National Medical Products Administration
NMPA · China · asia pacific
China's medical-products regulator — leeches (水蛭 / shui zhi) are codified in the Chinese Pharmacopoeia as Traditional Chinese Medicine (TCM) and regulated as a Chinese herbal medicine.
Regulatory Profile
- Agency type
- national regulator
- Region
- asia pacific
- Country
- China
- Leech status
- traditional medicine
- Last ASH review
- 2026-05-25
- Website
- https://english.nmpa.gov.cn
Relevant Regulation Codes
- Drug Administration Law of the People's Republic of China (revised 2019)
- Chinese Pharmacopoeia, 2020 ed., monograph 水蛭 (shui zhi)
- Regulations on the Administration of Traditional Chinese Medicine, 2017
Prescriber Requirements
- Licensed TCM practitioner (中医师 / zhongyi-shi) or biomedical physician (西医师 / xiyi-shi) with TCM scope
- Hirudotherapy training integrated into TCM curricula at universities such as Beijing UCM and Shanghai UCM
- Application by nurses under standing order in hospital settings
Supply Chain & GMP
GMP for TCM raw materials under NMPA; processed (dried) leech preparations are the primary commercial form (note: this differs from live-leech use in Western settings). Domestic farms in Anhui, Hubei, Jiangsu provinces dominate global supply.
Import/Export Rules
Exports require NMPA certification plus CITES Appendix II permit. Domestic distribution under TCM provincial authority oversight. China is the world's largest producer of dried medicinal leech, with major export to East Asia and Russia.
Reimbursement Context
TCM is integrated in the public-insurance schedule (国家基本医疗保险). Hirudotherapy preparations (whole-leech powder, extracts) are covered under TCM cataloguing; live-leech clinical use is rare in PRC.
Key Regulatory Documents
ASH Editorial Notes
China is the principal global source of dried medicinal leech for TCM markets — Anhui province alone produces an estimated 60–70 percent of world supply. Whitmania pigra is the dominant species, distinct from H. medicinalis used in Western markets.
Related Jurisdictions
PMDA — Japan
Japan's medicines and devices regulator — leech therapy classified within the Kampo / traditional-medicine framework under MHLW oversight, with no PMDA-issued device approval to date.
MFDS — South Korea
South Korea's drug-safety regulator (formerly KFDA) — leech therapy practised within the Korean Medicine (한의학 / Hanui) tradition; Hirudo medicinalis listed in the Korean Pharmacopoeia.
CDSCO — India
India's central drug regulator — leech therapy (Jalaukavacharana / जलौकावचारण) integrated into the official AYUSH system as part of Ayurveda Panchakarma practice.
HSA — Singapore
Singapore's health sciences regulator — leech therapy supervised under the Health Products Act 2007 with separate licensing for TCM practitioners using leeches in clinical practice.