EU: Draft Scientific Guidance on Post-Authorisation Efficacy Studies

This guidance is intended to provide scientific guidance for marketing-authorisation holders and national competent authorities on post-authorisation efficacy studies with regard to methodological considerations and the potential role of particular study designs. This guidance does not include procedural aspects, which are dealt with in the human post-marketing authorisation regulatory and procedural guidance.
Go to: EMA Draft Scientific Guidance on Post-Authorisation Efficacy Studies (06-Nov-2015)

• Email address for submissions: paesconsultation@ema.europa.eu
• Comments should be submitted using this template: http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2009/10/WC500004016.doc

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