Grounded in scientific evidence.
Exploring innovation in natural medicines.
Regulatory guidance
Guidance for botanical INDs and subsequent NDAs, supporting staged product, CMC, nonclinical and clinical planning.
FDA guidance provides nonbinding recommendations. Development paths depend on the specific product.
Product definition and consistency
Supports an evidence strategy connecting raw materials, chemical/manufacturing controls, biological assays and clinical data.
Highly purified natural substances generally fall outside the botanical definition. Evaluate botanical and chemical pathways separately.
Network medicine for herb–symptom relationships
Network relationships and observational clinical data support research into herb–symptom associations and opportunity prediction.
Associations and predictions provide research leads. Efficacy in new indications requires further validation.
European herbal medicines: match the pathway to the evidence
EMA distinguishes traditional use, well-established use and standalone/mixed applications. Assess the product under the intended country’s requirements; a new indication does not automatically qualify for traditional-use registration.
China Class 1 innovative TCM drugs: 1.1, 1.2 and 1.3
NMPA Announcement No. 68 of 2020 sets out TCM registration classes. Class 1 covers innovative drugs; ancient classical formula preparations have a separate Class 3 pathway.
Special provisions for TCM registration
NMPA Announcement No. 20 of 2023 emphasizes clinical value and an evidence framework combining TCM theory, human-use experience and clinical trials.