Operations and Regulatory Consulting, Quality, Compliance, GMP, Regulatory

EU & US MRA Fully Operational – What You Need to Know!

July 25, 2019 ||
Background In 1998, the EU and the US signed a broad Mutual Recognition Agreement (MRA), which included a Pharmaceutical Annex providing for anticipated and limited reliance on each other’s Good Manufacturing Practice (GMP) inspections. However, this Agreement was never fully implemented.