Press Release: European Medicines Agency and FDA announce launch of generic medicines application inspections initiative

The European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA), on 18 December 2013, announced the launch of a joint initiative to share information on inspections of bioequivalence studies submitted to the EMA, the FDA and/or to the regulatory authorities in some EU Member States in support of marketing-authorisation applications for generic medicines. The joint initiative also introduces a mechanism to conduct joint inspections of facilities where these bioequivalence studies are conducted.

The EU Member States initially involved in this initiative are France, Germany, Italy, the Netherlands and the United Kingdom. Additional Member States are expected to join the initiative in the future.

EMA: Press Release: EMA/797904/2013 (18.12.13): European Medicines Agency and FDA announce launch of generic medicines application inspections initiative http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2013/12/WC500158545.pdf

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