Module 5 Presentations

05/07/2024

CT Regulation (536/2014) Requirements

• IMPD requirements outlined Annex 1, section G • GMP documentation requirements Annex 1, section F – MIA required enclosure – QP declaration for 3 rd countries – GMP certs not specifically requested (EudraGMP) – Evidence sites are permitted to perform basic tasks required (re-labelling, radiopharma prep, per patient drugs, etc.)* – Addition of the Aux. med dossier as a formal requirement • CT Dir. 2001/20/EC and related requirements apply to studies submitted under it

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General Structure

• “Logical structure” (CTD, mod 2) • Detailed table of contents and glossary of terms necessary, each section • IMPD to be concise – MHRA previously advised aiming for ~100 pages • Tables preferred to verbiage. Brief narrative text of main points • Per section versioning, or at least general versioning recommended • Dossier, not document • TOC and Glossary • Bookmarks to key headers • No document security

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