FDA-EMA complete historic mutual recognition agreement

15-Jul-2019 - Last updated on 15-Jul-2019 at 08:51 GMT

(Image: Getty/Sebastian Gorczowski)

Related tags Ema Fda Mutual recognition Japan Slovakia

The two regulatory agencies have confirmed the addition of the last country to their mutual recognition agreement, with GMP inspections by Slovakia given a positive assessment.

The announcement was made on Friday of last week, prior to the official deadline for the completion of the mutual recognition agreement, which had been set as today.

As a result of meeting the deadline, the US Food and Drug Administration (FDA) will now recognise the good manufacturing practice (GMP) inspections of all 28 member states of the European Union (EU).

The European Medicines Agency (EMA) had already arranged with the FDA that inspections carried out by the latter would not require re-inspection by the European authority.

After the completion of the mutual recognition agreement, the FDA can now also rely on inspections carried out by EU member states, reducing the inspection burden and “free[ing] up resources to inspect facilities in other countries,” the EMA suggested as part of its statement.

“This milestone is a testimony to the importance of our strategic partnership with the US. It will support making best use of our inspection capacity, so that patients can rely on the quality, safety and efficacy of all medicines, no matter where they have been manufactured,” said Guido Rasi, executive director of the EMA.

History of the agreement

November 2017 marked the beginning of the mutual recognition agreement between the two authorities, which has seen EU member states assessed to determine whether their GMP inspections matched FDA standards.

Since this time, countries have been continually added in batches, before the last country to be added, Slovakia, was also inducted into the arrangement.

The process has been in development since 1998, when the EU and the US signed a mutual recognition agreement that included a ‘pharmaceutical annex’, allowing for limited reliance on each other’s GMP inspections.

In addition to this mutual recognition agreement, the EU has also fostered a closer relationship with the Japanese regulatory authority, as the global regulatory network moves towards greater collaboration.