US and EU Reach Agreement on Pharmaceutical Inspections

On March 2, 2017 the US FDA and the European Medicines Agency announced that the Agencies had completed an exchange of letters amending the 1998 US-EU Mutual Recognition Agreement.  

The exchange of letters is the culmination of nearly three years of work between the two Agencies that began in May 2014 with the initiation of the Mutual Reliance Initiative (MRI).  This amended agreement allow drug inspectors from the FDA to recognize and utilize current Good Manufacturing Practice (cGMP) drug inspections conducted by the EU drug inspectors and vice versa.   Considering that approximately 40% of the US FDA’s drug inspections over the past 5 years were conducted in the EU, this amended agreement should result in a significant reduction in foreign inspection costs for the FDA. 

In addition, this agreement should significantly decrease the number of redundant inspections and free up resources for both Agencies to address issues in other regions that may pose a higher level of risk.   From a manufacturers perspective, this amended agreement should decrease the regulatory burden caused by the repetitive cGMP inspections.

To see the official announcements follow the links below:

US Announcement

EU Announcement

To learn more about the EU-US Mutual Reliance Initiative follow the links below:

The Mutual Reliance Initiative: A New Path for Pharmaceutical Inspections in Europe and Beyond

EU – US Mutual Reliance Initiative