{
  "schema_version": 1,
  "collection": "instruments",
  "generated_at": "2026-07-28T22:39:15.133Z",
  "source": "https://gxplex.com",
  "license": "https://creativecommons.org/licenses/by/4.0/",
  "notice": "Reports the published status of regulatory documents. No advice or interpretation.",
  "count": 69,
  "items": [
    {
      "id": "anvisa-ai",
      "title": "ANVISA positions on computerised systems and artificial intelligence",
      "short_title": "ANVISA",
      "authority": "Agência Nacional de Vigilância Sanitária",
      "jurisdiction": "Other",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": null,
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://www.gov.br/anvisa/pt-br/assuntos/regulamentacao",
      "secondary_urls": [],
      "topics": [
        "computerised systems",
        "artificial intelligence"
      ],
      "summary": "Brazilian health regulatory agency publications addressing computerised systems and artificial intelligence.",
      "watch_cadence": "quarterly",
      "url": "https://gxplex.com/instrument/anvisa-ai"
    },
    {
      "id": "astm-e2363",
      "title": "ASTM E2363 — Terminology relating to process analytical technology",
      "short_title": "ASTM E2363",
      "authority": "ASTM International",
      "jurisdiction": "International",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": "2023-02-23",
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://www.astm.org/e2363-14.html",
      "secondary_urls": [],
      "topics": [
        "terminology"
      ],
      "summary": "Standard terminology relating to process analytical technology in the pharmaceutical industry.",
      "watch_cadence": "quarterly",
      "url": "https://gxplex.com/instrument/astm-e2363"
    },
    {
      "id": "astm-e2500",
      "title": "ASTM E2500 — Specification, design and verification of manufacturing systems",
      "short_title": "ASTM E2500",
      "authority": "ASTM International",
      "jurisdiction": "International",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": "2025-04-01",
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://www.astm.org/e2500-20.html",
      "secondary_urls": [],
      "topics": [
        "verification",
        "manufacturing systems"
      ],
      "summary": "Standard guide for the specification, design and verification of pharmaceutical and biopharmaceutical manufacturing systems and equipment.",
      "watch_cadence": "quarterly",
      "url": "https://gxplex.com/instrument/astm-e2500"
    },
    {
      "id": "cen-jtc21-programme",
      "title": "CEN/CENELEC JTC 21 work programme",
      "short_title": "CEN/CLC JTC 21",
      "authority": "CEN/CENELEC",
      "jurisdiction": "EU",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": null,
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/",
      "secondary_urls": [],
      "topics": [
        "work programme",
        "standardisation"
      ],
      "summary": "Published work programme of the CEN/CENELEC technical committee developing European standards in support of the EU AI Act.",
      "watch_cadence": "monthly",
      "url": "https://gxplex.com/instrument/cen-jtc21-programme"
    },
    {
      "id": "easa-ai-roadmap",
      "title": "EASA Artificial Intelligence Roadmap and guidance",
      "short_title": "EASA AI",
      "authority": "European Union Aviation Safety Agency",
      "jurisdiction": "EU",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": "2024-05-31",
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://www.easa.europa.eu/en/domains/research-innovation/ai",
      "secondary_urls": [],
      "topics": [],
      "summary": "EASA publications addressing the use of artificial intelligence in aviation, including concept papers and guidance.",
      "watch_cadence": "quarterly",
      "url": "https://gxplex.com/instrument/easa-ai-roadmap"
    },
    {
      "id": "efsa-ai",
      "title": "EFSA outputs on data and computational methods",
      "short_title": "EFSA",
      "authority": "European Food Safety Authority",
      "jurisdiction": "EU",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": "2026-07-27",
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://www.efsa.europa.eu/en/publications",
      "secondary_urls": [],
      "topics": [
        "data",
        "computational methods"
      ],
      "summary": "European Food Safety Authority publications addressing data handling and computational methods in risk assessment.",
      "watch_cadence": "quarterly",
      "url": "https://gxplex.com/instrument/efsa-ai"
    },
    {
      "id": "ema-ai-reflection",
      "title": "EMA reflection paper on the use of artificial intelligence in the medicinal product lifecycle",
      "short_title": "EMA AI reflection paper",
      "authority": "European Medicines Agency",
      "jurisdiction": "EU",
      "status": "final",
      "status_qualifier": null,
      "status_as_of": "2023-11-21",
      "last_verified": "2026-07-28",
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://www.ema.europa.eu/en/use-artificial-intelligence-ai-medicinal-product-lifecycle",
      "secondary_urls": [],
      "topics": [
        "artificial intelligence",
        "medicinal products"
      ],
      "summary": "EMA reflection paper addressing the use of artificial intelligence across the medicinal product lifecycle.",
      "watch_cadence": "monthly",
      "url": "https://gxplex.com/instrument/ema-ai-reflection"
    },
    {
      "id": "ema-qig",
      "title": "EMA Quality Innovation Group",
      "short_title": "EMA QIG",
      "authority": "European Medicines Agency",
      "jurisdiction": "EU",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": "2026-03-18",
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp/quality-innovation-group",
      "secondary_urls": [],
      "topics": [
        "innovation",
        "quality"
      ],
      "summary": "EMA group publishing outputs on quality-related innovation, including listen-and-learn focus groups and Q&A documents.",
      "watch_cadence": "monthly",
      "url": "https://gxplex.com/instrument/ema-qig"
    },
    {
      "id": "ema-work-programme",
      "title": "EMA work programme and planning documents",
      "short_title": "EMA work programme",
