European Medicines Agency and United States Food and Drug Administration to share manufacturing site inspections

Author (Corporate)
Series Title
Series Details 9.12.11
Publication Date 09/12/2011
Content Type

The European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) are launching an initiative to share work on inspections of manufacturing sites in each other's territories. The initiative, starting in January 2012, will enable the two authorities to rely on each other's inspection outcomes rather than carrying out separate inspections in duplicate.

Source Link Link to Main Source http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2011/12/news_detail_001399.jsp&mid=WC0b01ac058004d5c1
Related Links
EMA/FDA: Enhancing GMP inspection cooperation between the EMA and FDA: Moving from confidence-building to reliance upon http://www.ema.europa.eu/docs/en_GB/document_library/Other/2011/12/WC500118766.pdf

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