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US and EU: the US FDA and EMA will share work in relation to GMP inspections

16/12/2011

A press release issued on 9th December 2011 confirms that the FDA and EMA are launching an initiative to share work on inspections of manufacturing sites in each other's territories.  This 'co-operation' will start in January 2012 and will apply to inspections of manufacturing sites (human and veterinary) in the EEA or USA.

 

It makes sense that these two agencies should work together.  There is far too much duplication of effort.  This effort will be better used elsewhere.

 

For detailed information on the Press Release, please click here.

 

Author: Greer Deal, Director of Global Regulatory Services