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 国际协调发展理事会 医用药品技术要求 人类使用 国际协调技术要求理事会 人用药品(ICH)是一个国际非营利性组织， 其目的是通过国际协调促进公共卫生 有助于及时推出新药的技术要求和 继续向患者提供经批准的药物，以预防 不必要的人体临床试验重复，对开发、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，并最大限度地减少使用动物试验而没有 损害了安全性和有效性。 非物质文化遗产工作的一项主要成果是制定了关于以下问题的统一技术准则 质量、安全和功效主题。非物质文化遗产指南代表了公认的科学 满足药品注册技术要求的指南 在欧盟、日本、美国、加拿大、瑞士和更远的地方。每一次非物质文化遗产 监管成员根据其国家/地区执行非物质文化遗产指导方针 要求。 到目前为止，关于安全、质量和功效主题的60多个非物质文化遗产协调指南，如 此外，还开发了多学科课题。

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.