Tiêu đề 5. GOOD CLINICAL PRACTICE – ICH, GCP.pdf ✅

PHARMD GURU Page 1 ICH GUIDELINES ICH: International Conference on Harmonization of technical requirements for registration of pharmaceuticals for human use. The purpose of ICH is to reduce (or) obviate the need to duplicate the testing carried out during the research and development of new medicines by recommending ways to achieve greater harmonization in the interpretation and application of technical guidelines and requirements for product registration. ICH-STRUCTURE  ICH is an initiative that has been jointly undertaken by both regulators and pharmaceutical industry.  Technical requirements for developing new drugs have been the focus of ICH. Hence the scope of ICH is mainly confined to Western Europe, US and Japan, where bulk of new drugs are developed.  ICH is administered by ICH steering committee, which is supported by ICH Secretariat.  ICH Secretariat is supported by International Federation of pharmaceutical manufacturers Association (IFPMA). ICH PARTICIPANTS FOUNDER MEMBERS: ICH comprises of six founder members representing the regulatory bodies and the research based industry in EU, Japan and the US. GOOD CLINICAL PRACTICE – ICH, GCP
PHARMD GURU Page 2 EU : European Union EFPIA : European Federation of pharmaceutical industries and associations. MHLW : Ministry of Health, Labor and Welfare (Japan). JPMA : Japan pharmaceutical manufacturers Association. FDA : US Food and Drug Administration. PhRMA : Pharmaceutical Research and Manufacturers of America. ICH COORDINATORS:  Each of six groups has a designed coordination, who acts as the main point of contact with the ICH Secretariat.  Each party has an established contact network of experts within their own region to ensure that they reflect the views and policies of co-sponsor, they represent in various discussions. OBSERVERS: In addition to expert groups, ICH has observers to act as a link with non-ICH countries and regions. Ex: WHO, EFTA (European free trade area) ICH SECRETARIAT:  It is supported by IFPMA and operates from its offices in Geneva.  It is mainly concerned with: 1) Preparations for and documentation of meetings of the steering committee. 2) Coordination of preparations for meeting of the expert working groups & six party drafting groups. IFPMA (INTERNATIONAL FREEDOM OF PHARMACEUTICAL MANUFACTURERS ASSOCIATION):  It represents the research based pharmaceutical industry and other manufacturers of prescription medicines in 56 countries worldwide.  IFPMA runs the ICH Secretariat.