      "authority": "European Medicines Agency",
      "jurisdiction": "EU",
      "status": "final",
      "status_qualifier": null,
      "status_as_of": null,
      "last_verified": "2026-07-28",
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://www.ema.europa.eu/en/about-us/how-we-work/planning-reporting",
      "secondary_urls": [],
      "topics": [
        "work programme",
        "planning"
      ],
      "summary": "EMA planning and reporting documents setting out the agency's programme of work for the period.",
      "watch_cadence": "quarterly",
      "url": "https://gxplex.com/instrument/ema-work-programme"
    },
    {
      "id": "eu-ai-act",
      "title": "Regulation (EU) 2024/1689 — Artificial Intelligence Act",
      "short_title": "EU AI Act",
      "authority": "European Parliament and Council",
      "jurisdiction": "EU",
      "status": "in-force",
      "status_qualifier": null,
      "status_as_of": "2028-08-02",
      "last_verified": "2026-07-28",
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://eur-lex.europa.eu/eli/reg/2024/1689/oj",
      "secondary_urls": [],
      "topics": [
        "artificial intelligence",
        "risk classification",
        "conformity assessment"
      ],
      "summary": "Regulation establishing harmonised rules on artificial intelligence, including obligations for high-risk AI systems, applied on a phased timetable.",
      "watch_cadence": "weekly",
      "url": "https://gxplex.com/instrument/eu-ai-act"
    },
    {
      "id": "eu-gmp-annex-11",
      "title": "EudraLex Volume 4, Annex 11 — Computerised Systems",
      "short_title": "EU GMP Annex 11",
      "authority": "European Commission",
      "jurisdiction": "EU",
      "status": "withdrawn",
      "status_qualifier": null,
      "status_as_of": "2018-05-22",
      "last_verified": "2026-07-28",
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en",
      "secondary_urls": [],
      "topics": [
        "computerised systems",
        "GMP",
        "electronic records"
      ],
      "summary": "Annex to the EU GMP guide addressing computerised systems used in regulated manufacturing. A revision has been under public consultation.",
      "watch_cadence": "weekly",
      "url": "https://gxplex.com/instrument/eu-gmp-annex-11"
    },
    {
      "id": "eu-gmp-annex-22",
      "title": "EudraLex Volume 4, Annex 22 — Artificial Intelligence",
      "short_title": "EU GMP Annex 22",
      "authority": "European Commission",
      "jurisdiction": "EU",
      "status": "withdrawn",
      "status_qualifier": null,
      "status_as_of": "2018-05-22",
      "last_verified": "2026-07-28",
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en",
      "secondary_urls": [],
      "topics": [
        "artificial intelligence",
        "GMP"
      ],
      "summary": "Proposed GMP annex addressing the use of artificial intelligence in regulated manufacturing operations.",
      "watch_cadence": "weekly",
      "url": "https://gxplex.com/instrument/eu-gmp-annex-22"
    },
    {
      "id": "eu-ivdr",
      "title": "Regulation (EU) 2017/746 on in vitro diagnostic medical devices",
      "short_title": "EU IVDR",
      "authority": "European Parliament and Council",
      "jurisdiction": "EU",
      "status": "in-force",
      "status_qualifier": null,
      "status_as_of": "2022-02-25",
      "last_verified": "2026-07-28",
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://eur-lex.europa.eu/eli/reg/2017/746/oj",
      "secondary_urls": [],
      "topics": [],
      "summary": "EU regulation on in vitro diagnostic medical devices.",
      "watch_cadence": "quarterly",
      "url": "https://gxplex.com/instrument/eu-ivdr"
    },
    {
      "id": "eu-mdr",
      "title": "Regulation (EU) 2017/745 on medical devices",
      "short_title": "EU MDR",
      "authority": "European Parliament and Council",
      "jurisdiction": "EU",
      "status": "in-force",
      "status_qualifier": null,
      "status_as_of": "2020-05-26",
      "last_verified": "2026-07-28",
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://eur-lex.europa.eu/eli/reg/2017/745/oj",
      "secondary_urls": [],
      "topics": [],
      "summary": "EU regulation on medical devices, including requirements applying to software as a medical device.",
      "watch_cadence": "quarterly",
      "url": "https://gxplex.com/instrument/eu-mdr"
    },
    {
      "id": "eu-reach",
      "title": "Regulation (EC) 1907/2006 — REACH",
      "short_title": "EU REACH",
      "authority": "European Chemicals Agency",
      "jurisdiction": "EU",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": null,
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://echa.europa.eu/regulations/reach/legislation",
      "secondary_urls": [],
      "topics": [
        "chemicals",
        "registration"
      ],
      "summary": "EU regulation on the registration, evaluation, authorisation and restriction of chemicals.",
      "watch_cadence": "quarterly",
      "url": "https://gxplex.com/instrument/eu-reach"
    },
    {
      "id": "fda-ai-guidance",
      "title": "Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products",
      "short_title": "FDA AI guidance",
      "authority": "US Food and Drug Administration",
      "jurisdiction": "US",
      "status": "final",
      "status_qualifier": null,
      "status_as_of": null,
      "last_verified": "2026-07-28",
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents",
      "secondary_urls": [],
      "topics": [
        "artificial intelligence",
        "credibility assessment"
      ],
      "summary": "FDA draft guidance describing a risk-based credibility assessment framework for AI models used to support regulatory decision-making.",
      "watch_cadence": "weekly",
      "url": "https://gxplex.com/instrument/fda-ai-guidance"
    },
    {
      "id": "fda-aiml-device-list",
      "title": "FDA list of AI-enabled medical devices with marketing authorisation",
      "short_title": "FDA AI device list",
      "authority": "US Food and Drug Administration",
      "jurisdiction": "US",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": null,
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices",
      "secondary_urls": [],
      "topics": [
