EU-US mutual recognition extends with Portugal added to roster

24-Sep-2018 - Last updated on 24-Sep-2018 at 10:50 GMT

(Image: Getty/Evgeny Gromov)

With the US recognising Portugal’s ability to carry out GMP inspections, 15 countries are now part of the mutual recognition agreement between the EU and the US.

In waves, the US Food and Drug Administration (FDA) has been revealing the European Union (EU) countries that meet its good manufacturing practice (GMP) inspections standards.

The mutual recognition agreement discussions between the US and EU had steadily moved closer to reaching a deal, with a series of smaller understandings, before the official announcement on November 1, 2017, that the two countries would officially begin the process.

The mutual recognition arrangement sees the workload of both agencies reduced, as the review of facilities then do not need to be replicated once any member of the agreement has carried out GMP inspections.

The process began with eight EU countries but has slowly increased in number and, with the addition of Portugal, now includes 15 countries that the FDA recognises as having the same standards as those held during its own inspections.

The planned timeline of the understanding sees a deadline of July 15, 2019, for all EU countries to be inducted into the mutual recognition agreement.

In a statement, the EMA explained, “The agreement is underpinned by robust evidence on both sides of the Atlantic that the EU and the US have comparable regulatory and procedural frameworks for inspections of manufacturers of human medicines.”

Beyond the EU-US agreement, there is also a move by the EU towards closer ties to Japan’s Pharmaceuticals and Medical Devices Agency. In the most recent development of this relation, in July of this year, the EU and Japan agreed to extend mutual recognition to biologics and active pharmaceutical ingredients.