Press Release: European Medicines Agency and US Food and Drug Administration announce pilot program for parallel assessment of Quality by Design applications

Author (Corporate)
Series Title
Series Details EMA/197051/2011 (16.3.11)
Publication Date 16/03/2011
Content Type

The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), on 16 March 2011, launched a three-year pilot program that will allow parallel evaluation of relevant quality data components, known as Quality by Design (QbD), of selected applications that are submitted to both agencies at the same time. The pilot start on 1 April 2011.

Source Link Link to Main Source http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2011/03/news_detail_001222.jsp&murl=menus/news_and_events/news_and_events.jsp&mid=WC0b01ac058004d5c1
Related Links
EMA: Press Release: EMA/197051/2011 (16.3.11) http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2011/03/news_detail_001222.jsp&murl=menus/news_and_events/news_and_events.jsp&mid=WC0b01ac058004d5c1

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