GMP topical

28.06.2019

EU/US MRA: Germany finally recognised as 27th EU Member State

On 26 June 2019, the US FDA granted Germany the ability to carry out GMP inspections at a level equivalent to that of the USA. With this, the MRA between the US and the EU has almost reached its goal: By 15 July 2019, the recognition of all 28 EU Member States should be completed.

Slovakia is still awaited to round off the list of EU states on whose inspection results the FDA will rely in future. On 27 June, the EMA published a revised version of the Question and Answer Paper on the key issues of the MRA.

Further information on the MRA itself can be found here.

Source:

EC Public Health: Newsroom

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