Spring Intro 2023

16/02/2023

Post-Authorisation Safety Study (PASS)

What is a PASS? ● Study conducted after authorisation to obtain further information on safety OR to measure effectiveness of risk-management measures. ● PASS can be imposed (PRAC) or voluntarily proposed (MAH) ● Outlined in the RMP How are the protocol/results assessed? ● Protocol & final study report assessed by PRAC

RMP Cat. Type

Status

1 2 3 4

Imposed PASS

Mandatory & subject to penalties

Specific Obligation

Required

Legally enforceable Non imposed PASS

Stated

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Post-Authorisation Efficacy Study (PAES)

• What are PAES? – Efficacy study requested by a Competent Authority, results potential to impact the B/R of product or PI – Complements available efficacy data – Requested at time of granting initial MA or post-approval – Applies to a standard / conditional MA, MA granted in exceptional circumstances, to an advanced therapy, paediatric use, referral • How are the protocol/results assessed? – Protocol & final study report assessed by CHMP/RMS/NCA – Interim reports can also be requested/submitted for assessment • How do I know if a product is subject to PAES? – Details outlined in Annex IIB and RMP part IV ‘Plans for post-authorisation efficacy studies’

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