CRED 8 Presentations

01/07/2024

Types of Application

• Biosimilars and generics/hybrids: •

Mandatory scope of application (Reference product/comparator is a centrally approved MA) • Optional scope (reference / comparator product has national/MRP/DCP) • Advanced therapy Medicinal Products (ATMPs): • Complex therapies; seek a classification in advance of applying for MAA • Different Regulatory Framework and EMA Pre-submission Q&As: • Generics/hybrids/biosimilars/ATMPs have different legal basis and are regulated by additional sets of regulations and guidance's e.g. ATMP Regulation 1397/2007 • Different dossier requirements e.g. biosimilars: dossier based on totality of comparability exercise data e.g. step-wise approach for biosimilars to show no clinically meaningful differences (CMC heavy, less clinical data)

The Organisation for Professionals in Regulatory Affairs

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Recap

Content and Preparation of eCTD

Reference: EudraLex Volume 2:https://ec.europa.eu/health/documents/eudralex/vol-2_en

The Organisation for Professionals in Regulatory Affairs

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