can use EU inspection results and vice-versa. FDA inspections in the EU or EU inspections in the USA should be only performed in exceptional cases.

The EU has already concluded MRAs with other countries like Australia, Canada, Japan, Switzerland and New Zealand. The MRA with the USA has already been under discussion since the nineties. In 1998, a contract was made but never put into practice, though, because of the two very different legal systems. The question of communicating detailed inspection results has been a recurring subject of discussions. Moreover, the FDA had doubts about the consistent quality of inspections in Europe. Equivalent systems had been recognised for some countries but it had also been noticed that some EU countries couldn't show an inspection system comparable to that of the FDA. Yet, the EU has consistently made clear that the agreement could only be concluded with the EU and not with individual EU member states.

In the context of negotiations over the last years, progress has been made with regard to those points. Since 2014, cooperation has been intensified. Thereby, a Joint Audit Programme has been established. So far, the FDA has participated as an observer in 13 audits performed among EU countries. During the first audit of this kind, inspectors from England and Norway audited the Swedish GMP inspectorate under FDA supervision.

It will be interesting to see how the procedural rules are concretely applied in case of suspension of recognition of an authority - e.g. when the FDA refuses to recognise the inspection authority of an EU country and vice-versa. Article 13 specifies that. According to it, "Each Party has the right to suspend recognition of a recognized authority of the other Party. This right shall be exercised in an objective and reasoned manner and communicated in writing to the other Party and the recognized authority." [...] Furthermore: "Upon the suspension of an authority previously listed as a recognized authority, a Party is no longer obligated to accept official GMPs documents of the suspended authority."

The agreement which has been made shall cover both medicinal products and APIs. Human blood, human plasma, human tissues and organs, and veterinary immunologicals are excluded from the scope of the agreement. The new agreement should come into force on 1st November 2017. Until then, the FDA wants to review the authorities of further EU countries. Similarly, the EU wants to check the regulatory authorities in the different US Federal States.

Please also read the EU/EMA's press release as well as the FDA's news release.

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