Module 6

02/10/2024

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Lifecyle: Post Authorisation Efficacy Studies (PAES) What is it? How is it imposed?

• A PAES is an efficacy study requested by a Competent Authority, results have potential to impact to the benefit/risk of the product profile and modified or new data is updated in the product information.

• The new PAES data could complement existing available efficacy data

• Requested at time of granting initial MA or post-approval commitment or a specific obligations as part of the conditional approval of the MA. The study outline is detailed in the product Information’s Annex - IIB and RMP part IV ‘Plans for post -authorisation efficacy studies’ • The PAES can apply to a standard / conditional MA, MA granted in exceptional circumstances, to an advanced therapy, paediatric use, referral

• The protocol and the final study results/report are assessed by CHMP / RMS/ NCA

• Interim reports can also be requested/submitted for assessment

The Organisation for Professionals in Regulatory Affairs

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