European Social Insurance Platform (ESIP)
Maison Européenne de la Protection Sociale
rue d’Arlon 50
1000 Brussels
T central: +32 (0)2 282 0560
T direct: +32 (0)2 282 0562
Fax: +32 (0)2 282 0598
E-mail: christine.dawson@esip.eu
Web: www.esip.eu
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.