        "artificial intelligence",
        "medical devices",
        "authorisation"
      ],
      "summary": "A dated and periodically extended list of artificial-intelligence-enabled medical devices that have received FDA marketing authorisation.",
      "watch_cadence": "monthly",
      "url": "https://gxplex.com/instrument/fda-aiml-device-list"
    },
    {
      "id": "fda-cdrh-aiml",
      "title": "FDA guidance on AI-enabled device software functions",
      "short_title": "FDA CDRH AI/ML",
      "authority": "US Food and Drug Administration",
      "jurisdiction": "US",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": null,
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://www.fda.gov/medical-devices/software-medical-device-samd",
      "secondary_urls": [],
      "topics": [],
      "summary": "FDA guidance addressing artificial-intelligence-enabled device software functions and predetermined change control plans.",
      "watch_cadence": "monthly",
      "url": "https://gxplex.com/instrument/fda-cdrh-aiml"
    },
    {
      "id": "fda-csa",
      "title": "Computer Software Assurance for Production and Quality System Software",
      "short_title": "FDA CSA",
      "authority": "US Food and Drug Administration",
      "jurisdiction": "US",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": null,
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/computer-software-assurance-production-and-quality-system-software",
      "secondary_urls": [],
      "topics": [
        "software assurance",
        "validation"
      ],
      "summary": "FDA guidance addressing assurance activities for computer software used in production and quality systems.",
      "watch_cadence": "weekly",
      "url": "https://gxplex.com/instrument/fda-csa"
    },
    {
      "id": "fda-data-integrity",
      "title": "Data Integrity and Compliance With Drug CGMP — Questions and Answers",
      "short_title": "FDA data integrity",
      "authority": "US Food and Drug Administration",
      "jurisdiction": "US",
      "status": "final",
      "status_qualifier": null,
      "status_as_of": null,
      "last_verified": "2026-07-28",
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-integrity-and-compliance-drug-cgmp-questions-and-answers",
      "secondary_urls": [],
      "topics": [
        "data integrity",
        "CGMP",
        "electronic records"
      ],
      "summary": "FDA guidance in question-and-answer form addressing data integrity expectations under the drug CGMP regulations.",
      "watch_cadence": "monthly",
      "url": "https://gxplex.com/instrument/fda-data-integrity"
    },
    {
      "id": "fda-dhcoe",
      "title": "FDA Digital Health Center of Excellence",
      "short_title": "FDA DHCoE",
      "authority": "US Food and Drug Administration",
      "jurisdiction": "US",
      "status": "draft",
      "status_qualifier": "under consultation",
      "status_as_of": null,
      "last_verified": "2026-07-28",
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://www.fda.gov/medical-devices/digital-health-center-excellence",
      "secondary_urls": [],
      "topics": [
        "digital health",
        "software"
      ],
      "summary": "FDA centre publishing outputs on digital health technologies, including software and artificial intelligence in medical devices.",
      "watch_cadence": "monthly",
      "url": "https://gxplex.com/instrument/fda-dhcoe"
    },
    {
      "id": "fda-etp",
      "title": "FDA Emerging Technology Program",
      "short_title": "FDA ETP",
      "authority": "US Food and Drug Administration",
      "jurisdiction": "US",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": null,
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/emerging-technology-program",
      "secondary_urls": [],
      "topics": [
        "emerging technology"
      ],
      "summary": "CDER programme through which companies may discuss novel technology with the agency ahead of a regulatory submission.",
      "watch_cadence": "monthly",
      "url": "https://gxplex.com/instrument/fda-etp"
    },
    {
      "id": "fda-guidance-agenda",
      "title": "FDA CDER Guidance Agenda",
      "short_title": "FDA guidance agenda",
      "authority": "US Food and Drug Administration",
      "jurisdiction": "US",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": null,
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://www.fda.gov/drugs/guidances-drugs/guidance-agenda-new-and-revised-draft-guidances-cder-plans-publish-during-calendar-year",
      "secondary_urls": [],
      "topics": [
        "guidance pipeline"
      ],
      "summary": "Annual list of new and revised draft guidances CDER plans to publish during the calendar year.",
      "watch_cadence": "monthly",
      "url": "https://gxplex.com/instrument/fda-guidance-agenda"
    },
    {
      "id": "fda-pccp",
      "title": "Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions",
      "short_title": "FDA PCCP",
      "authority": "US Food and Drug Administration",
      "jurisdiction": "US",
      "status": "final",
      "status_qualifier": null,
      "status_as_of": null,
      "last_verified": "2026-07-28",
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence",
      "secondary_urls": [],
      "topics": [
        "artificial intelligence",
        "change control",
        "software"
      ],
      "summary": "FDA guidance on predetermined change control plans for artificial-intelligence-enabled device software functions.",
      "watch_cadence": "monthly",
      "url": "https://gxplex.com/instrument/fda-pccp"
    },
    {
      "id": "health-canada-ml",
      "title": "Health Canada guidance on machine learning medical devices",
      "short_title": "Health Canada ML",
      "authority": "Health Canada",
      "jurisdiction": "Other",
      "status": "draft",
      "status_qualifier": "under consultation",
      "status_as_of": "2025-02-20",
      "last_verified": "2026-07-28",
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices.html",
      "secondary_urls": [],
      "topics": [],
      "summary": "Health Canada guidance addressing machine-learning-enabled medical devices.",
      "watch_cadence": "quarterly",
      "url": "https://gxplex.com/instrument/health-canada-ml"
