{
  "data": {
    "id": "stat_TVS8NZ8FRH1ZBBSQJ144G7R723",
    "url": "https://statorigin.org/stat/stat_TVS8NZ8FRH1ZBBSQJ144G7R723",
    "indicator": {
      "slug": "new-active-substance-approvals",
      "name": "New active substance approvals",
      "definition": "Total count of new active substance marketing approvals granted by regulatory authorities during the period."
    },
    "industry": [
      {
        "slug": "pharmaceuticals",
        "name": "Manufacture of basic pharmaceutical products and pharmaceutical preparations",
        "isic": "C21",
        "is_primary": true
      }
    ],
    "region": {
      "code": "EU",
      "name": "European Union",
      "type": "bloc"
    },
    "period": {
      "start": "2025-01-01",
      "end": "2025-12-31",
      "type": "year"
    },
    "value": 39,
    "value_text": "39",
    "unit": "count",
    "currency": null,
    "scale": "1",
    "value_type": "actual",
    "source": {
      "org": "Centre for Innovation in Regulatory Science",
      "org_short_name": "CIRS",
      "org_url": "https://cirsci.org",
      "org_tier": 3,
      "document_title": "New Drug Approvals by Six Major Authorities 2016-2025",
      "document_url": "https://cirsci.org/publications/cirs-rd-briefing-106-new-drug-approvals-by-six-major-authorities-2016-2025/",
      "document_type": "press_release",
      "locator": "Key Findings",
      "quote": "In 2025, FDA granted the highest number of new active substance approvals (50), followed by Health Canada (44), TGA (42), PMDA (40), EMA (39), and Swissmedic (34).",
      "published_date": null,
      "accessed_at": "2026-09-17",
      "license": "see-source",
      "url_status": "ok"
    },
    "verification": "verified",
    "verified_by": "seed:auto-extract-v1",
    "verified_at": "2026-09-17T16:36:08.269Z",
    "confidence": 0.9,
    "is_secondhand": false,
    "supersedes": null,
    "superseded_by": null,
    "is_current": true,
    "citation": {
      "apa": "Centre for Innovation in Regulatory Science. (2025). New Drug Approvals by Six Major Authorities 2016-2025. Retrieved September 17, 2026, from https://cirsci.org/publications/cirs-rd-briefing-106-new-drug-approvals-by-six-major-authorities-2016-2025/. Via StatOrigin, https://statorigin.org/stat/stat_TVS8NZ8FRH1ZBBSQJ144G7R723",
      "bibtex": "@misc{cirs2025activeg7r723,\n  author       = {{Centre for Innovation in Regulatory Science}},\n  title        = {New Drug Approvals by Six Major Authorities 2016-2025},\n  year         = {2025},\n  howpublished = {StatOrigin, https://statorigin.org},\n  url          = {https://statorigin.org/stat/stat_TVS8NZ8FRH1ZBBSQJ144G7R723},\n  note         = {Original source: https://cirsci.org/publications/cirs-rd-briefing-106-new-drug-approvals-by-six-major-authorities-2016-2025/. Accessed September 17, 2026.}\n}"
    },
    "updated_at": "2026-09-17T16:36:08.269Z",
    "contested_by": [],
    "related": []
  },
  "meta": {
    "attribution": "Data from StatOrigin (https://statorigin.org), CC BY 4.0. Attribution required.",
    "license": "https://creativecommons.org/licenses/by/4.0/",
    "docs": "https://statorigin.org/docs/api",
    "total": 1
  }
}