CRED 8 Presentations

01/07/2024

• Module 1 will be different • The remaining modules could (in theory) be identical for multiple regions • Some notable exceptions, e.g. Module 3.2.R • However… • Different regions have different expectations for some sections of the eCTD • Guidance and interpretation may affect content for each region • But…a global dossier is possible • Critical to understand your global filing strategy, and where the EU fits eCTD…Identical for all Regions?

The Organisation for Professionals in Regulatory Affairs

41

Eligibility

18-7 months before MAA submission

• Submit an eligibility request using a specific form with accompanying justification • Deadlines published on the EMA website • Article 3 of Regulation (EC) No 726/2004 defines the scope and eligibility: • “Mandatory Scope” [Article 3(1)] e.g. Medicinal products developed through biotechnological processes (including biosimilars), Advanced therapy medicinal products*, New active substance, Orphan medicines, Certain therapeutic areas with high unmet need. • “Optional scope” [Article 3(2)(a) and (b)] e.g. New active substance, Medicinal product that constitutes a significant therapeutic, scientific or technical innovation, or that the granting of authorisation is in the interest of patients at Union level • “Others” e.g. Generic/Hybrid, Duplicate MAAs, New paediatric indications, Known substance in new combinations etc

See “Pre-authorisation guidance - section 2: Steps prior to submitting the application” and “Obtaining an EU Marketing Authorisation, Step-By-Step”

The Organisation for Professionals in Regulatory Affairs

Abbreviations: MAA – marketing authorisation application

42