European Commission

ESIPEuropean Social Insurance Platform  (ESIP)

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E-mail:  christine.dawson@esip.eu

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Press release

The United States and the EU have agreed to amend the Pharmaceutical
Annex to the 1998 US-EU Mutual Recognition Agreement (MRA), allowing the
US and the EU to utilize each other’s good manufacturing practice (GMP)
inspections of pharmaceutical manufacturing facilities.

The MRA is a legally binding treaty between the US and the EU to be able
to exchange GMP Certificates based on equivalent GMP Compliance
Program.

This agreement is a result of three years of negotiations and
cooperation between the USFDA and the EU, as a part of the Mutual
Reliance Initiative (MRI). The agreement will now allow drug inspectors
to have access to information on inspections conducted within their
respective jurisdictions. The agreement is a step forward to avoid
duplication of drug inspections and will contribute to decreased
inspection costs.