{ "schema_version": 1, "collection": "instruments", "generated_at": "2026-08-03", "source": "https://gxplex.com", "notice": "Reports the published status of regulatory documents. No advice or interpretation.", "source_terms": "This site compiles publicly available regulatory information. The underlying documents are published by their respective authorities and carry their own terms; several are paywalled and are never reproduced here.", "count": 86, "items": [ { "id": "anvisa-ai", "title": "ANVISA positions on computerised systems and artificial intelligence", "short_title": "ANVISA", "authority": "Agência Nacional de Vigilância Sanitária", "jurisdiction": "Brazil", "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", "licence_class": "open", "text_retained": false, "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": "final", "status_qualifier": null, "status_as_of": "2023-02-23", "last_verified": "2026-07-29", "last_changed": null, "effective_date": null, "source_url": "https://www.astm.org/e2363-23.html", "secondary_urls": [], "topics": [ "terminology" ], "summary": "Standard terminology relating to process analytical technology in the pharmaceutical industry.", "watch_cadence": "quarterly", "licence_class": "restricted", "text_retained": true, "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": "final", "status_qualifier": null, "status_as_of": "2025-04-01", "last_verified": "2026-07-29", "last_changed": null, "effective_date": null, "source_url": "https://www.astm.org/e2500-25.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", "licence_class": "restricted", "text_retained": true, "url": "https://gxplex.com/instrument/astm-e2500" }, { "id": "astm-e2537", "title": "ASTM E2537 — Continuous quality verification", "short_title": "ASTM E2537", "authority": "ASTM International", "jurisdiction": "International", "status": "final", "status_qualifier": null, "status_as_of": "2024-10-30", "last_verified": "2026-07-31", "last_changed": null, "effective_date": null, "source_url": "https://www.astm.org/e2537-16.html", "secondary_urls": [], "topics": [ "continuous quality verification", "process data", "manufacturing" ], "summary": "Standard guide for the application of continuous quality verification to pharmaceutical and biopharmaceutical manufacturing.", "watch_cadence": "monthly", "licence_class": "restricted", "text_retained": false, "url": "https://gxplex.com/instrument/astm-e2537" }, { "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", "licence_class": "open", "text_retained": false, "url": "https://gxplex.com/instrument/cen-jtc21-programme" }, { "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", "licence_class": "open", "text_retained": true, "url": "https://gxplex.com/instrument/ema-ai-reflection" }, { "id": "ema-annex11-concept-paper", "title": "EMA concept paper on the revision of Annex 11", "short_title": "Annex 11 concept paper", "authority": "European Medicines Agency", "jurisdiction": "EU", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/concept-paper-revision-annex-11-guidelines-good-manufacturing-practice-medicinal-products-computerised-systems_en.pdf", "secondary_urls": [], "topics": [ "computerised systems", "GMP", "consultation" ], "summary": "The concept paper that initiated the current revision of EU GMP Annex 11, setting out the scope of the intended changes.", "watch_cadence": "weekly", "licence_class": "open", "text_retained": true, "url": "https://gxplex.com/instrument/ema-annex11-concept-paper" }, { "id": "ema-ct-computerised-systems", "title": "EMA guideline on computerised systems and electronic data in clinical trials", "short_title": "EMA CT computerised systems", "authority": "European Medicines Agency", "jurisdiction": "EU", "status": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-08-01", "last_changed": null, "effective_date": null, "source_url": "https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf", "secondary_urls": [], "topics": [ "computerised systems", "clinical trials", "data integrity", "GCP" ], "summary": "Guideline addressing computerised systems and electronic data in clinical trials, covering validation, data integrity, security and cloud-based solutions.", "watch_cadence": "monthly", "licence_class": "open", "text_retained": true, "url": "https://gxplex.com/instrument/ema-ct-computerised-systems" }, { "id": "ema-pics-annex15-concept", "title": "EMA and PIC/S concept paper on the revision of GMP Annex 15", "short_title": "Annex 15 revision concept paper", "authority": "European Medicines Agency and Pharmaceutical Inspection Co-operation Scheme", "jurisdiction": "International", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guidelines-good-manufacturing-practice-medicinal-products-annex-15-qualification-validation-corrigendum_en.pdf", "secondary_urls": [], "topics": [ "qualification", "validation", "GMP", "consultation" ], "summary": "Joint concept paper