World Health Organization
WHO · Global (United Nations specialised agency) · europe
Global health authority — Hirudo medicinalis listed in the WHO Monographs on Selected Medicinal Plants (informational) and embedded in the Traditional Medicine Strategy 2014–2023 and 2025–2034 successor.
Regulatory Profile
- Agency type
- supranational
- Region
- europe
- Country
- Global (United Nations specialised agency)
- Leech status
- traditional medicine
- Last ASH review
- 2026-05-25
- Website
- https://www.who.int
Relevant Regulation Codes
- WHO Traditional Medicine Strategy 2014–2023
- WHO Traditional Medicine Strategy 2025–2034 (in development)
- WHO Benchmarks for Training in Traditional/Complementary and Integrative Medicine
- ICD-11 Chapter 26 — Supplementary Chapter on Traditional Medicine Conditions (Module 1)
Prescriber Requirements
- WHO does not licence prescribers; sets normative guidance for Member States
- WHO Benchmarks publications (2022 onwards) include training expectations for traditional medicine modalities — hirudotherapy referenced in regional supplements (SEARO, EMRO)
Supply Chain & GMP
WHO does not regulate manufacturing; publishes GMP guidance via the Expert Committee on Specifications for Pharmaceutical Preparations.
Import/Export Rules
WHO does not regulate imports; works with World Customs Organization on global supply-chain norms.
Reimbursement Context
WHO does not set reimbursement; Universal Health Coverage agenda urges Member States to integrate evidence-based traditional medicines including hirudotherapy where appropriate.
Key Regulatory Documents
ASH Editorial Notes
The WHO Global Centre for Traditional Medicine (GCTM) in Jamnagar, India (operational since 2022) is a major reference point; hirudotherapy positioned within Traditional Medicine Strategy and the WHO Benchmarks series, but no monograph specific to Hirudo medicinalis as a clinical intervention has been issued.
Related Jurisdictions
EMA — European Union
Centralised EU authority for medicinal products — leeches sit on the border between MDR-regulated device and HMPC traditional herbal medicine framework.
European Commission — European Union
EU executive body responsible for the Medical Device Regulation (MDR) — the legal instrument that frames how Member States CE-mark leech products.
MHRA — United Kingdom
Post-Brexit UK regulator — accepts EU CE marks during transition, with UKCA marking now phased in for Great Britain (Northern Ireland follows EU MDR via Windsor Framework).
BfArM — Germany
Germany classifies medicinal leeches as a finished medicinal product (Fertigarzneimittel) — uniquely strict among EU Member States and requires marketing authorisation via BfArM.