    },
    {
      "id": "iaea-digital",
      "title": "IAEA guidance on digital instrumentation and control",
      "short_title": "IAEA digital I&C",
      "authority": "International Atomic Energy Agency",
      "jurisdiction": "International",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": null,
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://www.iaea.org/publications",
      "secondary_urls": [],
      "topics": [
        "instrumentation and control",
        "software"
      ],
      "summary": "IAEA safety standards and technical publications addressing digital instrumentation, control and software in nuclear facilities.",
      "watch_cadence": "quarterly",
      "url": "https://gxplex.com/instrument/iaea-digital"
    },
    {
      "id": "ich-e6r3",
      "title": "ICH E6(R3) — Good Clinical Practice",
      "short_title": "ICH E6(R3)",
      "authority": "International Council for Harmonisation",
      "jurisdiction": "International",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": null,
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://ich.org/page/efficacy-guidelines",
      "secondary_urls": [],
      "topics": [
        "good clinical practice",
        "data governance"
      ],
      "summary": "ICH guideline on good clinical practice, revised to address data governance and computerised systems in trials.",
      "watch_cadence": "quarterly",
      "url": "https://gxplex.com/instrument/ich-e6r3"
    },
    {
      "id": "ich-q10",
      "title": "ICH Q10 — Pharmaceutical Quality System",
      "short_title": "ICH Q10",
      "authority": "International Council for Harmonisation",
      "jurisdiction": "International",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": null,
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://ich.org/page/quality-guidelines",
      "secondary_urls": [],
      "topics": [
        "quality system"
      ],
      "summary": "ICH guideline describing a model for a pharmaceutical quality system applicable across the product lifecycle.",
      "watch_cadence": "quarterly",
      "url": "https://gxplex.com/instrument/ich-q10"
    },
    {
      "id": "ich-q11",
      "title": "ICH Q11 — Development and Manufacture of Drug Substances",
      "short_title": "ICH Q11",
      "authority": "International Council for Harmonisation",
      "jurisdiction": "International",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": null,
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://ich.org/page/quality-guidelines",
      "secondary_urls": [],
      "topics": [
        "quality guideline"
      ],
      "summary": "ICH quality guideline in the Q-series, addressing development and manufacture.",
      "watch_cadence": "quarterly",
      "url": "https://gxplex.com/instrument/ich-q11"
    },
    {
      "id": "ich-q12",
      "title": "ICH Q12 — Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management",
      "short_title": "ICH Q12",
      "authority": "International Council for Harmonisation",
      "jurisdiction": "International",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": null,
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://ich.org/page/quality-guidelines",
      "secondary_urls": [],
      "topics": [
        "lifecycle management",
        "established conditions"
      ],
      "summary": "ICH guideline introducing established conditions and post-approval change management protocols for lifecycle management.",
      "watch_cadence": "quarterly",
      "url": "https://gxplex.com/instrument/ich-q12"
    },
    {
      "id": "ich-q13",
      "title": "ICH Q13 — Continuous Manufacturing of Drug Substances and Drug Products",
      "short_title": "ICH Q13",
      "authority": "International Council for Harmonisation",
      "jurisdiction": "International",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": null,
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://ich.org/page/quality-guidelines",
      "secondary_urls": [],
      "topics": [
        "continuous manufacturing"
      ],
      "summary": "ICH guideline addressing scientific and regulatory considerations for continuous manufacturing.",
      "watch_cadence": "quarterly",
      "url": "https://gxplex.com/instrument/ich-q13"
    },
    {
      "id": "ich-q14",
      "title": "ICH Q14 — Analytical Procedure Development",
      "short_title": "ICH Q14",
      "authority": "International Council for Harmonisation",
      "jurisdiction": "International",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": null,
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://ich.org/page/quality-guidelines",
      "secondary_urls": [],
      "topics": [
        "analytical procedures"
      ],
      "summary": "ICH guideline on the development of analytical procedures, adopted alongside the ICH Q2(R2) revision.",
      "watch_cadence": "quarterly",
      "url": "https://gxplex.com/instrument/ich-q14"
    },
    {
      "id": "ich-q2r2",
      "title": "ICH Q2(R2) — Validation of Analytical Procedures",
      "short_title": "ICH Q2(R2)",
      "authority": "International Council for Harmonisation",
      "jurisdiction": "International",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": null,
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://ich.org/page/quality-guidelines",
      "secondary_urls": [],
      "topics": [
        "analytical procedures",
        "validation"
      ],
      "summary": "ICH guideline on the validation of analytical procedures, revised alongside ICH Q14.",
      "watch_cadence": "quarterly",
      "url": "https://gxplex.com/instrument/ich-q2r2"
    },
    {
      "id": "ich-q8",
      "title": "ICH Q8(R2) — Pharmaceutical Development",
      "short_title": "ICH Q8",
      "authority": "International Council for Harmonisation",
      "jurisdiction": "International",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": null,
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://ich.org/page/quality-guidelines",
      "secondary_urls": [],
      "topics": [
        "pharmaceutical development"
      ],
      "summary": "ICH guideline on pharmaceutical development, including the design space concept.",
      "watch_cadence": "quarterly",
      "url": "https://gxplex.com/instrument/ich-q8"