published in January 2026 setting out the intended revision of GMP Annex 15, including extension of its scope to active substance manufacturers.", "watch_cadence": "weekly", "licence_class": "open", "text_retained": true, "url": "https://gxplex.com/instrument/ema-pics-annex15-concept" }, { "id": "ema-pics-data-integrity-concept", "title": "EMA and PIC/S concept paper on the revision of GMP guidance on data management and integrity", "short_title": "DI revision concept paper", "authority": "European Medicines Agency and Pharmaceutical Inspection Co-operation Scheme", "jurisdiction": "International", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/compliance-research-and-development/good-manufacturing-practice", "secondary_urls": [], "topics": [ "data integrity", "data management", "GMP", "consultation" ], "summary": "Joint concept paper opened for consultation in February 2026 setting out the intended revision of GMP guidance on data management and integrity, the framework currently carried by PIC/S PI 041.", "watch_cadence": "weekly", "licence_class": "open", "text_retained": false, "url": "https://gxplex.com/instrument/ema-pics-data-integrity-concept" }, { "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/annual-reports-work-programmes", "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", "licence_class": "open", "text_retained": false, "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", "licence_class": "open", "text_retained": true, "url": "https://gxplex.com/instrument/eu-ai-act" }, { "id": "eu-cyber-resilience-act", "title": "Regulation (EU) 2024/2847 — Cyber Resilience Act", "short_title": "EU Cyber Resilience Act", "authority": "European Parliament and Council", "jurisdiction": "EU", "status": "in-force", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-07-31", "last_changed": null, "effective_date": null, "source_url": "https://eur-lex.europa.eu/eli/reg/2024/2847/oj", "secondary_urls": [], "topics": [ "cybersecurity", "products with digital elements", "vulnerability reporting" ], "summary": "Regulation on horizontal cybersecurity requirements for products with digital elements, including manufacturer obligations on vulnerability handling and incident reporting.", "watch_cadence": "weekly", "licence_class": "open", "text_retained": true, "url": "https://gxplex.com/instrument/eu-cyber-resilience-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": "in-force", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-07-30", "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", "licence_class": "open", "text_retained": true, "url": "https://gxplex.com/instrument/eu-gmp-annex-11" }, { "id": "eu-gmp-annex-15", "title": "EudraLex Volume 4, Annex 15 — Qualification and Validation", "short_title": "EU GMP Annex 15", "authority": "European Commission", "jurisdiction": "EU", "status": "in-force", "status_qualifier": null, "status_as_of": "2015-03-30", "last_verified": "2026-07-31", "last_changed": null, "effective_date": null, "source_url": "https://health.ec.europa.eu/document/download/7c6c5b3c-4902-46ea-b7ab-7608682fb68d_en?filename=2015-10_annex15.pdf", "secondary_urls": [], "topics": [ "qualification", "validation", "GMP", "computerised systems" ], "summary": "Annex to the EU GMP guide setting out principles of qualification and validation applicable to facilities, equipment, utilities and processes, including computerised systems.", "watch_cadence": "weekly", "licence_class": "open", "text_retained": true, "url": "https://gxplex.com/instrument/eu-gmp-annex-15" }, { "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": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://health.ec.europa.eu/document/download/5f38a92d-bb8e-4264-8898-ea076e926db6_en?filename=mp_vol4_chap4_annex22_consultation_guideline_en.pdf", "secondary_urls": [], "topics": [ "artificial intelligence", "GMP" ], "summary": "Proposed GMP annex addressing the use of artificial intelligence in regulated manufacturing operations.", "watch_cadence": "weekly", "licence_class": "open", "text_retained": true, "url": "https://gxplex.com/instrument/eu-gmp-annex-22" }, { "id": "eu-gmp-chapter-4", "title": "EudraLex Volume 4, Chapter 4 — Documentation", "short_title": "EU GMP Chapter 4", "authority": "European Commission", "jurisdiction": "EU", "status": "in-force", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-07-31", "last_changed": null, "effective_date": null, "source_url": "https://health.ec.europa.eu/document/download/104b3eb8-81a7-4858-9419-cb06562adb66_en?filename=chapter4_01-2011_en.pdf", "secondary_urls": [], "topics": [ "documentation", "records", "GMP", "electronic records" ], "summary": "Chapter of the EU GMP guide governing documentation and records, including provisions bearing on records held in computerised