1.1 / Compound TCM preparations
Formulas combining multiple prepared medicinal materials, extracts or other components under TCM theory. Investigate formulation rationale, overall activity, component contributions and quality controls.
INNOVATIVE TCM DRUGS / CHINA CLASS 1Build on TCM knowledge.
Build on TCM knowledge.
Develop meaningful innovations.
Focus on Classes 1.1, 1.2 and 1.3 under China’s current innovative TCM drug framework. Connect TCM theory, human-use experience and clinical research, with AI supporting candidate design, mechanistic research and experimental decisions.
Three subclasses define the research material.
1.2 / Extracts and their preparations
Extracts obtained from a single plant, animal, mineral or other material, and their preparations. Study source material, extraction, composition, activity and quality standards.
1.3 / New medicinal materials and their preparations
Materials not covered by national drug standards, drug registration standards or provincial medicinal-material standards, and their preparations; also new medicinal parts of the original plants or animals of materials covered by these standards. Study identity, supply, safety, pharmacology and quality.
NMPA TCM registration classification and dossier requirements ↗
Build the evidence around clinical value.
Define the intended therapeutic use, population and treatment goal. Assess TCM theory and relevant human-use experience alongside quality, nonclinical and clinical studies. Maintain a clear link between composition, manufacturing and study materials as benefit, risk and quality are evaluated.
Theory and experience
Assess therapeutic rationale and comparability with prior use.
Quality and nonclinical studies
Investigate composition, mechanisms, pharmacology, safety, process and quality.
Clinical research
Evaluate the proposed clinical value using appropriate designs and endpoints.
Use AI to support testable TCM innovation.
For formulas, compare component rationale and contributions. For extracts, connect composition, mechanisms and process studies. For new medicinal materials, organize provenance, traditional knowledge and safety or activity signals. Test candidates experimentally and update priorities from the results.
Let product characteristics determine classification.
Class 1 eligibility depends on the applicable new-formula criteria, clinical value and overseas marketing status. Preparations derived from ancient classical formulas have a separate Class 3 pathway. Global botanical and Chinese innovative TCM programs may share research resources, while classification and evidence requirements are assessed for each intended market.
Discuss innovative TCM research ↗