    },
    {
      "id": "ich-q9r1",
      "title": "ICH Q9(R1) — Quality Risk Management",
      "short_title": "ICH Q9(R1)",
      "authority": "International Council for Harmonisation",
      "jurisdiction": "International",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": null,
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://ich.org/page/quality-guidelines",
      "secondary_urls": [],
      "topics": [
        "quality risk management"
      ],
      "summary": "ICH guideline on quality risk management, revised to address subjectivity, formality and risk-based decision-making.",
      "watch_cadence": "quarterly",
      "url": "https://gxplex.com/instrument/ich-q9r1"
    },
    {
      "id": "ieee-7000",
      "title": "IEEE 7000 series — Ethical and systems standards for AI",
      "short_title": "IEEE 7000",
      "authority": "Institute of Electrical and Electronics Engineers",
      "jurisdiction": "International",
      "status": "withdrawn",
      "status_qualifier": null,
      "status_as_of": "2016-06-30",
      "last_verified": "2026-07-28",
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://standards.ieee.org/ieee/7000/6781/",
      "secondary_urls": [],
      "topics": [
        "ethics",
        "systems engineering"
      ],
      "summary": "Series of IEEE standards addressing ethical and systems considerations in the design of autonomous and intelligent systems.",
      "watch_cadence": "quarterly",
      "url": "https://gxplex.com/instrument/ieee-7000"
    },
    {
      "id": "imdrf-aiml-wg",
      "title": "IMDRF artificial intelligence working group outputs",
      "short_title": "IMDRF AI/ML WG",
      "authority": "International Medical Device Regulators Forum",
      "jurisdiction": "International",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": null,
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://www.imdrf.org/working-groups",
      "secondary_urls": [],
      "topics": [
        "artificial intelligence",
        "medical devices"
      ],
      "summary": "Outputs of the IMDRF working group addressing artificial intelligence and machine learning in medical devices.",
      "watch_cadence": "quarterly",
      "url": "https://gxplex.com/instrument/imdrf-aiml-wg"
    },
    {
      "id": "imdrf-samd",
      "title": "IMDRF Software as a Medical Device documents",
      "short_title": "IMDRF SaMD",
      "authority": "International Medical Device Regulators Forum",
      "jurisdiction": "International",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": null,
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://www.imdrf.org/documents",
      "secondary_urls": [],
      "topics": [],
      "summary": "Documents published by IMDRF addressing software as a medical device and machine learning.",
      "watch_cadence": "quarterly",
      "url": "https://gxplex.com/instrument/imdrf-samd"
    },
    {
      "id": "iso-iec-22989",
      "title": "ISO/IEC 22989 — Artificial intelligence concepts and terminology",
      "short_title": "ISO/IEC 22989",
      "authority": "ISO/IEC",
      "jurisdiction": "International",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": null,
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://www.iso.org/standard/74296.html",
      "secondary_urls": [],
      "topics": [
        "terminology",
        "artificial intelligence"
      ],
      "summary": "Standard establishing terminology and concepts for artificial intelligence.",
      "watch_cadence": "quarterly",
      "url": "https://gxplex.com/instrument/iso-iec-22989"
    },
    {
      "id": "iso-iec-23894",
      "title": "ISO/IEC 23894 — AI guidance on risk management",
      "short_title": "ISO/IEC 23894",
      "authority": "ISO/IEC",
      "jurisdiction": "International",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": null,
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://www.iso.org/standard/77304.html",
      "secondary_urls": [],
      "topics": [],
      "summary": "International standard providing guidance on risk management for artificial intelligence.",
      "watch_cadence": "quarterly",
      "url": "https://gxplex.com/instrument/iso-iec-23894"
    },
    {
      "id": "iso-iec-24028",
      "title": "ISO/IEC 24028 — Overview of trustworthiness in artificial intelligence",
      "short_title": "ISO/IEC 24028",
      "authority": "ISO/IEC",
      "jurisdiction": "International",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": "2023-09-11",
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://www.iso.org/committee/6794475.html",
      "secondary_urls": [],
      "topics": [
        "trustworthiness",
        "artificial intelligence"
      ],
      "summary": "Technical report giving an overview of trustworthiness in artificial intelligence systems.",
      "watch_cadence": "quarterly",
      "url": "https://gxplex.com/instrument/iso-iec-24028"
    },
    {
      "id": "iso-iec-38507",
      "title": "ISO/IEC 38507 — Governance implications of the use of AI",
      "short_title": "ISO/IEC 38507",
      "authority": "ISO/IEC",
      "jurisdiction": "International",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": "2023-09-11",
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://www.iso.org/committee/6794475.html",
      "secondary_urls": [],
      "topics": [
        "governance",
        "artificial intelligence"
      ],
      "summary": "Standard addressing the governance implications of organisational use of artificial intelligence.",
      "watch_cadence": "quarterly",
      "url": "https://gxplex.com/instrument/iso-iec-38507"
    },
    {
      "id": "iso-iec-42001",
      "title": "ISO/IEC 42001 — Artificial intelligence management system",
      "short_title": "ISO/IEC 42001",
      "authority": "ISO/IEC",
      "jurisdiction": "International",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": null,
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://www.iso.org/standard/81230.html",
      "secondary_urls": [],
      "topics": [
        "management system",
        "artificial intelligence"
      ],
      "summary": "International standard specifying requirements for establishing and maintaining an artificial intelligence management system.",
