Mutual reliance between the United States Food and Drug Administration and the European Union on good-manufacturing-practice inspections

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TitleMutual reliance between the United States Food and Drug Administration and the European Union on good-manufacturing-practice inspections
Date14/11/2014 - 17/11/2014
LocationEuropean Medicines Agency, London, UK
SummaryOn 14 and 17 November 2014, representatives of the United States Food and Drug Administration (FDA) are meeting with a cross-agency team from the European Medicines Agency (EMA), the European Commission and good-manufacturing-practice (GMP) experts from European Union (EU) Member States in order to make progress on mutual reliance between the FDA and EU on GMP inspections. Initiatives have been ongoing in this field for several years but there is now renewed momentum on this issue. Representatives of both teams have met several times in recent months, answered questions and exchanged information. This meeting is the first face-to-face meeting of both complete teams specifically organised on this topic. It is intended to clarify and align aspirations and goals, detailed scope and timelines as well as to continue the exchange of information, clarification and discussion on respective systems for supervision of manufacturers.

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