EMA and FDA launch joint generics inspections

Home/Policies & Legislation | Posted 17/01/2014 post-comment0 Post your comment

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) will work together to ensure the safety of generic medicines. It is hoped that streamlining the inspection process for generic drug applications will help consumers gain access to safe and effective generics.

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The agencies announced on 18 December 2013 the launch of a joint initiative to share information on inspections of bioequivalence studies submitted in support of generics approvals. The collaboration provides a mechanism to conduct joint facility inspections for generics applications submitted to both agencies.

Taking part in this initiative are EMA and the EU Member States France, Germany, Italy, The Netherlands and United Kingdom. This initiative will be implemented using confidentiality agreements established between the European Commission, EMA, interested EU Member States and FDA.

Key objectives of the initiative are to streamline information sharing on inspections of bioequivalence studies conducted and planned for generics applications, with inspectional information being shared for clinical and/or analytical facilities; to share information about negative inspection outcomes that reveal system problems at a facility; to conduct joint inspections at facilities all over the world; and to provide training opportunities to improve bioequivalence inspections.

This agreement includes an 18-month pilot phase and follows the successful collaboration carried out between EMA and FDA focussed on good clinical practice (GCP). The agencies also launched a three-year pilot programme in April 2011 allowing parallel evaluation of quality elements, known as Quality by Design (QbD), of selected applications that are submitted to both agencies at the same time [1].


1.  GaBI Online - Generics and Biosimilars Initiative. Pilot programmes between EMA, FDA and TGA a success [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jan 17]. Available from: www.gabionline.net/Generics/General/Pilot-programmes-between-EMA-FDA-and-TGA-a-success

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Source: EMA, FDA

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