{
  "node_id": "pharmacovigilance-ich-e2e-2026",
  "title": "ICH E2E Pharmacovigilance Planning & Global Pharmacovigilance Obligations (2026)",
  "domain": "Medical & Healthcare",
  "version": "1.0.0",
  "last_updated": "2026-05-20",
  "bluf": "ICH E2E and related guidelines establish international standards for pharmacovigilance planning, risk management plans (RMPs), signal detection, periodic benefit-risk evaluation reports (PBRERs), and post-authorisation safety studies. Manufacturers and marketing authorisation holders must maintain robust pharmacovigilance systems, including global safety databases and timely reporting of adverse events.",
  "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": [
    "ich-e6-r3-gcp-2026"
  ],
  "primary_citations_count": 4
}