EFFECTIVE this month, the European Union and the United States of America have agreed to place into operation more aspects of their mutual recognition agreement which allows for acknowledgement of each other's GMP inspection outcomes and hence for better use of inspection expertise and resources.
This is the first time the FDA has agreed to recognise another countries procedures and addresses the fact that for around 85% of medicines sold in the EU, at least one manufacturing step takes place outside the Union, the European Medicines Agency said.
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