systems.", "watch_cadence": "monthly", "licence_class": "open", "text_retained": true, "url": "https://gxplex.com/instrument/eu-gmp-chapter-4" }, { "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", "licence_class": "open", "text_retained": true, "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", "licence_class": "open", "text_retained": true, "url": "https://gxplex.com/instrument/eu-mdr" }, { "id": "eu-nis2", "title": "Directive (EU) 2022/2555 — NIS2", "short_title": "EU NIS2 Directive", "authority": "European Parliament and Council", "jurisdiction": "EU", "status": "in-force", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-07-31", "last_changed": null, "effective_date": null, "source_url": "https://eur-lex.europa.eu/eli/dir/2022/2555/oj", "secondary_urls": [], "topics": [ "cybersecurity", "incident reporting", "supply chain", "essential entities" ], "summary": "Directive on measures for a high common level of cybersecurity across the Union. Classifies manufacturers of basic pharmaceutical products, medical devices and in vitro diagnostics among essential entities.", "watch_cadence": "weekly", "licence_class": "open", "text_retained": true, "url": "https://gxplex.com/instrument/eu-nis2" }, { "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": "draft", "status_qualifier": "recorded as draft against the primary source", "status_as_of": null, "last_verified": "2026-07-30", "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", "licence_class": "open", "text_retained": true, "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", "licence_class": "open", "text_retained": true, "url": "https://gxplex.com/instrument/fda-aiml-device-list" }, { "id": "fda-cdrh-aiml", "title": "Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations", "short_title": "FDA CDRH AI/ML", "authority": "US Food and Drug Administration", "jurisdiction": "US", "status": "draft", "status_qualifier": "recorded as draft against the primary source", "status_as_of": null, "last_verified": "2026-07-30", "last_changed": null, "effective_date": null, "source_url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/artificial-intelligence-enabled-device-software-functions-lifecycle-management-and-marketing", "secondary_urls": [], "topics": [], "summary": "FDA guidance addressing artificial-intelligence-enabled device software functions and predetermined change control plans.", "watch_cadence": "monthly", "licence_class": "open", "text_retained": true, "url": "https://gxplex.com/instrument/fda-cdrh-aiml" }, { "id": "fda-csa", "title": "Computer Software Assurance for Production and Quality Management System Software", "short_title": "FDA CSA", "authority": "US Food and Drug Administration", "jurisdiction": "US", "status": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-07-30", "last_changed": null, "effective_date": null, "source_url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/computer-software-assurance-production-and-quality-management-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", "licence_class": "open", "text_retained": true, "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", "licence_class": "open", "text_retained": true, "url": "https://gxplex.com/instrument/fda-data-integrity" }, { "id": "fda-device-cybersecurity", "title": "Cybersecurity in Medical Devices — Quality System Considerations and Content of Premarket Submissions", "short_title": "FDA device cybersecurity", "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/cybersecurity-medical-devices-quality-system-considerations-and-content-premarket-submissions", "secondary_urls": [], "topics": [ "cybersecurity", "medical devices", "premarket submissions" ], "summary": "FDA guidance on cybersecurity expectations for medical devices, covering quality system considerations and the content of premarket submissions.", "watch_cadence": "monthly", "licence_class": "open", "text_retained": true, "url": "https://gxplex.com/instrument/fda-device-cybersecurity" }, { "id": "fda-ema-good-ai-practice", "title": "Guiding Principles of Good AI Practice in Drug Development", "short_title": "FDA/EMA AI principles", "authority": "US Food and Drug Administration and European Medicines 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.ema.europa.eu/en/documents/other/guiding-principles-good-ai-practice-drug-development_en.pdf", "secondary_urls": [ "https://www.fda.gov/media/189581/download" ], "topics": [ "artificial intelligence", "drug development", "manufacturing", "international harmonisation" ], "summary": "Ten principles jointly issued by the FDA and EMA addressing the use of artificial intelligence across the product lifecycle, including manufacturing.", "watch_cadence": "weekly", "licence_class": "open", "text_retained": true, "url": "https://gxplex.com/instrument/fda-ema-good-ai-practice" }, { "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", "licence_class": "open", "text_retained": false, "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/cder-guidance-agenda", "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", "licence_class": "open", "text_retained": true, "url": "https://gxplex.com/instrument/fda-guidance-agenda" }, { "id": "fda-part-11-scope", "title": "Part 