Post-Authorisation Efficacy Study (PAES)

EU: EMA Scientific Guidance on Post-Authorisation Efficacy Studies – Post authorisation efficacy studies (PAES) of medicinal products are studies subsequently conducted within the authorised therapeutic indication to address well-reasoned scientific uncertainties identified by EU regulators on aspects of the evidence of benefits that should be, or can only be, addressed post-authorisation.  A PAES may, therefore, be needed at the time of the initial MA or the extension of an existing MA where there is a well-reasoned scientific uncertainty on an aspect of the established therapeutic efficacy and the resolution of this uncertainty is important for further understanding this aspect of benefit-risk. The uncertainty should also be such that it may be addressed post-authorisation by a study that can be designed and conducted to give interpretable results with the potential to impact on the MA status or product labelling (as per Section 1 of the EMA Scientific Guidance on Post-Authorisation Efficacy Studies – Oct 2016)

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