New Tool: ProSource
Checkout our packaging and processing solutions finder, ProSource.

FDA Announces New Framework for Pharmaceutical Inspections

New agreement means U.S. and E.U. regulators will be able to utilize each other’s good manufacturing practice inspections of pharmaceutical manufacturing facilities.

The U.S. and the European Union (E.U.) completed an exchange of letters to amend the Pharmaceutical Annex to the 1998 U.S.-EU Mutual Recognition Agreement. Under this agreement, U.S. and E.U. regulators will be able to utilize each other’s good manufacturing practice inspections of pharmaceutical manufacturing facilities.
The U.S. and the European Union (E.U.) completed an exchange of letters to amend the Pharmaceutical Annex to the 1998 U.S.-EU Mutual Recognition Agreement. Under this agreement, U.S. and E.U. regulators will be able to utilize each other’s good manufacturing practice inspections of pharmaceutical manufacturing facilities.

The U.S. and the European Union (E.U.) completed an exchange of letters to amend the Pharmaceutical Annex to the 1998 U.S.-E.U. Mutual Recognition Agreement. Under this agreement, U.S. and E.U. regulators will be able to utilize each other’s good manufacturing practice inspections of pharmaceutical manufacturing facilities.

The amended agreement ‎represents the culmination of nearly three years of U.S. Food and Drug Administration and E.U. cooperation as part of the Mutual Reliance Initiative and will allow the FDA and E.U. drug inspectors to rely upon information from drug inspections conducted within each other’s borders. Ultimately, this will enable the FDA and EU to avoid the duplication of drug inspections, lower inspection costs and enable regulators to devote more resources to other parts of the world where there may be greater risk.

“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.

In 2012, Congress passed the Food and Drug Administration Safety and Innovation Act, which gave the FDA authority to enter into agreements to recognize drug inspections conducted by foreign regulatory authorities if the FDA determined those authorities are capable of conducting inspections that met U.S. requirements.

Since May 2014, the FDA and the EU have been collaborating to evaluate the way they each inspect drug manufacturers and assessing the risk and benefits of mutual recognition of drug inspections. The FDA was invited to observe the EU’s Joint Audit Programme, in which two E.U. nations audit the inspectorate—the regulatory authority—of another E.U. country. The FDA first observed the audit of Sweden’s inspectorate by auditors from the United Kingdom and Norway. Since then, the FDA has observed 13 additional audits of drug inspectorates across the EU with more audit observations planned through 2017.

How to Honor a Leader
Induction into the Packaging & Processing Hall of Fame is the highest honor in our industry. Submit your leader to be considered for the Class of 2024 now through June 10th. New members will be inducted at PACK EXPO International in Chicago.
Read More
How to Honor a Leader
Test Your Supply Chain Smarts
Take Healthcare Packaging's supply chain quiz to prove your knowledge!
Read More
Test Your Supply Chain Smarts