11, Electronic Records; Electronic Signatures — Scope and Application", "short_title": "FDA Part 11 scope", "authority": "US Food and Drug Administration", "jurisdiction": "US", "status": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-07-31", "last_changed": null, "effective_date": null, "source_url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application", "secondary_urls": [], "topics": [ "electronic records", "electronic signatures", "enforcement discretion" ], "summary": "FDA guidance describing how the agency intends to interpret and enforce 21 CFR Part 11. A separate document from the rule text.", "watch_cadence": "monthly", "licence_class": "open", "text_retained": true, "url": "https://gxplex.com/instrument/fda-part-11-scope" }, { "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", "licence_class": "open", "text_retained": true, "url": "https://gxplex.com/instrument/fda-pccp" }, { "id": "fda-process-analytical-framework", "title": "PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance", "short_title": "FDA process analytical framework", "authority": "US Food and Drug Administration", "jurisdiction": "US", "status": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-07-31", "last_changed": null, "effective_date": null, "source_url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pat-framework-innovative-pharmaceutical-development-manufacturing-and-quality-assurance", "secondary_urls": [], "topics": [ "process analytical technology", "real-time release", "process data" ], "summary": "FDA guidance describing a framework for process analytical technology, including how process data may support real-time release testing.", "watch_cadence": "monthly", "licence_class": "open", "text_retained": true, "url": "https://gxplex.com/instrument/fda-process-analytical-framework" }, { "id": "fda-software-validation", "title": "General Principles of Software Validation", "short_title": "FDA software validation", "authority": "US Food and Drug Administration", "jurisdiction": "US", "status": "final", "status_qualifier": null, "status_as_of": "1997-06-09", "last_verified": "2026-07-31", "last_changed": null, "effective_date": null, "source_url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-principles-software-validation", "secondary_urls": [], "topics": [ "software validation", "computerised systems", "medical devices" ], "summary": "FDA guidance on validation of software used in medical devices and in the production of regulated products. Predates Computer Software Assurance and remains extant.", "watch_cadence": "monthly", "licence_class": "open", "text_retained": true, "url": "https://gxplex.com/instrument/fda-software-validation" }, { "id": "health-canada-ml", "title": "Health Canada guidance on machine learning medical devices", "short_title": "Health Canada ML", "authority": "Health Canada", "jurisdiction": "Canada", "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", "licence_class": "open", "text_retained": true, "url": "https://gxplex.com/instrument/health-canada-ml" }, { "id": "ich-e6r3", "title": "ICH E6(R3) — Good Clinical Practice", "short_title": "ICH E6(R3)", "authority": "International Council for Harmonisation", "jurisdiction": "International", "status": "final", "status_qualifier": null, "status_as_of": "2022-02-21", "last_verified": "2026-07-29", "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", "licence_class": "open", "text_retained": true, "url": "https://gxplex.com/instrument/ich-e6r3" }, { "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": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-07-29", "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", "licence_class": "open", "text_retained": true, "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": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-07-29", "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", "licence_class": "open", "text_retained": true, "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": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-07-29", "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", "licence_class": "open", "text_retained": true, "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": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-07-30", "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", "licence_class": "open", "text_retained": true, "url": "https://gxplex.com/instrument/ich-q2r2" }, { "id": "ich-q9r1", "title": "ICH Q9(R1) — Quality Risk Management", "short_title": "ICH Q9(R1)", "authority": "International Council for Harmonisation", "jurisdiction": "International", "status": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-07-29", "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", "licence_class": "open", "text_retained": true, "url": "https://gxplex.com/instrument/ich-q9r1" }, { "id": "iec-62304", "title": "IEC 