Mutual Recognition promises new framework for pharmaceutical inspections for United States and European Union

Mutual Recognition promises new framework for pharmaceutical inspections for United States and European Union

Mutual Recognition promises new framework for pharmaceutical inspections for United States and European Union

 

On 2nd of March 2017 United States and European Union accomplished exchange of letters to amend the Pharmaceutical Annex to the 1998 U.S.-EU Mutual Recognition Agreement. According to this agreement USA and EU will use each other’s GMP inspections of pharmaceutical manufacturing facilities.

The amended agreements will ‎represent the culmination of nearly three years of U.S. Food and Drug Administration and EU cooperation as part of the Mutual Reliance Initiative. It will allow USFDA and EU to access database of each other. Having this agreement firms from Europe and USA will not be able to duplicate inspection of drugs, reduction of inspection cost and will also enable regulators to devote more resources to other parts of world.

Dara Corrigan, FDA’s associate, Global regulatory policy said that “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”

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.

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 promotes and protects public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

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