Report on the Pilot EMA-FDA GCP Initiative, September 2009 – March 2011

Two pilot programmes of collaboration on inspections between the European Medicines Agency (EMA) and its international partners in the United States and Australia have concluded successfully, according to two reports published on 2 August 2011.

The report on the joint good clinical practice (GCP) inspection pilot programme details the success of information-sharing and collaboration on inspections relating to clinical trials between EMA and the United States Food and Drugs Administration (FDA). (Please click on Source Url)

The report on the joint active pharmaceutical ingredients (API) inspections pilot programme details the success of information-sharing and collaboration on API inspections among the participating authorities (EMA, France, Germany, Ireland, Italy, United Kingdom, EDQM, FDA and Australia’s Therapeutic Goods Administration (TGA)). (Please click on Related Url)

The two programmes focus on increasing international regulatory collaboration among the regulatory agencies so that drug quality and safety can be enhanced globally.

EMA: Press Release: EMA/612563/2011 (2.8.11) http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2011/07/news_detail_001302.jsp&murl=menus/news_and_events/news_and_events.jsp&mid=WC0b01ac058004d5c1

EMA et. al.: Final report on the International API inspection Pilot Programme http://www.ema.europa.eu/docs/en_GB/document_library/Report/2011/07/WC500108655.pdf

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