What ICH M4 - Common Technical Document (CTD): 5-Module Structure for Global Regulatory Submissions (2002) requires
ICH M4 (Step 4, 2001-2004) defines the 5-module Common Technical Document format - the universal standard for marketing authorisation applications in EU, US, Japan, Canada, and all ICH Member jurisdictions - covering administrative data (Module 1), quality summaries (Module 2), quality/CMC (Module 3), non-clinical reports (Module 4), and clinical study reports (Module 5), implemented as eCTD electronic submission.
Pillar: Pharmaceuticals & Life Sciences · Authority: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) · Version: 1.0.0 · Last updated:
Primary source: https://www.ich.org/products/ctd.html
SHA-256 integrity: 35552f11970b650668cf9b1c8161586d47b82d7ff6bae1943f1188b270128bb1
Primary Citations — 6 traced to source
- {"title":"ICH M4 - Organisation of the Common Technical Document for the Registration of Pharmaceuticals for Human Use (CTD)","url":"https://www.ich.org/products/ctd.html","instrument":"ICH M4","jurisdiction":"International"}
- {"title":"ICH M4Q(R1) - Common Technical Document: Quality (2002)","url":"https://www.ich.org/products/guidelines/multidisciplinary/article/m4q.html","instrument":"ICH M4Q(R1)","jurisdiction":"International"}
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