62304 — Medical device software life cycle processes", "short_title": "IEC 62304", "authority": "ISO/IEC", "jurisdiction": "International", "status": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-07-31", "last_changed": null, "effective_date": null, "source_url": "https://www.iso.org/standard/38421.html", "secondary_urls": [], "topics": [ "software lifecycle", "medical devices", "validation" ], "summary": "Standard defining life cycle requirements for medical device software, including software safety classification.", "watch_cadence": "monthly", "licence_class": "restricted", "text_retained": false, "url": "https://gxplex.com/instrument/iec-62304" }, { "id": "iec-62443", "title": "IEC 62443 series — Security for industrial automation and control systems", "short_title": "IEC 62443", "authority": "IEC / ISA", "jurisdiction": "International", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://www.isa.org/standards-and-publications/isa-standards/isa-iec-62443-series-of-standards", "secondary_urls": [], "topics": [ "OT security", "industrial control systems", "secure development" ], "summary": "Standard family addressing security for industrial automation and control systems, including secure development lifecycle requirements and component security requirements.", "watch_cadence": "monthly", "licence_class": "restricted", "text_retained": false, "url": "https://gxplex.com/instrument/iec-62443" }, { "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": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-07-30", "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", "licence_class": "restricted", "text_retained": true, "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", "licence_class": "open", "text_retained": false, "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", "licence_class": "open", "text_retained": true, "url": "https://gxplex.com/instrument/imdrf-samd" }, { "id": "iso-13485", "title": "ISO 13485 — Medical devices, quality management systems", "short_title": "ISO 13485", "authority": "ISO/IEC", "jurisdiction": "International", "status": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-07-31", "last_changed": null, "effective_date": null, "source_url": "https://www.iso.org/standard/59752.html", "secondary_urls": [], "topics": [ "quality management", "medical devices" ], "summary": "Standard specifying quality management system requirements for organisations involved in the medical device life cycle.", "watch_cadence": "monthly", "licence_class": "restricted", "text_retained": false, "url": "https://gxplex.com/instrument/iso-13485" }, { "id": "iso-14971", "title": "ISO 14971 — Application of risk management to medical devices", "short_title": "ISO 14971", "authority": "ISO/IEC", "jurisdiction": "International", "status": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-07-31", "last_changed": null, "effective_date": null, "source_url": "https://www.iso.org/standard/72704.html", "secondary_urls": [], "topics": [ "risk management", "medical devices" ], "summary": "Standard specifying a process for managing risks associated with medical devices, including software.", "watch_cadence": "monthly", "licence_class": "restricted", "text_retained": false, "url": "https://gxplex.com/instrument/iso-14971" }, { "id": "iso-iec-22989", "title": "ISO/IEC 22989 — Artificial intelligence concepts and terminology", "short_title": "ISO/IEC 22989", "authority": "ISO/IEC", "jurisdiction": "International", "status": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-07-29", "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", "licence_class": "restricted", "text_retained": false, "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": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-07-29", "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", "licence_class": "restricted", "text_retained": false, "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": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-07-29", "last_changed": null, "effective_date": null, "source_url": "https://www.iso.org/committee/6794475/x/catalogue/", "secondary_urls": [], "topics": [ "trustworthiness", "artificial intelligence" ], "summary": "Technical report giving an overview of trustworthiness in artificial intelligence systems.", "watch_cadence": "quarterly", "licence_class": "restricted", "text_retained": false, "url": "https://gxplex.com/instrument/iso-iec-24028" }, { "id": "iso-iec-27001", "title": "ISO/IEC 27001:2022 — Information security management systems", "short_title": "ISO/IEC 27001", "authority": "ISO/IEC", "jurisdiction": "International", "status": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-08-01", "last_changed": null, "effective_date": null, "source_url": "https://www.iso.org/standard/27001", "secondary_urls": [], "topics": [ "information security", "management system", "cybersecurity" ], "summary": "Standard specifying requirements for an information security management system. Named in the draft revision of EU GMP Annex 11 as an aligned framework.", "watch_cadence": "monthly", "licence_class": "restricted", "text_retained": false, "url": "https://gxplex.com/instrument/iso-iec-27001" }, { "id": "iso-iec-27002", "title": "ISO/IEC 27002:2022 — Information security controls", "short_title": "ISO/IEC 27002", "authority": "ISO/IEC", "jurisdiction": "International", "status": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-08-01", "last_changed": null, "effective_date": null, "source_url": "https://www.iso.org/standard/75652.html", "secondary_urls": [], "topics": [ "information security", "controls", "cybersecurity" ], "summary": "Companion standard to ISO/IEC 27001 setting out information security controls and implementation guidance.", "watch_cadence": "monthly", "licence_class": "restricted", "text_retained": false, "url": "https://gxplex.com/instrument/iso-iec-27002" }, { "id": "iso-iec-27017", "title": "ISO/IEC 27017 — Information security controls for cloud services", "short_title": "ISO/IEC 27017", "authority": "ISO/IEC", "jurisdiction": "International", "status": "withdrawn", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-08-01", "last_changed": null, "effective_date": null, "source_url": "https://www.iso.org/standard/43757.html", "secondary_urls": [], "topics": [ "cloud security", "information security", "controls" ], "summary": "Standard setting out information security controls and implementation guidance applicable to cloud services, used alongside ISO/IEC 27001 and 27002 in supplier assessment.", "watch_cadence": "weekly", "licence_class": "restricted", "text_retained": false, "url": "https://gxplex.com/instrument/iso-iec-27017" }, { "id": "iso-iec-27018", "title": "ISO/IEC 27018 — Protection of personally identifiable information in public clouds", "short_title": "ISO/IEC 27018", "authority": "ISO/IEC", "jurisdiction": "International", "status": "withdrawn", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-08-01", "last_changed": null, "effective_date": null, "source_url": "https://www.iso.org/standard/76559.html", "secondary_urls": [], "topics": [ "cloud security", "personal data", "controls" ], "summary": "Standard giving a code of practice for protection of personally identifiable information processed in public cloud computing services.", "watch_cadence": "weekly", "licence_class": "restricted", "text_retained": false, "url": "https://gxplex.com/instrument/iso-iec-27018" }, { "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": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-07-29", "last_changed": null, "effective_date": null, "source_url": "https://www.iso.org/committee/6794475/x/catalogue/", "secondary_urls": [], "topics": [ "governance", "artificial intelligence" ], "summary": "Standard addressing the governance implications of organisational use of artificial intelligence.", "watch_cadence": "quarterly", "licence_class": "restricted", "text_retained": false, "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": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-07-29", "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", "licence_class": "restricted", "text_retained": false, "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": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-07-29", "last_changed": null, "effective_date": null, "source_url": "https://www.iso.org/committee/6794475/x/catalogue/", "secondary_urls": [], "topics": [ "impact assessment", "artificial intelligence" ], "summary": "Standard addressing impact assessment for artificial intelligence systems.", "watch_cadence": "quarterly", "licence_class": "restricted", "text_retained": false, "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": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-07-29", "last_changed": null, "effective_date": null, "source_url": "https://www.iso.org/committee/6794475/x/catalogue/", "secondary_urls": [], "topics": [ "data quality", "machine learning" ], "summary": "Multi-part standard series addressing data quality for analytics and machine learning.", "watch_cadence": "quarterly", "licence_class": "restricted", "text_retained": false, "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": "2026-07-31", "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", "licence_class": "open", "text_retained": false, "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", "licence_class": "restricted", "text_retained": false, "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", "licence_class": "restricted", "text_retained": false, "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", "licence_class": "restricted", "text_retained": false, "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": "2024-05-09", "last_verified": "2026-07-31", "last_changed": null, "effective_date": null, "source_url": "https://www.gov.uk/government/collections/ai-airlock-the-regulatory-sandbox-for-aiamd", "secondary_urls": [], "topics": [ "artificial intelligence", "sandbox" ], "summary": "MHRA regulatory sandbox for artificial-intelligence-enabled medical devices.", "watch_cadence": "monthly", "licence_class": "open", "text_retained": false, "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": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-07-30", "last_changed": null, "effective_date": null, "source_url": "https://www.gov.uk/government/publications/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", "licence_class": "open", "text_retained": true, "url": "https://gxplex.com/instrument/mhra-ai" }, { "id": "mhra-data-integrity", "title": "MHRA GxP Data Integrity Guidance and Definitions", "short_title": "MHRA data integrity", "authority": "Medicines and Healthcare products Regulatory Agency", "jurisdiction": "UK", "status": "final", "status_qualifier": null, "status_as_of": "2018-03-09", "last_verified": "2026-07-31", "last_changed": null, "effective_date": null, "source_url": "https://www.gov.uk/government/publications/guidance-on-gxp-data-integrity", "secondary_urls": [], "topics": [ "data integrity", "GxP", "records" ], "summary": "MHRA guidance on data integrity expectations across GxP, with definitions used by inspectors.", "watch_cadence": "weekly", "licence_class": "open", "text_retained": true, "url": "https://gxplex.com/instrument/mhra-data-integrity" }, { "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", "licence_class": "open", "text_retained": false, "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", "licence_class": "open", "text_retained": false, "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": "unknown", "status_qualifier": null, "status_as_of": "2023-01-01", "last_verified": "2026-08-01", "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", "licence_class": "open", "text_retained": true, "url": "https://gxplex.com/instrument/nist-ai-rmf" }, { "id": "nist-csf", "title": "NIST Cybersecurity Framework 2.0", "short_title": "NIST CSF 2.0", "authority": "US National Institute of Standards and Technology", "jurisdiction": "US", "status": "final", "status_qualifier": null, "status_as_of": "2024-02-26", "last_verified": "2026-08-01", "last_changed": null, "effective_date": null, "source_url": "https://csrc.nist.gov/pubs/cswp/29/the-nist-cybersecurity-framework-csf-20/final", "secondary_urls": [ "https://nvlpubs.nist.gov/nistpubs/CSWP/NIST.CSWP.29.pdf" ], "topics": [ "cybersecurity", "risk management", "governance" ], "summary": "NIST framework organising cybersecurity outcomes into functions, categories and subcategories. Referenced alongside NIST SP 800-82 in operational technology security work.", "watch_cadence": "monthly", "licence_class": "open", "text_retained": true, "url": "https://gxplex.com/instrument/nist-csf" }, { "id": "nist-sp-800-82", "title": "NIST SP 800-82 — Guide to Operational Technology Security", "short_title": "NIST SP 800-82", "authority": "US National Institute of Standards and Technology", "jurisdiction": "US", "status": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-08-01", "last_changed": null, "effective_date": null, "source_url": "https://csrc.nist.gov/pubs/sp/800/82/r3/final", "secondary_urls": [], "topics": [ "OT security", "industrial control systems", "cybersecurity" ], "summary": "NIST guidance on securing operational technology, including industrial control systems, referenced in work harmonising OT security practice.", "watch_cadence": "monthly", "licence_class": "open", "text_retained": true, "url": "https://gxplex.com/instrument/nist-sp-800-82" }, { "id": "nmpa-ai", "title": "NMPA positions on artificial intelligence in regulated products", "short_title": "NMPA", "authority": "National Medical Products Administration", "jurisdiction": "China", "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", "licence_class": "open", "text_retained": true, "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": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "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", "licence_class": "restricted", "text_retained": false, "url": "https://gxplex.com/instrument/pic-s" }, { "id": "pics-annex-11", "title": "PIC/S GMP Guide, Annex 11 — Computerised Systems", "short_title": "PIC/S Annex 11", "authority": "Pharmaceutical Inspection Co-operation Scheme", "jurisdiction": "International", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://picscheme.org/en/publications?tri=gmp", "secondary_urls": [], "topics": [ "computerised systems", "GMP", "inspection" ], "summary": "The PIC/S GMP guide annex on computerised systems, published and revised separately from the EU instrument of the same