BOTANICAL DRUGS / A GLOBAL DEVELOPMENT PERSPECTIVE

Start with a disease.
Discover botanical candidates.

For global botanical drug development, start with a defined modern medical indication and use VMED-OS to identify new botanical candidates. Investigate pharmacology, safety and quality to select developable products and plan clinical development under each target market’s requirements.

Define the indication. Expand the candidate space.

Start with patients, current treatment and unmet clinical needs. Connect disease mechanisms and targets with compound and botanical evidence. Candidates may include new uses of established medicinal plants or plant resources with a credible research basis.

Define

Specify the population, treatment goal and measurable endpoints.

Predict

Compare materials, plant parts and extracts against mechanisms and evidence.

Test

Evaluate prioritized candidates through reproducible pharmacology, safety and quality studies.

Six questions from candidate selection to development.

01 / Which clinical need?

Define the modern medical indication, population, treatment gaps and intended differentiation. Use measurable outcomes to guide selection.

02 / Which botanical candidates?

Use the model to connect botanical–compound–target–indication evidence. Compare direction of effect, evidence strength and conflicting findings to prioritize experiments.

03 / What is the product?

Specify species, plant part, extraction process, composition, dosage form and administration so the candidate can be prepared reproducibly.

04 / Does the evidence support progression?

Test activity in disease-relevant models. Assess dose, exposure, toxicity and interactions, including comparability with any prior human use.

05 / Can consistency be maintained?

Connect material sourcing, chemical characterization, manufacturing controls and biological assays with stability, scale-up and sustainable supply.

06 / How will development fit the market?

Assess classification and submission options in the intended market. Plan the population, comparator, endpoints and clinical supplies, identifying additional studies early.

Predict, test and refine the next decision.

VMED-OS integrates evidence, proposes mechanistic hypotheses and compares candidates. Experimental teams characterize materials and investigate activity and safety, feeding results into the next selection cycle.

A newly proposed botanical candidate is a research candidate, not automatically a Class 1.3 new medicinal material under Chinese regulations. Candidate prediction does not establish clinical efficacy.

Global development follows local requirements.

Global botanical drugs is a Veritas research direction. Each product must meet the drug development and registration requirements of its intended country or region.

United States / FDA

For eligible botanical products, plan quality, nonclinical and clinical evidence across IND and NDA stages, with attention to therapeutic consistency. Highly purified natural substances generally fall outside this botanical pathway.

Europe / National authorities

Assess traditional-use, well-established-use, or standalone/mixed applications according to the product and evidence. Novel candidates or indications do not automatically qualify for simplified traditional-use registration.