【CODEX翻译】植入式给药装置注册技术审查指导原则-中英双语

【CODEX】植入式给药装置注册技术审查指导原则

植入式给药装置注册技术审查指导原则

Guideline for Technical Review of Implantable Drug Delivery Device Product Registration

      本指导原则旨在帮助和指导注册申请人对植入式给药装置注册申报资料进行准备，以满足技术审评的基本要求。同时有助于审评机构对该类产品进行科学规范的审评，提高审评工作的质量和效率。

This Guideline is intended to help and instruct the registration applicant to prepare application dossiers for implantable drug delivery device registration, so as to meet the basic requirements for technical review. It also helps the technical reviewing institution to conduct a scientific and standardized review of such products, improving the quality and efficiency of the review.

      本指导原则是对植入式给药装置注册申报资料的一般要求，注册申请人应依据具体产品的特性对注册申报资料的内容进行充实和细化。注册申请人还应依据具体产品的特性确定其中的具体内容是否适用，若不适用，需具体阐述其理由及相应的科学依据。

The Guideline is the general requirements for the application dossiers for implantable drug delivery device registration. The applicant shall supplement and detail the contents of the registration application dossiers based on the characteristics of specific products. The applicant shall also determine whether the specific content of this Guideline is applicable based on the features of specific products and specify reasons and relevant scientific basis if not.

      本指导原则是对注册申请人和审评人员的指导性文件，但不包括注册审批所涉及的行政事项，亦不作为法规强制执行，应在遵循相关法规的前提下使用本指导原则。如果有能够满足相关法规要求的其他方法，也可以采用，但是需要提供详细的研究资料和验证资料。

This Guideline is a guiding document for the applicant and the reviewer, which excludes the administrative matters involved in registration approval and shall not be enforced as regulations. It shall be used on the premise of complying with relevant regulations. Other methods (if any) that can meet the requirements of relevant regulations may also be adopted, but detailed research and verification data shall be provided.

      本指导原则是在现行法规和标准体系以及当前认知水平下制定的，随着法规和标准的不断完善，以及科学技术的不断发展，本指导原则相关内容也将进行适时的调整。

This Guideline is formulated based on the current regulations, standard system and present cognitive level. Along with constant improvement of regulations and standards as well as continuous development of science and technology, the relevant content in this Guideline will be revised timely.

      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。