US-EMA mutual recognition has two months to go and four countries left

By Ben Hargreaves contact

- Last updated on GMT

(Image: Getty/Klenger)
(Image: Getty/Klenger)

Related tags: Ema, Bulgaria, Cyprus, Food and drug administration, Mutual recognition

The EMA adds Bulgaria and Cyprus to the US-EU mutual recognition pact, leaving four countries to be added ahead of July 15.

The European Medicines Agency (EMA) announced that Bulgaria and Cyprus had been confirmed as capable of carrying out good manufacturing practice (GMP) inspections to the level required by the US Food and Drug Administration (FDA).

With the two countries joining the agreement, there are only four European Union (EU) countries left to be added to complete the mutual recognition of GMP inspections between the EU and the US.

Germany, Luxembourg, the Netherlands, and Slovakia are still to be confirmed as meeting requirements, ahead of a deadline of July 15 of this year.

The EMA noted that actions to have the agreement operational across all EU member states are ‘progressing.’

The EU recognised the ability of the US FDA to carry out GMP inspections to the required level in November 1, 2017.

Since this time, there have been regular updates from the EMA, as further member states are confirmed to the agreement​.

The aim of the agreement is to avoid the duplication of work and to share the resource burden that comes with carrying out inspections across the globe.

The EU has agreed similar arrangements with other countries, including extending its agreement with Japan last year​.

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