注册
CN
【CODEX翻译】化学药品非处方药上市注册技术指导原则(征求意见稿)-中英双语
发布日期:2021-10-12
¥749.28
立即购买

 【CODEX翻译】化学药品非处方药上市注册技术指导指导原则(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.



      CODEX北京科译翻译有限公司是一家专业提供生命科学翻译和本地化服务的公司,作为中国专业的生命科学翻译公司之一以及国内为数不多的通过国际ISO17100: 2015认证的医学翻译提供商,CODEX科译拥有更多的医学资深语言专家,能实现40多种语言对的互译,接受更高难度的医学领域的项目挑战,并在最短时间内适应以给出最合理的解决方案。保证最高质量,100%按时交付,高效、完善的售后保障是CODEX科译给客户的用心承诺。

CODEX is a leading provider of cross-border communications based in Beijing. With our exclusive database in life science, and ISO 17100:2015 certified, CODEX has the required expertise and experience in localization, documentation, and medical literature to deliver a full range of end-to-end content and consulting services in many languages. We closely work with clients to deliver solutions to the challenges of engaging markets, consumers, and regulatory and patent environments worldwide.


      以上是免费内容,查看更多可立即购买

 【CODEX翻译】化学药品非处方药上市注册技术指导指导原则(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.



      CODEX北京科译翻译有限公司是一家专业提供生命科学翻译和本地化服务的公司,作为中国专业的生命科学翻译公司之一以及国内为数不多的通过国际ISO17100: 2015认证的医学翻译提供商,CODEX科译拥有更多的医学资深语言专家,能实现40多种语言对的互译,接受更高难度的医学领域的项目挑战,并在最短时间内适应以给出最合理的解决方案。保证最高质量,100%按时交付,高效、完善的售后保障是CODEX科译给客户的用心承诺。

CODEX is a leading provider of cross-border communications based in Beijing. With our exclusive database in life science, and ISO 17100:2015 certified, CODEX has the required expertise and experience in localization, documentation, and medical literature to deliver a full range of end-to-end content and consulting services in many languages. We closely work with clients to deliver solutions to the challenges of engaging markets, consumers, and regulatory and patent environments worldwide.


      以上是免费内容,查看更多可立即购买
发布日期:2021-10-12
¥749.28
立即购买
我们的优势
16年医疗、知识产权领域翻译经验
16年医疗、知识产权领域翻译经验
自成立以来,CODEX 一直深耕医疗、知识产权领域翻译,高品质的翻译和服务,是CODEX得以持续发展的源动力。
专业的精英团队
专业的精英团队
CODEX的团队是由留学归国人员、重点高校毕业的研究生、专业的母语籍译员以及医学行业的专家顾问组成。
权威的质量认证体系
权威的质量认证体系
通过ISO 17100:2015质量认证,以及ISO 9001:2015质量管理体系认证,服务多家国际著名的医药企业。
严格的管控流程
严格的管控流程
CODEX制定了完善的翻译质量保证体系和系统化的运作流程,严格采取一译、二改、三校、四审的工作程序。
绝佳的员工素质
绝佳的员工素质
我们中的每一位都经过严格的考核和挑选,精通医学翻译工作,形象佳责任心强,并严格遵循保密制度。
客户支持
客户支持
“精益求精,至善至美”科译质量和实力以及严格的保密制度倾心为您服务。
联系我们
CODEX科译在您身边

北京科译翻译有限公司

400-136-8786

我们将全天候为您服务
我们是谁
16年来,CODEX是一直致力于提供生命科学翻译和本地化服务的公司,是国内为数不多的通过国家ISO17100:2015认证的医学翻译提供商。
会员注册
发送验证码
注册
已有账号?点击登录
账号登录
短信登录
登录
没有账号?点击注册
发送验证码
登录
没有账号?点击注册
扫码二维码
CODEX微信公众号
添加微信
CODEX翻译客服
联系我们
400-136-8786
邮箱
Info@codex-trans.com