{
  "node_id": "eu-atmp-regulation-1394-2007",
  "title": "Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on Advanced Therapy Medicinal Products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004",
  "domain": "Biotech & Genomics",
  "version": "1.0.0",
  "last_updated": "2026-04-20",
  "bluf": "This regulation establishes a centralized authorization procedure for advanced therapy medicinal products (ATMPs), including gene therapy, somatic cell therapy, and tissue-engineered products, within the European Union. It applies to manufacturers, sponsors, and marketing authorization holders of ATMPs under Article 8 and requires compliance with specific quality, safety, and efficacy standards.",
  "paywall": {
    "status": "LOCKED",
    "unlock_cost_usd": "0.01",
    "skyfire_id": "41779894-ece2-4163-9761-b3b1b76e19b0"
  },
  "crosswalks": {
    "_available_keys": [
      "nist_framework",
      "iso_standard",
      "industry_mapping",
      "ai_overlay_2026"
    ],
    "_note": "Full crosswalk values included in vault response"
  },
  "dependencies": [
    "iso-13485-qms",
    "ich-gcp-e6-r3-2023"
  ],
  "primary_citations_count": 5
}