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

2015年12月14日，日内瓦 融资机会RFA-FD-15-014 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， 损害安全性和有效性。 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指南 在欧盟、日本、美国、加拿大、瑞士和其他地区。每个ICH 监管成员根据其国家/地区要求实施ICH指导原则 要求. 迄今为止，已有60多项关于安全性、质量和有效性主题的协调ICH指南， 多学科的课题已经形成。

Geneva, 14 December 2015 Funding Opportunity RFA-FD-15-014 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 within the European Union, Japan, USA, Canada, Switzerland and beyond. Each ICH Regulatory Member implements the ICH Guidelines according to its national/regional requirements. To-date over 60 harmonised ICH Guidelines on Safety, Quality and Efficacy topics, as well as Multidisciplinary topics have been developed.