CRED ERP 25

01/07/2025

Learning Outcomes: Recap

• To gain a good understanding of EU regional requirements for the regulatory dossier • To be aware of some key considerations when preparing eCTD module 1 components for the EMA (for an EU centralised) and Reference Member State (for MRP/DCP)

• Electronic dossier format (eCTD) • Labelling and leaflets including readability testing • Translations • Pharmacovigilance Site Master File and Risk Management Plan • Environmental Risk Assessment • Orphan Drugs • Paediatric Investigational Plan • Manufacturing aspects – site inspections, QC testing and QP release

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References/sources

• Notice to Applicants: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol 2/b/update_200805/ctd_05-2008_en.pdf

• Pre authorisation guidance on EMA website: https://www.ema.europa.eu/en/human-regulatory/marketing authorisation/pre-authorisation-guidance) • Harmonised Technical Guidance for eCTD Submissions in the EU: http://esubmission.ema.europa.eu/tiges/docs/eCTD%20Guidance%20v5.0_adopted%20version.pdf

• EU Module 1 eCTD Specification: http://esubmission.ema.europa.eu/eumodule1/EU%20M1%20eCTD%20Spec%20v3.0.4.pdf • Validation issues frequently seen with initial MAAs: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2017/12/WC500239942.pdf

• Dossier administration validation check list: https://www.ema.europa.eu/en/human-regulatory/marketing authorisation/marketing-authorisation-guidance-documents

• Cover letter table template (MRP/DCP): http://www.hma.eu/219.html

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