News about GMP/cGMP

14.06.2019

EU/US MRA on inspections: Luxembourg and the Netherlands accepted

On 10 June 2019, the FDA has confirmed the capability, capacity and procedures in place of Luxembourg and the Netherlands to carry out GMP inspections at a level equivalent to the US. This concludes the FDA's assessment of a total of 26 EU member states, whose inspection results will be trusted in the future. This process is to be completed for all EU states by 15 July 2019.

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. Germany and Slovakia are still not officially recognised. The US FDA will continue to carry out its inspections there.

Along with the listing of Luxembourg and the Netherlands, the EMA has revised the Q&A on the MRA. It informs inter alia about which products are included or not in the scope of the MRA. Furthermore, it clarifies questions regarding combination products or the necessity of import re-testing. By the way: this control must still be carried out until all European member states have been approved by the FDA.

More detailed information on the MRA can be found here.


Source:

EMA: News and Events



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