GMP topical

15.02.2019

EU/US MRA on Inspections: Poland and Slovenia accepted

On 7 February 2019, the FDA has confirmed the capability, capacity and procedures in place of Poland and Slovenia to carry out GMP inspections at a level equivalent to the US. This concludes the FDA's assessment of a total of 22 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. As Germany is still not officially recognised, the US FDA will continue to carry out its inspections there.

In addition to the listing of Poland and Slovenia, 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: Press Release

EMA: Q&A

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