> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Mutual Reliance Initiative Expands Drug Inspections
- URL: https://www.fdaweb.com/mutual-reliance-initiative-expands-drug-inspections/
- Published: 2016-12-07T12:00:00.000Z
- Updated: 2026-09-14T21:53:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137508

FDA associate commissioner for global regulatory policy **Dana Corrigan** says a Mutual Reliance Initiative (MRI) with the European Union (EU) allows FDA and EU inspectors to work together, relying on each other’s inspections, avoiding duplication, and conducting more inspections. Writing in an *FDA Voice* blog [post](http://blogs.fda.gov/fdavoice/index.php/2016/12/the-mutual-reliance-initiative-a-new-path-for-pharmaceutical-inspections-in-europe-and-beyond/?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery), Corrigan says the MRI was launched 5/2014.

As part of the implementation, she writes, the two regulatory bodies assembled dedicated teams to assess the risks and benefits of entering into a mutual recognition agreement. As part of the process, FDA has been invited to observe 13 joint audits in which two EU nations audit the regulatory authority of a third member country.

“This unprecedented access allows FDA observers to gather firsthand knowledge of the laws that govern EU GMP drug inspections and how inspectorates (regulatory authorities) manage the drug inventory within their respective borders,” Corrigan says. “Also, interacting with auditors across the EU provides a unique opportunity to understand the regulatory framework in the EU.”

The post notes that the UK’s coming departure from the EU has had no impact on FDA relationships. It is anticipated that once the “Brexit” is completed, FDA and the UK will examine existing commitments and, if necessary, renegotiate any agreements, it says.

Corrigan says FDA hopes to sign an agreement with the EU soon and is working to complete assessments of the capability of the drug manufacturing inspectorates of two to four countries in the EU. “These first steps with the EU will lead toward our goal of an expanded inspectorate, containing investigators and inspectors from FDA and from across the EU,” she concludes. “These collaborations will enhance our ability to evaluate risk, produce better data, and minimize public health risk globally.”