{
  "node_id": "ich-m4-common-technical-document-2002",
  "title": "ICH M4 - Common Technical Document (CTD): 5-Module Structure for Global Regulatory Submissions (2002)",
  "domain": "Pharmaceuticals & Life Sciences",
  "version": "1.0.0",
  "last_updated": "2016-11-01",
  "bluf": "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.",
  "paywall": {
    "status": "LOCKED",
    "unlock_cost_usd": "0.01",
    "skyfire_id": "41779894-ece2-4163-9761-b3b1b76e19b0"
  },
  "crosswalks": {
    "_available_keys": [
      "eu_ai_act",
      "nist_csf",
      "iso_standard",
      "industry_mapping"
    ],
    "_note": "Full crosswalk values included in vault response"
  },
  "dependencies": [
    "ich-q14-analytical-procedure-development-2023",
    "ich-e6-r3-good-clinical-practice-pharma-2023"
  ],
  "primary_citations_count": 6
}