News about GMP/cGMP
On 14 September 2018 the FDA has confirmed the capability, capacity and procedures in place of Portugal to carry out GMP inspections at a level equivalent to the US. There are now a total of 15 European Member States whose inspection results the FDA relies 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 to the listing of Portugal, EMA revised the 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. Furthermore, it clarifies questions regarding combination products or import re-testing.
More detailed information on the MRA can be found here.
EMA: News and Events