Standing register · snapshot
Global regulatory operations
Regulatory movement that is not enforcement and should never be filed as if it were: committee meetings, designations, implementation material, convergence pilots and instruments taking effect. Each row states its action type and its legal effect — a meeting is not a recommendation, a designation is not a healthcare rule, a program is not an entitlement, and a foreign instrument binds only when its own publication record says so.
| Date | Where | Action | State | Legal effect & instrument |
|---|---|---|---|---|
| Global WHO | First meeting, States Parties Committee on IHR implementation GOVERNANCE MILESTONE · Preparedness / outbreak governance | FIRST MEETING IN PROGRESS | None new — implementation architecture for rules already binding International Health Regulations (2005, as amended) | |
| Global WHO | Process opened for a ten-year Global Action Plan on Rare Diseases POLICY PROCESS · Rare disease | PROCESS — NOT A FINAL PLAN | None — discussion paper Q4 2026, draft early 2027, EB 2028, WHA May 2028 WHA pathway | |
| European Union EMA — PRAC | Pharmacovigilance committee meeting, 31 Aug – 3 Sep; agenda published COMMITTEE MEETING · Pharmacovigilance | MEETING IN PROGRESS — OUTCOMES PENDING | None until recommendations; committee recommendation ≠ EMA/Commission final action PRAC agenda | |
| European Union European Commission | ChatGPT designated a Very Large Online Search Engine under the DSA (with Reddit, Roblox as VLOPs) DESIGNATION · Patient-facing general AI / health information | DESIGNATED — ADDITIONAL OBLIGATIONS DUE END NOVEMBER 2026 | Systemic-risk assessment and mitigation duties attach on the compliance date Digital Services Act | |
| International FDA / ICMRA (EMA lead; TGA, Health Canada, PMDA, Swissmedic) | Collaborative assessment completed: recombinant endotoxin testing reducing horseshoe-crab reliance REGULATORY CONVERGENCE · Pharmaceutical quality | ASSESSMENT COMPLETED — ALIGNED DECISIONS | National decisions issued under each authority's own law ICMRA collaborative-assessment pilot | |
| United Kingdom NHS England | ~100-pharmacy pilot: rapid cholesterol checks, BP assessment, pharmacist-prescriber consultation (ages 40–84, to spring 2027) PROGRAM PILOT · Cardiovascular prevention / scope of practice | ANNOUNCED — PILOT FROM AUTUMN | None — service model NHS England announcement | |
| Australia TGA | Healthcare implementation material expanded for Unique Device Identification (AusUDID; My Health Record integration) IMPLEMENTATION GUIDANCE · Device traceability | PUBLISHED | Supports existing UDI framework duties on manufacturers TGA UDI framework | |
| Australia TGA | Guidance updated: seasonal-influenza rapid antigen tests; Class 3 self-test audit selection; combination flu/SARS-CoV-2/RSV tests GUIDANCE UPDATE · IVD / self-testing | PUBLISHED | Guidance — application requirements, incl. reliance on comparable overseas approvals TGA IVD guidance | |
| Japan PMDA | New consultation schedule, Office of Software as a Medical Device REGULATORY OPERATIONS · SaMD / digital health | OPERATIONS UPDATE — NOT A NEW RULE | None PMDA consultation calendar | |
| Mexico Presidency / Secretaría de Salud | National youth mental-health strategy launched: El ABC de las emociones (ages 14–18, school-centred) PROGRAM LAUNCH · Youth mental health | NATIONAL PROGRAM — NOT A STATUTORY ENTITLEMENT | None — program, not legislation Presidency announcement | |
| Russia Roszdravnadzor | Order 662 (22 July 2026) effective: inspection checklists for medical-device circulation oversight FINAL RULE · Device oversight | EFFECTIVE | Binding checklists across testing, clinical use, manufacture, service, transport, storage, sale Order 662; MinJust reg. 87896; publication 0001202608200005 |
Enforcement stays on the enforcement ledger; U.S. rulemaking dates sit on the decision calendar; predictions live at Forecasts.