药品注册知识 1：国内外原料药定义知多少？

ICH Q7

Active Pharmaceutical Ingredient (API) (or Drug Substance)

Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.

活性药物成份（API）（或原料药）

任何旨在供生产一种药物（医疗用品）制剂，并作为其活性成份的物质或混合物。这类物质旨在疾病的诊断、治愈、缓解、治疗或预防以及影响人体的结构和功能等方面发挥药理作用或其它的直接效应。

FDA DMF Guidance

Active pharmaceutical ingredient (API): Any substance intended for incorporation into a finished drug product and intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect  the structure or any function of the body; does not include intermediates used in the synthesis of the substance (21 CFR 207.1).

活性药物成分（API）：任何准备加入制剂起到药物活性或其他直接影响诊断、治愈、缓解、治疗或预防疾病作用，或影响人体结构或功能的物质，不包括此类物料合成过程中所用的中间体。（21 CFR 207.1）

Drug substance（DS）: An active ingredient that is intended to furnish pharmacological activity or another direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body but does not include intermediates used in the synthesis of such an ingredient (§ 314.3(b)).

药用物质（DS）：用于提供药物活动或具有其他直接影响诊断、治愈、缓解、治疗或预防疾病作用，或影响人体结构或功能的活性成分，不包括原料药合成过程中所用中间体。（§ 314.3(b))

FDA GDUFA

Active pharmaceutical ingredient(as defined by GDUFA):

(A) A substance, or a mixture when the substance is unstable or cannot be transported on its own, intended

一种物质，或当该物质不稳定或无法单独运输时进行混合后的混合物，用于：

 (i) to be used as a component of a drug; and 用作一种药物的成分；以及

 (ii) to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the human body; or 用于修饰药性活动或在诊断、治愈、缓解、治疗或防治疾病时起到直接作用，或者对人体结构或功能有影响；或

 (B) a substance intended for final crystallization, purification, or salt formation, or any combination of those activities, to become a substance or mixture described in subparagraph (A). 用于最终结晶、精制或成盐，或其它多个活动，成为上述（A）段中所述的物质或混合物的物质。

EU GMP及国内GMP有关原料药的术语定义，与ICH Q7保持一致。在ICH Q7中API与DS是或者关系，两者是同一含义。不管是原料药、活性药物成分还是药用物质，其本质是一样的。

中美欧用语习惯各不相同，欧盟习惯用Active Substance，美国习惯用Drug Substance，对原料药的理解大同小异。小伙伴们学会了吗？

       文章来源：允咨GMP制药技术

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