The 2027 BCPT Perspectives on Studies Involving Natural Products, Traditional Chinese Medicine and Systems Pharmacology

Abstract

ABSTRACT Natural products, including isolated compounds, complex extracts, traditional medicinal preparations and marine, microbial, fungal and animal‐derived materials, remain important sources of therapeutic agents and pharmacological discovery. However, variation in biological source materials, preparation methods, chemical composition and experimental design may compromise reproducibility and interpretation. This guideline presents the requirements of Basic & Clinical Pharmacology & Toxicology for studies involving natural products and their semisynthetic or biotransformed derivatives. It provides recommendations for documenting scientific and ethnopharmacological rationale, taxonomy, authentication, provenance, sustainable and lawful sourcing, extraction, chemical characterisation, dosing, bioactivity, safety and data accessibility. Particular emphasis is placed on studying the preparation actually administered, using pharmacologically relevant concentrations and doses, controlling vehicle effects and assay interference and aligning mechanistic and therapeutic claims with the supporting evidence. Complex mixtures do not necessarily need to be reduced to a single active constituent; however, their composition must be adequately characterised, and claims concerning individual constituents, additivity, synergy or antagonism require experimental substantiation. Computational, network and systems‐pharmacology analyses should be transparent and reproducible, with experimental validation of central predictions. These recommendations apply equivalent standards to natural products and other interventions while recognising the additional information required to define complex biological materials and improve overall translational relevance.