Contains Nonbinding Recommendations
Draft — Not for Implementation 包含不具约束力的建议 草案 — 不用于实施
provided or referenced in the IND, the sponsor should provide a comparison of the investigational botanical drug product to be used in the IND and the botanical drug product(s) used in the referenced studies (e.g., chemical identification and quantification of active or chemical constituents in the drug substance, drug product composition and formulation). Likewise, when the source and manufacturing process of the botanical raw material, drug substance, or drug product are changed during development, the sponsor should provide a comparison of the previous and new sources and manufacturing processes, because seemingly minor changes in the source and/or process may result in a meaningful difference in the clinical effects and raise the question about the applicability of earlier pharmacological, nonclinical, and clinical data.
如果在研究用新药申请（IND）中提供或引用了之前可用的非临床和/或临床数据，发起方应提供在研究用新药申请（IND）所使用的研究用植物药品和所引用的研究中所采用的植物药品（例如，原料药活性成分或化学成分的化学鉴定和定量检测，药品组成和处方）的比较。同样地，在研发期间，当植物原药材、原料药或药品的供货来源和制造工艺发生变更时，发起方应提供之前和新来源及制造工艺的比较，原因在于供货来源和/或工艺上看似微小的变更可能导致临床效果上有意义的变化，并提出之前的药理学、非临床和临床数据适用性的问题。
If there is uncertainty about whether different batches of the drug substance are similar, bridging studies (e.g., chemical identification and quantification of active or chemical constituents in the drug substance, biological assay, and/or other nonclinical studies) may be warranted to demonstrate that the drug substances used in various stages of development are sufficiently similar to justify reliance on previous nonclinical and clinical testing results. Sufficient quantities of the botanical raw material and drug substance from the different batches should be retained for future chemi