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

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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.