【CODEX】化学药品非处方药上市注册技术指导原则（征求意见稿）
化学药品非处方药上市注册技术指导原则
（征求意见稿）
Technical Guidelines for Marketing and Registration of
Over-The-Counter Chemical Drugs
(Draft for Comments)
一、概述
I. Overview
非处方药是指由国家药品监督管理部门批准的，不需要凭执业医师和执业助理医师处方，消费者可以自行判断、购买和使用的药品。非处方药具有有效性明确，安全性范围广，误用和滥用风险低，适应症和用法用量确定，且易于人群自行判断、使用与管理的特点。除此之外，非处方药在剂型、规格、口味、颜色、气味、包装等方面能够更好的满足人群个性化的用药需求。
Over-the-counter (OTC) drugs refer to drugs approved by the NMPA, which are not required to be prescribed by medical practitioners or assistant medical practitioners, and can be purchased and used by consumers at their own discretion. OTC drugs are characterized by clear effectiveness, a wide range of safety, low risk of misuse and abuse, fixed indications and usage, and easy to be judged, used and managed by people at their own discretion. In addition, OTC drugs can better meet the individualized drug demands of the population in terms of dosage form, strength, taste, color, odour, and package.
《药品注册管理办法》（国家市场监督管理总局令第27号）明确规定，处方药和非处方药实行分类注册和转换管理，符合以下情形之一的，可以直接提出非处方药上市许可申请：（一）境内已有相同活性成分、适应症（或者功能主治）、剂型、规格的非处方药上市的药品；（二）经国家药品监督管理局确定的非处方药改变剂型或者规格，但不改变适应症（或者功能主治）、给药剂量以及给药途径的药品；（三）使用国家药品监督管理局确定的非处方药的活性成份组成的新的复方制剂；（四）其他直接申报非处方药上市许可的情形。
The Provisions for Drug Registration (Order No. 27 of the State Administration for Market Regulation) clearly stipulates that prescription drugs and OTC drugs shall be subject to classified registration and conversion management. Under any of the following circumstances, an application for marketing authorization of an OTC drug may be directly filed: (1) There is already an OTC drug marketed with the same active ingredients, indications (or functions), dosage forms and strengths as the drug in the territory; (2) The dosage form or strength is changed for an OTC drug determined by NMPA, but the indication (or function), dosage or route of administration of the drug is not changed; (3) A new compound preparation composed of active ingredients of an OTC drug determined by NMPA is used; (4) Other circumstances for directly filing an application for OTC drug marketing authorization.
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