The US FDA now grants all 28 EU member states the ability to conduct GMP inspections at a level equivalent to that of the US. The authorities responsible in the USA and the EU no longer have to carry out their own inspections of manufacturing sites, but can rely on reliable inspection results from the other side. Thereby the deadline of 15 July 2019 has been met.
What are the benefits?
This is the result of five years of collaboration between teams from the European Commission, EU national authorities, the European Medicines Agency (EMA) and the US FDA. Work will continue to achieve application of the MRAs to veterinary medicines, human vaccines and plasma-derived medicines.
In order to achieve the goal of mutual recognition, the EMA has published a revised version of the Question and Answer Paper on the key issues of the MRA.
EC: Press release
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