      "watch_cadence": "quarterly",
      "url": "https://gxplex.com/instrument/iso-iec-42001"
    },
    {
      "id": "iso-iec-42005",
      "title": "ISO/IEC 42005 — AI system impact assessment",
      "short_title": "ISO/IEC 42005",
      "authority": "ISO/IEC",
      "jurisdiction": "International",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": "2023-09-11",
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://www.iso.org/committee/6794475.html",
      "secondary_urls": [],
      "topics": [
        "impact assessment",
        "artificial intelligence"
      ],
      "summary": "Standard addressing impact assessment for artificial intelligence systems.",
      "watch_cadence": "quarterly",
      "url": "https://gxplex.com/instrument/iso-iec-42005"
    },
    {
      "id": "iso-iec-5259",
      "title": "ISO/IEC 5259 series — Data quality for analytics and machine learning",
      "short_title": "ISO/IEC 5259",
      "authority": "ISO/IEC",
      "jurisdiction": "International",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": "2023-09-11",
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://www.iso.org/committee/6794475.html",
      "secondary_urls": [],
      "topics": [
        "data quality",
        "machine learning"
      ],
      "summary": "Multi-part standard series addressing data quality for analytics and machine learning.",
      "watch_cadence": "quarterly",
      "url": "https://gxplex.com/instrument/iso-iec-5259"
    },
    {
      "id": "iso-iec-sc42-programme",
      "title": "ISO/IEC JTC 1/SC 42 work programme",
      "short_title": "ISO/IEC SC 42",
      "authority": "ISO/IEC",
      "jurisdiction": "International",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": "2023-09-11",
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://www.iso.org/committee/6794475.html",
      "secondary_urls": [],
      "topics": [
        "work programme",
        "standardisation"
      ],
      "summary": "Published work programme of the ISO/IEC subcommittee responsible for artificial intelligence standards, listing projects and their stage codes.",
      "watch_cadence": "monthly",
      "url": "https://gxplex.com/instrument/iso-iec-sc42-programme"
    },
    {
      "id": "ispe-gamp-ai",
      "title": "ISPE GAMP Guide: Artificial Intelligence",
      "short_title": "GAMP AI Guide",
      "authority": "ISPE",
      "jurisdiction": "International",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": null,
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://ispe.org/publications/guidance-documents",
      "secondary_urls": [],
      "topics": [
        "artificial intelligence",
        "computerised systems"
      ],
      "summary": "Industry guide published by ISPE addressing artificial intelligence within the GAMP framework.",
      "watch_cadence": "quarterly",
      "url": "https://gxplex.com/instrument/ispe-gamp-ai"
    },
    {
      "id": "ispe-gamp5-2e",
      "title": "ISPE GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition)",
      "short_title": "GAMP 5 2nd Ed",
      "authority": "ISPE",
      "jurisdiction": "International",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": null,
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://ispe.org/publications/guidance-documents/gamp-5-guide-2nd-edition",
      "secondary_urls": [],
      "topics": [
        "computerised systems",
        "software categories"
      ],
      "summary": "Industry guide published by ISPE addressing computerised systems in regulated environments.",
      "watch_cadence": "quarterly",
      "url": "https://gxplex.com/instrument/ispe-gamp5-2e"
    },
    {
      "id": "ispe-pharma-4-0",
      "title": "ISPE Pharma 4.0 programme outputs",
      "short_title": "ISPE Pharma 4.0",
      "authority": "International Society for Pharmaceutical Engineering",
      "jurisdiction": "International",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": null,
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://ispe.org/initiatives/pharma-4.0",
      "secondary_urls": [],
      "topics": [
        "digitalisation",
        "manufacturing"
      ],
      "summary": "ISPE programme publishing guidance and outputs on digitalisation in regulated manufacturing.",
      "watch_cadence": "quarterly",
      "url": "https://gxplex.com/instrument/ispe-pharma-4-0"
    },
    {
      "id": "mhra-ai-airlock",
      "title": "MHRA AI Airlock regulatory sandbox",
      "short_title": "MHRA AI Airlock",
      "authority": "Medicines and Healthcare products Regulatory Agency",
      "jurisdiction": "UK",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": null,
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://www.gov.uk/government/collections/ai-airlock-the-regulatory-sandbox-for-airmd",
      "secondary_urls": [],
      "topics": [
        "artificial intelligence",
        "sandbox"
      ],
      "summary": "MHRA regulatory sandbox for artificial-intelligence-enabled medical devices.",
      "watch_cadence": "monthly",
      "url": "https://gxplex.com/instrument/mhra-ai-airlock"
    },
    {
      "id": "mhra-ai",
      "title": "MHRA publications on AI and software as a medical device",
      "short_title": "MHRA AI",
      "authority": "Medicines and Healthcare products Regulatory Agency",
      "jurisdiction": "UK",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": null,
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://www.gov.uk/government/collections/software-and-artificial-intelligence-ai-as-a-medical-device",
      "secondary_urls": [],
      "topics": [],
      "summary": "MHRA publications addressing software and artificial intelligence as a medical device.",
      "watch_cadence": "monthly",
      "url": "https://gxplex.com/instrument/mhra-ai"
    },
    {
      "id": "nist-agent-standards",
      "title": "NIST standards initiative on autonomous AI agents",
      "short_title": "NIST agent standards",
      "authority": "US National Institute of Standards and Technology",
      "jurisdiction": "US",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": null,
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://www.nist.gov/artificial-intelligence",
      "secondary_urls": [],
      "topics": [
        "autonomous agents",
