U.S. and Europe Reach Mutual Recognition of Inspection Milestone

Jul 22, 2019 | EMA Approval, European Medicines Agency, FDA, Mutual Recognition

inspections for human medicines

The European Union and the United States have fully implemented the Mutual Recognition Agreement, or MRA, for inspections of manufacturing of (bio) pharmaceutical sites for certain human medicines in respective territories. Apparently, the deal was inked after the U.S. FDA recognized Slovakia as a partner in the agreement.

Under the MRA, EU and American regulators can now rely on each other’s inspections for human medicines in their own territories and, consequently, reduce or even completely avoid duplicate work. The MRA will free up resources so inspection teams from the EU and the U.S. can inspect facilities in other countries, considering the growth in places such as India or China, this becomes increasingly important. The recent news was reported in OncoZine. Follow the link below to learn more.


Pin It on Pinterest