CRED ERP 25

01/07/2025

References/sources

• Demonstrating significant benefit of orphan medicines: analysis of 15 years of experience in Europe: https://www.sciencedirect.com/science/article/pii/S1359644617301599 • EMA QRD product template: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_00 0134.jsp&mid=WC0b01ac0580022c59 • Product Information CMDh annotated template: http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/QRD/CMDh_201_2005_Rev 9_2016_02_clean.pdf

• Notice to Applicants Volume 2A, Chpt. 1: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-2/vol2a_chap1_en.pdf

• CHMP Note for Guidance on inclusion of appendices in clinical study reports in MAAs: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003638.p df

The Organisation for Professionals in Regulatory Affairs

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