Clinical Trial Annual Reports

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Chapter: Pharmacovigilance: Periodic Safety Update Reports

Clinical trial annual reports are a requirement of the 2001 European Union Clinical Trials Directive which came into effect on 1 May 2004.


CLINICAL TRIAL ANNUAL REPORTS

Clinical trial annual reports are a requirement of the 2001 European Union Clinical Trials Directive which came into effect on 1 May 2004. The manufacturer or sponsor is required to report both to the competent authority and to the ethics committee in each member state, as set out in a detailed guidance published by the European Commission (EC, 2004b). This guid-ance applies to all clinical trials on medicinal prod-ucts for human use conducted within the European Community. Importantly, it applies to all investiga-tional medicinal products for human use, regardless of their marketing authorisation status in any member state or whether they are used under the conditions of marketing authorisation. It provides detailed guid-ance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials. Although it does not cover spontaneous post-marketing ADRs, the introduction of this European directive, along with the proposed regulations in the US regarding safety reporting for human drugs and biological products (FDA, 2003), is indicative of a global trend towards more rigorous regulation of prod-uct safety which will inevitably have implications for PSURs and the resources that companies devote to producing them.

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