International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

日内瓦，2020 年 10 月 1 日 资助机会 RFA-FD-21-002 项目概要 国际协调委员会 药品技术要求 人类使用 国际技术要求协调委员会 人用药品 (ICH) 是一个国际非营利组织 其目的是通过国际协调来促进公共卫生 有助于及时推出新药的技术要求 持续向患者提供批准的药物，以预防 不必要地重复人体临床试验，以开发、注册和 以高效、低成本的方式生产安全、有效、高质量的药品 有效的方式，并尽量减少使用动物试验而不 损害安全性和有效性。 ICH 工作的一个主要成果是制定了统一的技术指南 质量、安全和功效主题。 ICH 指南代表了商定的科学依据 满足药品注册技术要求的指南。 每个 ICH 监管成员都应根据 ICH 实施 ICH 指南 根据其国家/地区要求的程序，阶段为 所有 ICH 指南的实施也取决于成员加入的时间 ICH。监测国际协调的进展并协调努力 这方面是 ICH 的一个重要关注点。作为实现全球协调一致努力的一部分 ICH 指南的实施，ICH 还致力于确保高质量 根据 ICH 中概述的科学和监管原则提供培训 指导方针。 ICH秘书处提供行政和项目管理 对这些活动的支持。 迄今为止，还有 65 个关于安全、质量和功效主题的协调一致的 ICH 指南 随着多学科主题的发展。

Geneva, 1 October 2020 Funding Opportunity RFA-FD-21-002 Project Summary International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an international non-profit organisation the purpose of which is to promote public health through international harmonisation of technical requirements that contributes to the timely introduction of new medicines and continued availability of the approved medicines to patients, to the prevention of unnecessary duplication of clinical trials in humans, to the development, registration and manufacturing of safe, effective, and high quality medicines in an efficient and cost- effective manner, and to the minimisation of the use of animal testing without compromising safety and effectiveness. A major output of ICH’s work is the development of harmonised technical guidelines on Quality, Safety and Efficacy topics. The ICH Guidelines represent agreed-upon scientific guidance for meeting technical requirements for registration of pharmaceutical products. Each ICH Regulatory Member is expected to implement ICH Guidelines in line with ICH Procedures according to its national/regional requirements, with the stage of implementation of all ICH Guidelines also being dependent on when a Member joined ICH. Monitoring the progress of international harmonisation and coordinating efforts in this regard is an important ICH focus. As part of its effort to achieve global harmonised implementation of ICH Guidelines, ICH is also working on ensuring that high quality training is available based upon scientific and regulatory principles outlined in the ICH Guidelines. The ICH Secretariat provides administrative and project management support for these activities. To-date 65 harmonised ICH Guidelines on Safety, Quality and Efficacy topics, as well as Multidisciplinary topics have been developed.