        "standardisation"
      ],
      "summary": "NIST programme of work addressing standards for autonomous artificial-intelligence agents.",
      "watch_cadence": "monthly",
      "url": "https://gxplex.com/instrument/nist-agent-standards"
    },
    {
      "id": "nist-ai-rmf-playbook",
      "title": "NIST AI RMF Playbook and crosswalks",
      "short_title": "NIST AI RMF Playbook",
      "authority": "US National Institute of Standards and Technology",
      "jurisdiction": "US",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": null,
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://airc.nist.gov/AI_RMF_Knowledge_Base/Playbook",
      "secondary_urls": [],
      "topics": [
        "risk management",
        "crosswalk"
      ],
      "summary": "Companion resources to the NIST AI Risk Management Framework, including the playbook and crosswalks to other frameworks.",
      "watch_cadence": "quarterly",
      "url": "https://gxplex.com/instrument/nist-ai-rmf-playbook"
    },
    {
      "id": "nist-ai-rmf",
      "title": "NIST AI Risk Management Framework 1.0",
      "short_title": "NIST AI RMF",
      "authority": "US National Institute of Standards and Technology",
      "jurisdiction": "International",
      "status": "draft",
      "status_qualifier": "under consultation",
      "status_as_of": "2023-01-26",
      "last_verified": "2026-07-28",
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://www.nist.gov/itl/ai-risk-management-framework",
      "secondary_urls": [],
      "topics": [
        "risk management",
        "artificial intelligence"
      ],
      "summary": "Voluntary framework describing functions for managing risks associated with artificial intelligence systems.",
      "watch_cadence": "quarterly",
      "url": "https://gxplex.com/instrument/nist-ai-rmf"
    },
    {
      "id": "nmpa-ai",
      "title": "NMPA positions on artificial intelligence in regulated products",
      "short_title": "NMPA",
      "authority": "National Medical Products Administration",
      "jurisdiction": "Other",
      "status": "final",
      "status_qualifier": null,
      "status_as_of": null,
      "last_verified": "2026-07-28",
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://english.nmpa.gov.cn/",
      "secondary_urls": [],
      "topics": [
        "artificial intelligence"
      ],
      "summary": "Chinese medical products regulator publications addressing artificial intelligence in regulated products.",
      "watch_cadence": "quarterly",
      "url": "https://gxplex.com/instrument/nmpa-ai"
    },
    {
      "id": "pic-s",
      "title": "PIC/S Guide to Good Manufacturing Practice",
      "short_title": "PIC/S GMP Guide",
      "authority": "Pharmaceutical Inspection Co-operation Scheme",
      "jurisdiction": "International",
      "status": "final",
      "status_qualifier": null,
      "status_as_of": "2011-06-02",
      "last_verified": "2026-07-28",
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://picscheme.org/en/publications",
      "secondary_urls": [],
      "topics": [
        "GMP",
        "inspection"
      ],
      "summary": "GMP guide maintained by PIC/S and applied by participating inspectorates, including annexes on computerised systems and data integrity.",
      "watch_cadence": "quarterly",
      "url": "https://gxplex.com/instrument/pic-s"
    },
    {
      "id": "pics-pi041",
      "title": "PIC/S PI 041 — Good Practices for Data Management and Integrity",
      "short_title": "PIC/S PI 041",
      "authority": "Pharmaceutical Inspection Co-operation Scheme",
      "jurisdiction": "International",
      "status": "final",
      "status_qualifier": null,
      "status_as_of": "2011-06-02",
      "last_verified": "2026-07-28",
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://picscheme.org/en/publications",
      "secondary_urls": [],
      "topics": [
        "data integrity",
        "inspection"
      ],
      "summary": "PIC/S document addressing good practices for data management and integrity in regulated environments.",
      "watch_cadence": "quarterly",
      "url": "https://gxplex.com/instrument/pics-pi041"
    },
    {
      "id": "pmda-ai",
      "title": "PMDA publications on AI in medical products",
      "short_title": "PMDA AI",
      "authority": "Pharmaceuticals and Medical Devices Agency",
      "jurisdiction": "Other",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": "2026-07-17",
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://www.pmda.go.jp/english/",
      "secondary_urls": [],
      "topics": [],
      "summary": "PMDA publications addressing artificial intelligence in medical products.",
      "watch_cadence": "quarterly",
      "url": "https://gxplex.com/instrument/pmda-ai"
    },
    {
      "id": "pren-18229-1",
      "title": "prEN 18229-1 — Trustworthiness framework for AI (Part 1)",
      "short_title": "prEN 18229-1",
      "authority": "CEN/CENELEC JTC 21",
      "jurisdiction": "EU",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": "2021-06-01",
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/",
      "secondary_urls": [],
      "topics": [
        "standardisation",
        "artificial intelligence"
      ],
      "summary": "Draft European standard developed under CEN/CENELEC JTC 21 in support of the EU AI Act.",
      "watch_cadence": "monthly",
      "url": "https://gxplex.com/instrument/pren-18229-1"
    },
    {
      "id": "pren-18229-2",
      "title": "prEN 18229-2 — Trustworthiness framework for AI (Part 2)",
      "short_title": "prEN 18229-2",
      "authority": "CEN/CENELEC JTC 21",
      "jurisdiction": "EU",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": "2021-06-01",
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/",
      "secondary_urls": [],
      "topics": [
        "standardisation",
        "artificial intelligence"
      ],
      "summary": "Draft European standard developed under CEN/CENELEC JTC 21 in support of the EU AI Act.",
      "watch_cadence": "monthly",
      "url": "https://gxplex.com/instrument/pren-18229-2"
    },
    {
      "id": "pren-18281",
      "title": "prEN 18281 — AI quality management",
      "short_title": "prEN 18281",
      "authority": "CEN/CENELEC JTC 21",
