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Post-Authorization Efficacy Studies

A Post-Authorization Efficacy Study (PAES) is a study conducted within the authorized therapeutic indication to complement available efficacy data. These studies take into consideration well-reasoned scientific uncertainties on the evidence of benefits that could not be resolved prior to authorization or where identified after authorization. PAES could also include additional secondary objectives. Safety data are always important in these studies.

PAES may be imposed by authorities at the time or after granting the marketing authorization. They can be interventional or observational. A scientific guidance on PAES in EU is expected in 2016.

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