News about GMP/cGMP

03.03.2017

US and EU: Final Mutual Recognition Agreement for GMP Inspections

Following a three-year-process, the United States (represented by the US FDA) and the European Union (represented by the European Commission) have now finally announced their agreement to mutually recognise each other's GMP inspections of pharmaceutical facilities.

 

A press release of the US FDA states that “this will now allow the FDA and European drug inspectors to rely upon information from drug inspections conducted within each other’s borders. Ultimately, this will enable both sides 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 Agreement marks an important step and was originally part of the Transatlantic Trade an Investment Partnership TTIP under President Obama (as already reported).  The process started in May 2014. Since then, the FDA has been invited to observe the EU’S Joint Audit Program, in which two EU nations audit the inspectorate – the regulatory authority – of another EU country.

Currently, EU has such mutual recognition GMP agreements in place with Switzerland, Australia, New Zealand, Japan, Canada (with some limitations) and Israel (with some exclusions).

The mutual Recognition Agreement between the US and the EU now enters into force following the signature by both parties, while the recognition of inspections can apply as early as November of this year.


Source:

EU: Trade

FDA: Press Announcement

Sectoral Annex on GMP of the Mutual Recognition Agreement

 



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