{
  "node_id": "eu-paediatric-regulation-1901-2006-pharma",
  "title": "Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004",
  "domain": "Pharmaceuticals & Life Sciences",
  "version": "1.0.1",
  "last_updated": "2026-04-30",
  "bluf": "This regulation mandates that pharmaceutical developers submit a Paediatric Investigation Plan (PIP) to the European Medicines Agency's Paediatric Committee (PDCO) before initiating clinical trials for new medicines…",
  "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": [
    "fda-21-cfr-part-312-ind-investigational-new-drug",
    "fda-21-cfr-part-314-nda-new-drug-application",
    "fda-biosimilar-pathway-351k-biologics-competition-act",
    "ich-q10-pharmaceutical-quality-system-2008"
  ],
  "primary_citations_count": 5,
  "workflow_steps_count": 10,
  "schema_fields_count": 10,
  "citation_preview": [
    "Regulation (EC) No 1901/2006, Article 7 - Submission of Paediatric Investigation Plan (PIP)",
    "Regulation (EC) No 1901/2006, Article 8 - Opinion of the Paediatric Committee (PDCO)"
  ]
}