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ICH

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use is a joint initiative involving both regulators and research-based industry focusing on the technical requirements for medicinal products containing new drugs

ICH Coordinators

Are nominated by each of the six co-sponsors and are fundamental to the smooth running of the ICH. An ICH Coordinator acts as the main contact point with the ICH Secretariat. Due to the structural differences within the EU and MHLW, ICH Technical Coordinators are also designated from the EMA and PMDA respectively. They support their respective ICH Coordinators and facilitate every action of the Steering Committee members in the region, mainly by applying their scientific knowledge. Their roles include acting as a contact point between the experts within EMA or PMDA and the ICH Coordinator at the main regulatory body, and as a contact point with the ICH Secretariat

ICH GCG

Global Cooperation Group is a subgroup of the ICH Steering Committee and is composed of one representative from each of the six parties on the ICH Steering Committee, plus the IFPMA. Three Observers (WHO, Health Canada and EFTA) are also part of the GCG. Other Regional Harmonisation Initiatives (RHIs), as well as Drug Regulatory Authorities (DRAs) and Departments of Health (DoHs) have also been invited to designate permanent representatives to the GCG

ICH Interested Parties

Those organisations that are expected to implement or to be regulated by the outcome of ICH efforts (World Self-Medication Industry -WSMI, International Generic Pharmaceutic Alliance - IGPA, and other interested parties as determined by the Steering Committee over time)

ICH Observers

European Free Trade Association (EFTA) - currently represented by Swissmedic (Swiss Agency for Therapeutic Products), Health Canada and World Health Organization (WHO), have been associated with the ICH process from the beginning to act as a link with non-ICH countries and regions

ICH Steering Committee

Is the body that governs the ICH, determines the policies and procedures for ICH, selects topics for harmonisation and monitors the progress of harmonisation initiatives. Each of the six Parties has two seats on the ICH Steering Committee. Each of the Observers nominates non-voting participants to attend the ICH Steering Committee Meetings, IFPMA also participates as a non-voting member

IFPMA

International Federation of Pharmaceutical Manufacturers and Associations, a non-voting member of the ICH

IGPA

International Generic Pharmaceutical Alliance, and one of the ICH Interested Parties

IWG

Implementation Working Group; tasked to develop Q&As to facilitate implementation of existing Guidelines

Informal Working Group

Is either an informal Expert Working Group (EWG) or Implementation Working Group (IWG) formed prior to any official ICH harmonisation activity with the objectives of developing/finalizing a Concept Paper, as well as developing a Business Plan