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.

Regulatory anchors

China Drug Administration Law
India Drugs and Cosmetics Act Schedule T
Japanese Pharmacopoeia
Directive 2004/24/EC
UK MHRA THR

Industries that live with this

Dietary Supplements Pharmaceutical

How V5 handles it

Score your compliance gap — then download the validation pack.

A guided self-assessment walks you against the regulator clauses that apply to your industry. The validation pack — IQ/OQ/PQ scripts, traceability matrix, risk assessment, intended-use statement — generates from the same evidence so you can hand it to an auditor on day one.

Document control with hard kiosk-level training enforcement.

Versioned SOPs are only useful if operators are actually trained on the current version. V5 enforces it at the kiosk.

Labels — designed, approved, printed and audited in one place.

Most regulated manufacturers run a label tool (NiceLabel, Loftware, BarTender) bolted next to their QMS — versions drift, reprints aren't audited, and 211.122 / 111.130 / 820.120 findings follow. V5 puts the designer, the approval workflow, the print agent and the reprint audit trail in one place — the same place that holds the BMR.

Related terms

Heavy Metals