If you have an ACS member number, please enter it here so we can link this account to your membership. (optional)

ACS values your privacy. By submitting your information, you are gaining access to C&EN and subscribing to our weekly newsletter. We use the information you provide to make your reading experience better, and we will never sell your data to third party members.



U.S. and EU to share pharma inspection reports

by Britt E. Erickson
March 13, 2017 | A version of this story appeared in Volume 95, Issue 11

Credit: Shutterstock
Photos shows pharmaceutical production line with a series of oblong tablets.
Credit: Shutterstock

U.S. and European Union regulators have agreed to recognize each other’s inspection reports of pharmaceutical manufacturing facilities. The decision is expected to help FDA and EU drug inspectors avoid duplicating inspections. It’s also expected to lower inspection costs and help regulators focus resources in parts of the world where the risk of unsafe drugs is the greatest. The agreement comes after nearly three years of collaboration between FDA and EU inspectors to assess the risks and benefits of relying on foreign inspections of drug manufacturing facilities. Congress gave FDA the authority to use foreign drug inspection reports in 2012 with the passage of the FDA Safety & Innovation Act. The law allows FDA to recognize foreign inspections as long as those inspections meet U.S. requirements. “The Mutual Recognition Agreement is an important step in working collaboratively and strategically with key partners to help ensure that American patients have access to safe, effective, and high-quality drugs,” says Dara Corrigan, FDA’s associate commissioner for global regulatory policy.


This article has been sent to the following recipient:

Chemistry matters. Join us to get the news you need.