CRED 8 Presentations

01/07/2024

Accelerated assessment eligibility request* At least 2-3 months before Submission • Must contain justification that medicinal product is of major public health interest , particularly from the point of view of therapeutic innovation • Recommended to submit after discussing proposal with EMA/Rapporteurs during pre submission meetings (including how Company will manage timelines) • PRIME scheme products should make use of PRIME meetings to also discuss • Submit through the EMA service desk including: • Pre-submission request form, Justifications for request and Information for early identification of pre-authorisation inspections • If request is accepted the timetables/deadlines for accelerated assessment apply • You and your company must commit to the timelines; the Rapporteurs and EMA will make the same commitment

* Optional step only for medicinal products that may be eligible

Accelerated assessment is 150 days as opposed to 210 standard review

The Organisation for Professionals in Regulatory Affairs

47

Other Requirements: PIP Compliance

At least 3 months before Submission

• Partial compliance check: For PIPs with deferred completion, binding elements/measures that have a due date in advance of MAA submission date checked. • Full compliance check: No measures deferred, must be completed in advance of MAA. • Discuss PIP compliance at EMA pre-submission meeting. • Compliance check assessed by the Paediatrics Committee (PDCO) per published timetables • 60 days review for PDCO to assess. • PIP Compliance statement should be included in Module 1.10 of MAA. • Negative compliance will prevent whole MAA being validated!!!

Abbreviations: PIP = MAA = marketing authorisation application, PIP = Paediatric Investigation Plan

The Organisation for Professionals in Regulatory Affairs

48