      "jurisdiction": "EU",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": "2021-06-01",
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/",
      "secondary_urls": [],
      "topics": [
        "standardisation",
        "quality management",
        "artificial intelligence"
      ],
      "summary": "Draft European standard developed under CEN/CENELEC JTC 21 in support of the EU AI Act.",
      "watch_cadence": "monthly",
      "url": "https://gxplex.com/instrument/pren-18281"
    },
    {
      "id": "pren-18282",
      "title": "prEN 18282 — AI conformity assessment",
      "short_title": "prEN 18282",
      "authority": "CEN/CENELEC JTC 21",
      "jurisdiction": "EU",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": "2021-06-01",
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/",
      "secondary_urls": [],
      "topics": [
        "standardisation",
        "conformity assessment",
        "artificial intelligence"
      ],
      "summary": "Draft European standard developed under CEN/CENELEC JTC 21 in support of the EU AI Act.",
      "watch_cadence": "monthly",
      "url": "https://gxplex.com/instrument/pren-18282"
    },
    {
      "id": "swissmedic-ai",
      "title": "Swissmedic publications on medical device software",
      "short_title": "Swissmedic",
      "authority": "Swissmedic",
      "jurisdiction": "Other",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": null,
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://www.swissmedic.ch/swissmedic/en/home/medical-devices.html",
      "secondary_urls": [],
      "topics": [],
      "summary": "Swissmedic publications addressing medical device software.",
      "watch_cadence": "quarterly",
      "url": "https://gxplex.com/instrument/swissmedic-ai"
    },
    {
      "id": "tga-samd",
      "title": "TGA regulation of software as a medical device",
      "short_title": "TGA SaMD",
      "authority": "Therapeutic Goods Administration",
      "jurisdiction": "Other",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": null,
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://www.tga.gov.au/products/medical-devices/software-based-medical-devices",
      "secondary_urls": [],
      "topics": [],
      "summary": "TGA material addressing the regulation of software-based medical devices.",
      "watch_cadence": "quarterly",
      "url": "https://gxplex.com/instrument/tga-samd"
    },
    {
      "id": "unece-wp29",
      "title": "UNECE WP.29 regulations on automated driving systems",
      "short_title": "UNECE WP.29",
      "authority": "United Nations Economic Commission for Europe",
      "jurisdiction": "International",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": null,
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://unece.org/transport/vehicle-regulations",
      "secondary_urls": [],
      "topics": [],
      "summary": "UNECE regulations addressing automated and autonomous vehicle systems.",
      "watch_cadence": "quarterly",
      "url": "https://gxplex.com/instrument/unece-wp29"
    },
    {
      "id": "us-21-cfr-part-11",
      "title": "21 CFR Part 11 — Electronic Records; Electronic Signatures",
      "short_title": "21 CFR Part 11",
      "authority": "US Food and Drug Administration",
      "jurisdiction": "US",
      "status": "final",
      "status_qualifier": null,
      "status_as_of": "1997-08-20",
      "last_verified": "2026-07-28",
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11",
      "secondary_urls": [],
      "topics": [
        "electronic records",
        "electronic signatures"
      ],
      "summary": "US regulation setting criteria under which electronic records and electronic signatures are considered trustworthy and reliable.",
      "watch_cadence": "quarterly",
      "url": "https://gxplex.com/instrument/us-21-cfr-part-11"
    },
    {
      "id": "us-fsma",
      "title": "FDA Food Safety Modernization Act rules and guidance",
      "short_title": "FSMA",
      "authority": "US Food and Drug Administration",
      "jurisdiction": "US",
      "status": "final",
      "status_qualifier": null,
      "status_as_of": null,
      "last_verified": "2026-07-28",
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/food-safety-modernization-act-fsma",
      "secondary_urls": [],
      "topics": [
        "food safety",
        "records"
      ],
      "summary": "FDA rules and guidance implementing the Food Safety Modernization Act, including record-keeping and traceability requirements.",
      "watch_cadence": "quarterly",
      "url": "https://gxplex.com/instrument/us-fsma"
    },
    {
      "id": "who-ai-health",
      "title": "WHO guidance on artificial intelligence for health",
      "short_title": "WHO AI health",
      "authority": "World Health Organization",
      "jurisdiction": "International",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": "2021-06-28",
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://www.who.int/publications/i/item/9789240029200",
      "secondary_urls": [],
      "topics": [
        "artificial intelligence",
        "health"
      ],
      "summary": "WHO guidance addressing the ethics and governance of artificial intelligence for health.",
      "watch_cadence": "quarterly",
      "url": "https://gxplex.com/instrument/who-ai-health"
    },
    {
      "id": "who-computerised-systems",
      "title": "WHO guideline on computerised systems and data integrity",
      "short_title": "WHO computerised systems",
      "authority": "World Health Organization",
      "jurisdiction": "International",
      "status": "unknown",
      "status_qualifier": null,
      "status_as_of": null,
      "last_verified": null,
      "last_changed": null,
      "effective_date": null,
      "source_url": "https://www.who.int/teams/health-product-policy-and-standards/standards-and-specifications/norms-and-standards-for-pharmaceuticals/guidelines",
      "secondary_urls": [],
      "topics": [
        "computerised systems",
        "data integrity"
      ],
      "summary": "WHO technical guidance addressing computerised systems and data integrity in pharmaceutical manufacture.",
      "watch_cadence": "quarterly",
      "url": "https://gxplex.com/instrument/who-computerised-systems"
    }
  ]
}