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【CODEX翻译】接受医疗器械境外临床试验数据技术指导原则-中英双语
发布日期:2021-11-03
¥444.75
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【CODEX翻译】接受医疗器械境外临床试验数据技术指导原则



接受医疗器械境外临床试验数据技术指导原则

Technical Guideline for Acceptance of Data Derived from Overseas Clinical Trials of Medical Devices

 


为了更好满足公众对医疗器械的临床需要,促进医疗器械技术创新,根据中共中央办公厅、国务院办公厅《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》(厅字〔2017〕42号)及我国医疗器械注册管理相关要求制定本指导原则。本指导原则旨在为申请人通过医疗器械境外临床试验数据申报注册以及监管部门对该类临床试验数据的审评提供技术指导,避免或减少重复性临床试验,加快医疗器械在我国上市进程。


In order to better meet the public's clinical needs for medical devices and promote technological innovation in medical devices, according to the Opinions on Deepening the Reform of Review and Approval System and Encouraging Innovation of Drugs and Medical Devices (Office [2017] No. 42) issued by General Office of the CPC Central Committee and General Office of the State Council as well as the national requirements for medical device registration management, this Guideline is hereby formulated. This Guideline is intended to provide technical guidance for applicants to apply for registration using data derived from overseas clinical trials of medical devices and for supervision authorities to review such clinical trial data, to avoid or reduce repetitive clinical trials and speed up marketing of medical devices in China.


一、范围


I. Scope

     

      本指导原则适用于指导医疗器械(含体外诊断试剂)在我国申报注册时,接受申请人采用境外临床试验数据作为临床评价资料的工作。


This Guideline is applicable to guiding the acceptance of data derived from overseas clinical trials of a medical device (including IVD reagent) as the materials for clinical evaluation, when the applicant applies for registering the medical device in China.


      本指导原则中涉及的境外临床试验数据是指,全部或同期在境外具备临床试验开展所在国家(地区)要求条件的临床试验机构中,对拟在我国申报注册的医疗器械在正常使用条件下的安全有效性进行确认的过程中所产生的研究数据。


二、接受境外临床试验数据的基本原则


II. Basic Principles for Acceptance of Overseas Clinical Trial Data

 

(一)伦理原则


(1) Ethical Principle

 

      境外临床试验应当遵循《世界医学大会赫尔辛基宣言》确定的伦理准则。申请人同时需说明采用的临床试验开展所在国家(地区)的伦理、法律、法规所制定的规范和标准,或国际规范和标准。


Overseas clinical trials shall abide by the codes of ethics determined by the World Medical Association Declaration of Helsinki. In addition, the applicant shall describe the norms and standards specified by the ethics, laws and regulations of the country (region) where the clinical trial is carried out, or international norms and standards.

 

(二)依法原则


(2) Legal Principle

 

      境外临床试验应当在有临床试验质量管理的国家(地区)开展,并且符合我国医疗器械(含体外诊断试剂)临床试验监管要求,若临床试验所符合的临床试验质量管理文件与《医疗器械临床试验质量管理规范》(GCP)有差异,应详细说明差异内容,并充分证明差异内容不影响研究结果的真实性、科学性、可靠性及可追溯性,且能够保障受试者权益。申请人及临床试验机构应接受国家食品药品监督管理总局的监督检查。


Overseas clinical trials shall be carried out in countries (regions) that implement quality management of clinical trials and meet the Chinese regulatory requirements for the clinical trials of medical devices (including IVD reagents). Any difference existing between the clinical trial quality management documents used in the overseas clinical trials and the Good Clinical Practice for Medical Devices (GCP) shall be explained in detail, and it shall be fully demonstrated that such difference will not affect the authenticity, scientificity, reliability and traceability of the research results and that the rights and interests of the subject are protected. The applicant and clinical trial institutions shall be subject to the supervision and inspection of the China Food and Drug Administration.



      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】接受医疗器械境外临床试验数据技术指导原则



接受医疗器械境外临床试验数据技术指导原则

Technical Guideline for Acceptance of Data Derived from Overseas Clinical Trials of Medical Devices

 


为了更好满足公众对医疗器械的临床需要,促进医疗器械技术创新,根据中共中央办公厅、国务院办公厅《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》(厅字〔2017〕42号)及我国医疗器械注册管理相关要求制定本指导原则。本指导原则旨在为申请人通过医疗器械境外临床试验数据申报注册以及监管部门对该类临床试验数据的审评提供技术指导,避免或减少重复性临床试验,加快医疗器械在我国上市进程。


In order to better meet the public's clinical needs for medical devices and promote technological innovation in medical devices, according to the Opinions on Deepening the Reform of Review and Approval System and Encouraging Innovation of Drugs and Medical Devices (Office [2017] No. 42) issued by General Office of the CPC Central Committee and General Office of the State Council as well as the national requirements for medical device registration management, this Guideline is hereby formulated. This Guideline is intended to provide technical guidance for applicants to apply for registration using data derived from overseas clinical trials of medical devices and for supervision authorities to review such clinical trial data, to avoid or reduce repetitive clinical trials and speed up marketing of medical devices in China.


一、范围


I. Scope

     

      本指导原则适用于指导医疗器械(含体外诊断试剂)在我国申报注册时,接受申请人采用境外临床试验数据作为临床评价资料的工作。


This Guideline is applicable to guiding the acceptance of data derived from overseas clinical trials of a medical device (including IVD reagent) as the materials for clinical evaluation, when the applicant applies for registering the medical device in China.


      本指导原则中涉及的境外临床试验数据是指,全部或同期在境外具备临床试验开展所在国家(地区)要求条件的临床试验机构中,对拟在我国申报注册的医疗器械在正常使用条件下的安全有效性进行确认的过程中所产生的研究数据。


二、接受境外临床试验数据的基本原则


II. Basic Principles for Acceptance of Overseas Clinical Trial Data

 

(一)伦理原则


(1) Ethical Principle

 

      境外临床试验应当遵循《世界医学大会赫尔辛基宣言》确定的伦理准则。申请人同时需说明采用的临床试验开展所在国家(地区)的伦理、法律、法规所制定的规范和标准,或国际规范和标准。


Overseas clinical trials shall abide by the codes of ethics determined by the World Medical Association Declaration of Helsinki. In addition, the applicant shall describe the norms and standards specified by the ethics, laws and regulations of the country (region) where the clinical trial is carried out, or international norms and standards.

 

(二)依法原则


(2) Legal Principle

 

      境外临床试验应当在有临床试验质量管理的国家(地区)开展,并且符合我国医疗器械(含体外诊断试剂)临床试验监管要求,若临床试验所符合的临床试验质量管理文件与《医疗器械临床试验质量管理规范》(GCP)有差异,应详细说明差异内容,并充分证明差异内容不影响研究结果的真实性、科学性、可靠性及可追溯性,且能够保障受试者权益。申请人及临床试验机构应接受国家食品药品监督管理总局的监督检查。


Overseas clinical trials shall be carried out in countries (regions) that implement quality management of clinical trials and meet the Chinese regulatory requirements for the clinical trials of medical devices (including IVD reagents). Any difference existing between the clinical trial quality management documents used in the overseas clinical trials and the Good Clinical Practice for Medical Devices (GCP) shall be explained in detail, and it shall be fully demonstrated that such difference will not affect the authenticity, scientificity, reliability and traceability of the research results and that the rights and interests of the subject are protected. The applicant and clinical trial institutions shall be subject to the supervision and inspection of the China Food and Drug Administration.



      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:2021-11-03
¥444.75
立即购买
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