权益分类	功能权益	普通用户	{{item.name}}会员
{{category.name}}	{{benefitItem.name}}

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

基本信息

批准号：
10275774
负责人：
Dawn Ronan Blanc
金额：
$ 34.03万
依托单位：
ICH
依托单位国家：
美国
项目类别：
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/10275774
关键词：
International Council Harmonisation Technical Requirements

项目摘要

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。每个非物质文化遗产监管成员应按照非物质文化遗产实施非物质文化遗产指南根据其国家/区域要求的程序，阶段为所有非物质文化遗产准则的实施也取决于成员何时加入我也是。监测国际协调的进展情况并协调#年的努力这方面是非物质文化遗产的一个重要重点。作为其实现全球协调的努力的一部分在实施非物质文化遗产准则的同时，非物质文化遗产也在努力确保高质量根据非物质文化遗产概述的科学和管理原则提供培训指导方针。非物质文化遗产秘书处提供行政和项目管理支持这些活动。到目前为止，关于安全、质量和功效主题的65项非物质文化遗产协调指南也随着多学科课题的发展。