News about GMP/cGMP

03.05.2019

EU/US MRA on Inspections: Bulgaria and Cyprus accepted

On 29 April 2019, the FDA has confirmed the capability, capacity and procedures in place of Bulgaria and Cyprus to carry out GMP inspections at a level equivalent to the US. This concludes the FDA's assessment of a total of 24 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, Luxembourg, the Netherlands and Slovakia are still not officially recognised. The US FDA will continue to carry out its inspections there.

In addition to the listing of Bulgaria and Cyprus, 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.


Quelle:

EMA: News



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