Background

The U.S. and the European Union have amended the pharmaceutical annex to their 1998 mutual recognition agreement to allow authorities to rely on information from inspections of human drug manufacturing facilities conducted within each other’s borders. A press release from the Food and Drug Administration states that ultimately this will enable the two sides to avoid the duplication of drug inspections, lower inspection costs, and enable regulators to devote more resources to other parts of the world that produce medicines and active pharmaceutical ingredients for the U.S. and EU markets where there may be greater risk. An EU press release states that many provisions of this agreement have already entered into force and others will take effect Nov. 1.

The FDA Safety and Innovation Act enacted in 2012 gave the FDA authority to enter into agreements to recognize drug inspections conducted by foreign regulatory authorities if the FDA determines that those authorities are capable of conducting inspections that meet U.S. requirements. The EU already has MRAs on good manufacturing practice inspections with several countries, including Australia, New Zealand, Canada, Japan, and Switzerland.

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