number.", "watch_cadence": "weekly", "licence_class": "open", "text_retained": false, "url": "https://gxplex.com/instrument/pics-annex-11" }, { "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": null, "last_verified": "2026-08-01", "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", "licence_class": "open", "text_retained": false, "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": "Japan", "status": "unknown", "status_qualifier": null, "status_as_of": null, "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", "licence_class": "open", "text_retained": false, "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": 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": [ "standardisation", "artificial intelligence" ], "summary": "Draft European standard developed under CEN/CENELEC JTC 21 in support of the EU AI Act.", "watch_cadence": "monthly", "licence_class": "restricted", "text_retained": false, "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": 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": [ "standardisation", "artificial intelligence" ], "summary": "Draft European standard developed under CEN/CENELEC JTC 21 in support of the EU AI Act.", "watch_cadence": "monthly", "licence_class": "restricted", "text_retained": false, "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": 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": [ "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", "licence_class": "restricted", "text_retained": false, "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": 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": [ "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", "licence_class": "restricted", "text_retained": false, "url": "https://gxplex.com/instrument/pren-18282" }, { "id": "swissmedic-ai", "title": "Swissmedic publications on medical device software", "short_title": "Swissmedic", "authority": "Swissmedic", "jurisdiction": "Switzerland", "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", "licence_class": "open", "text_retained": false, "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": "Australia", "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", "licence_class": "open", "text_retained": false, "url": "https://gxplex.com/instrument/tga-samd" }, { "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": "in-force", "status_qualifier": null, "status_as_of": "1997-08-20", "last_verified": "2026-08-01", "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", "licence_class": "open", "text_retained": true, "url": "https://gxplex.com/instrument/us-21-cfr-part-11" }, { "id": "us-21-cfr-part-211", "title": "21 CFR Part 211 — Current Good Manufacturing Practice for Finished Pharmaceuticals", "short_title": "21 CFR Part 211", "authority": "US Food and Drug Administration", "jurisdiction": "US", "status": "in-force", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-08-01", "last_changed": null, "effective_date": null, "source_url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211", "secondary_urls": [], "topics": [ "CGMP", "records", "automatic equipment", "laboratory records" ], "summary": "The US current good manufacturing practice regulations for finished pharmaceuticals, including provisions on automatic and electronic equipment, record retention and laboratory records.", "watch_cadence": "weekly", "licence_class": "open", "text_retained": true, "url": "https://gxplex.com/instrument/us-21-cfr-part-211" }, { "id": "who-ai-health", "title": "WHO guidance on artificial intelligence for health", "short_title": "WHO AI health", "authority": "World Health Organization", "jurisdiction": "International", "status": "final", "status_qualifier": null, "status_as_of": "2021-06-28", "last_verified": "2026-07-30", "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", "licence_class": "open", "text_retained": true, "url": "https://gxplex.com/instrument/who-ai-health" }, { "id": "who-annex5-data-management", "title": "WHO Annex 5 — Guidance on Good Data and Record Management Practices", "short_title": "WHO data management", "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://iris.who.int/", "secondary_urls": [], "topics": [ "data integrity", "records", "GxP" ], "summary": "WHO guidance on good data and record management practices, published as an annex to a WHO Expert Committee technical report.", "watch_cadence": "monthly", "licence_class": "open", "text_retained": false, "url": "https://gxplex.com/instrument/who-annex5-data-management" }, { "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", "secondary_urls": [], "topics": [ "computerised systems", "data integrity" ], "summary": "WHO technical guidance addressing computerised systems and data integrity in pharmaceutical manufacture.", "watch_cadence": "quarterly", "licence_class": "open", "text_retained": false, "url": "https://gxplex.com/instrument/who-computerised-systems" } ] }