TCM, AYUSH & Kampo traditional-medicine frameworks
Traditional Medicine Regulatory Frameworks — TCM, Ayurveda, Kampo, Western Herbal · TCM China NMPA · Ayurveda AYUSH · Japanese Kampo · EU THMPD · UK MHRA THR
Term — TCM, AYUSH and Kampo traditional-medicine frameworks: traditional medicine frameworks — TCM under China NMPA (Chinese Pharmacopoeia, classical formulae 经典名方), Ayurveda/Unani/Siddha under India AYUSH (Ayurvedic Pharmacopoeia of India, Schedule T GMP), Japanese Kampo under PMDA (148 standard MHLW formulations), Western Herbal under EU THMPD 2004/24/EC (30-year traditional use including 15 years in EU) and UK MHRA THR — with per-market positioning discipline because authorisation does not transfer cross-market.
Traditional medicine frameworks regulate herbal and natural products with long-standing customary use across major cultural medical systems. China NMPA regulates TCM as Chinese Medicine under the Drug Administration Law with Chinese Crude Drugs, Decoction Pieces, Chinese Medicine Preparations and Innovative Chinese Medicines classification, classical formulae fast-track pathway for traditional formulations from authoritative dynastic medical canon, and Chinese Medicine GMP with paozhi 炮制 traditional processing standards. India Ministry of AYUSH regulates Ayurveda, Yoga and Naturopathy, Unani, Siddha, Sowa Rigpa and Homoeopathy under the Drugs and Cosmetics Act with Schedule T GMP and Ayurvedic/Unani/Siddha Pharmacopoeia of India monographs covering 600+ single drugs and compound formulations. Japan PMDA regulates Kampo with Japanese Pharmacopoeia Kampo Crude Drug monographs and MHLW 148 standard Kampo formulations under national health insurance. EU Traditional Herbal Medicinal Products Directive 2004/24/EC establishes simplified registration for products with 30+ years traditional use including 15+ years in EU, with HMPC Community Herbal Monographs as reference and Member State registration. UK MHRA Traditional Herbal Registration scheme operates the equivalent UK post-Brexit framework. Cross-market positioning discipline — authorisation in one framework does not transfer; products marketed cross-region operate parallel market-specific regulatory positionings with market-specific claim copy. Heavy-metal content in Ayurvedic Rasashastra preparations is a recurrent export-market regulatory issue.
- China Drug Administration Law
- India Drugs and Cosmetics Act Schedule T
- Japanese Pharmacopoeia
- Directive 2004/24/EC
- UK MHRA THR
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