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

国际人用药品技术要求协调委员会

• 批准号: 10368092
• 负责人: Dawn Ronan Blanc
• 金额: $ 28.37万
• 依托单位: ICH
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-04-01 至 2026-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10368092
• 关键词: International; Council; Harmonisation; Technical; Requirements

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.

2020年10月1日，日内瓦 资助机会RFA-FD-21-002 项目摘要 国际协调理事会 药品技术要求 人用 技术要求国际协调理事会 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， 有助于及时引进新药的技术要求， 继续向患者提供批准的药物， 不必要的重复人体临床试验，以开发，注册和 以高效和低成本的方式生产安全、有效和高质量的药物， 有效的方式，并尽量减少使用动物试验， 危及安全性和有效性。 ICH工作的一项主要成果是制定了以下方面的协调技术指南： 质量、安全性和有效性主题。ICH指导原则代表了公认的科学 符合药剂制品注册技术要求的指引。 每个ICH监管成员都应按照ICH的要求实施ICH指导原则。 根据其国家/区域要求制定的程序， 所有ICH指导原则的实施也取决于成员何时加入 ICH。监测国际协调的进展情况，并协调以下方面的工作： 这是ICH的一个重要关注点。作为实现全球协调一致的努力的一部分， 为了实施ICH指南，ICH还致力于确保 根据ICH中概述的科学和监管原则提供培训 指南ICH秘书处提供行政和项目管理 支持这些活动。 迄今为止，还有关于安全性、质量和有效性主题的65项协调ICH指导原则， 随着多学科课题的发展。