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News about GMP/cGMP

2018-06-08

EU/US: MRA on Inspections – Lithuania and Ireland Added and Q&A Published

The US Food and Drug Administration (FDA) confirmed the capability of Lithuania and Ireland to carry out GMP inspections at a level equivalent to the US.

 

There are now a total of 14 Member States whose inspection results the FDA can rely on to replace their own inspections.

According to the EMA the plans for the agreement to come into operation in all EU Member States by 15 July 2019 are well on track. As Germany is still not officially recognised, the US FDA will continue to carry out its inspections there.

In addition, on 1 June 2018 EMA published a Q&A on the MRA. It informs inter alia about what products are included in the scope of the MRA as well as what products are excluded. It also deals with combination products and import testing.

Source:

EMA: What's new

Q&A on the impact of MRA between the EU and the US

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