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Ich guidance1/4/2024 ![]() The MedDRA Management Committee (MC) has responsibility for direction of MedDRA, ICH’s standardised medical terminology. The ICH Management Committee (MC) is the body that oversees operational aspects of ICH on behalf of all Members, including administrative and financial matters and oversight of the Working Groups (WGs). Member representatives appointed to the Assembly are supported by ICH Coordinators who represent each Member to the ICH Secretariat on a daily basis. It adopts decisions in particular on matters such as on the adoption of ICH Guidelines, admission of new Members and Observers, and the ICH Association’s work plans and budget. The ICH Assembly brings together all Members and Observers of the ICH Association as the overarching governing body of ICH. The new Assembly met for the first time on 23 October 2015. The ICH Association established an Assembly as the over-arching governing body with the aim of focusing global pharmaceutical regulatory harmonisation work in one venue that allows pharmaceutical regulatory authorities and concerned industry organisations to be more actively involved in ICH’s harmonisation work. ![]() The aim of these reforms was to transform ICH into a truly global initiative supported by a robust and transparent governance structure. In 2015, ICH underwent several reforms and changed its name to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use while becoming a legal entity in Switzerland as a non-profit association. Since the new millennium, ICH's attention has been directed towards extending the benefits of harmonisation beyond the founding ICH regions. ICH had the initial objective of coordinating the regulatory activities of the European, Japanese and United States regulatory bodies in consultation with the pharmaceutical trade associations from these regions, to discuss and agree the scientific aspects arising from product registration. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. In the 1980s the European Union began harmonising regulatory requirements.
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