Module 6

04 October 2024

Accelerated assessment for PRIME products

Highlights of the 5-year PRIME report : 2016-2021

• Increased chance of granting and keeping an Accelerated Assessment for PRIME products

• Significant reduction in average evaluation time , especially for SME products

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An Agency perspective: the success and failure of a medicinal product in the EU

Classified as public by the European Medicines Agency

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Presubmission interaction with EMA

EMA “Core Team” : Product Lead (PL) , Quality and Regulatory Product Team members Additional offices (as relevant): Orphan Medicines, SME, Paediatric Medicines, Labeling, Scientific Advice, Manufacturing and Qualify Compliance, Clinical and Non- clinical Compliance, Procedure Office, Specialised Scientific Disciplines (e.g Non-Clinical, Biostatistics, Clinical Pharmacology)

Who interacts

Day 180

Day 120

- Product-Specific legal, regulatory and scientific issues for validation and assessment purpose This is not a preassessment of the applicant submission!

Scope

- MAA presubmission interaction form available on website - Key Annexes: Briefing Document, Draft TOC, Draft eAF and PI - Centralised through EMA Service Desk

Request

- In writing and follow up TC as needed e.g complex issues identified - Joint EMA/Rapporteurs TC possible - Using directly the applicant completed form (dedicated sections for the EMA responses

Review /outcome

Examples of feedback: Appropriate legal basis, Justification needed (missing data, SA non- compliance), ‘Premature’ dossier and CHMP clock stop rules, Additional regulatory and scientific guidance, comments on eAF, PI, TOC, applicants claim (AA, similarity, NAS, CMA, eMA)

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An Agency perspective: the success and failure of a medicinal product in the EU

Classified as public by the European Medicines Agency

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