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Glossary
APEC
Asia-Pacific Economic Cooperation, and one of the Regional Harmonisation Initiatives (RHIs)
ASEAN
Association of Southeast Asian Nations, and one of the Regional Harmonisation Initiatives (RHIs)
Brainstorming Group
Is a group that discusses the need for harmonisation within specific scientific domains. The outcome of Brainstorming sessions is recommendations for topics for ICH harmonisation, for Steering Committee consideration
Business Plan
After consideration of a Concept Paper, the Steering Committee may request the development of a Business Plan, outlining the costs and benefits of harmonising the topic proposed by the Concept Paper. The Business Plan is complementary to the Concept Paper and focuses in particular on regulatory feasibility
CTD
Common Technical Document
Concept Paper
Describes the perceived problem and the issues to be resolved, and is the trigger of all ICH activities. A Concept Paper for a new harmonisation activity can be submitted by any ICH party or Observer to the Steering Committee
Considerations Document
Are developed by discussion groups i.e., Gene Therapy Discussion Group (GTDG), and ICH & Women Discussion Group. These documents do not undergo the formal step sign-off approval, but do require discussion and endorsement by the Steering Committee
Discussion Group
Is a group established to discuss specific scientific considerations or views i.e., Gene Therapy Discussion Group (GTDG), and ICH & Women Discussion Group
EFPIA
European Federation of Pharmaceutical Industries and Associations, and one of the six ICH Parties
EFTA
European Free Trade Association, and one of the ICH Observers - currently represented by Swissmedic (Swiss Agency for Therapeutic Products)
EMA
European Medicines Agency
ESTRI
Electronic Standards for the Transfer of Regulatory Information and Data
EU
European Union (EU is represented by the European Commission and EMEA and its Experts Committees), and is one of the six ICH Parties
EWG
Expert Working Group; charged with developing a harmonised guideline that meets the objectives in the Concept Paper and Business Plan
eCTD
Electronic Common Technical Document
GCC
Gulf Cooperation Council, and one of the Regional Harmonisation Initiatives (RHIs)
GTDG
Gene Therapy Discussion Group
Guidelines
The main focus of the ICH process is the preparation of harmonised Guidelines that are adopted in the three ICH regions - EU, US and Japan. Countries ouside of ICH may also use the ICH Guidelines within their own countries if they so wish
Health Canada
Health Canada is the Canadian Federal department for health, and one of the ICH Observers
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 EMEA 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 EMEA 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
JMO
Japanese Maintenance Organisation (is a partner of the MSSO and is responsible for maintaining and distributing MedDRA in Japan)
JPMA
Japan Pharmaceutical Manufacturers Association, and one of the six ICH Parties
MHLW
Ministry of Health, Labour and Welfare, Japan, and one of the six ICH Parties
MHRA
Medicines and Healthcare Products Regulatory Agency, and a member of the MedDRA Management Board
MSSO
Maintenance and Support Services Organisation, the repository, maintainer, and distributor of MedDRA
MedDRA
Medical Dictionary for Regulatory Activities Terminology; developed under the auspices of ICH and maintained by MSSO, and provides an international medical dictionary applicable to all phases of drug development
MedDRA Management Board
Is appointed by the ICH Steering Committee to oversee the activities of the "Maintenance and Support Services Organisation" (MSSO) for MedDRA, and ensure that the MSSO is meeting the various needs of MedDRA users. The Management Board is composed of one representative from each of the six ICH Parties and one representative from MHRA and Health Canada. The IFPMA acts as a non-voting observer on the Management Board, and chairs the Board
MedDRA Points to Consider Document (PtC)
Provides a best practice approach for the use of MedDRA
MedDRA Points to Consider Working Group
Works to develop best practice initiatives related to the use of MedDRA, and to maintain the released PtC documents in parallel with MedDRA version updates. To the MedDRA Points to Consider Working Group, each of the six official ICH parties nominates official representatives and, unless otherwise specified by the Steering Committee, the official membership is limited to two officials per party per working group and one representative per ICH Observer. Representatives from the MSSO and JMO are also members of this working group
Membership
(As applied to EWGs, IWGs, Informal WGs, Discussion Groups, Brainstorming Groups, and Pilot WG). Each of the six official ICH Parties nominates official representatives and, unless otherwise specified by the Steering Committee, the official membership is limited to two officials per party per working group and one representative per ICH Observers, and also if applicable, one per Interested Party
Options Paper
May be requested by the Steering Committee to outline the options in terms of the benefits, costs and risks of outsourcing specific tasks to organisations external to the ICH process i.e., consideration of the use of vocabulary services for the maintenance of complex terminology, or the use of SDOs (Standards Development Organisations) for the development of technical standards (M2 Message Standards)
PANDRH
Pan American Network on Drug Regulatory Harmonization, and one of the Regional Harmonisation Initiatives (RHIs)
PMDA
Pharmaceuticals and Medical Devices Agency (Japan)
PhRMA
Pharmaceutical Research and Manufacturers of America, and one of the six ICH Parties
Pilot Working Group
Is a group that works to test the initial viability of a business model or idea by carrying out Pilot Testing i.e., the Pilot Working Group for the Maintenance of ICH Controlled Terminology Lists carried out Pilot Testing to develop Standard Operating Procedures (SOPs) for the maintenance of terminology lists
RHI
Regional Harmonisation Initiatives founded on the principle of harmonising drug regulation across a defined group of non-ICH countries
Rapporteur
Is a representative of one of the six ICH parties, who is designated by the Steering Committee when a new topic is formally adopted. The Rapporteur is responsible for leading a working group (EWG/IWG) and ensuring that the group keeps an up-to-date action plan and timetable, with clear deliverables and deadlines. The Rapporteur shall regularly present reports to the Steering Committee, focusing in particular on the timelines and milestones
Recommendations Document
Due to the information technology (IT) nature of the M2 EWG's work on Electronic Standards for the Transfer of Regulatory Information (ESTRI), some of their activities result in Recommendations. These Recommendations do not undergo the ICH step process so as to allow for flexible change as both science, and technologies evolve. They are agreed in the EWG, signed by all parties of the EWG, and are approved and signed off by the ICH Steering Committee. Current M2 Recommendations are posted on the Electronic Standards
SADC
South African Development Community, and one of the Regional Harmonisation Initiatives (RHIs)
Step Process
Topic Leader / Deputy Topic Leader
Are the two officially nominated representatives that each of the six ICH parties will elect to represent their party in an EWG/IWG. It is the responsibility of the Topic Leader/Deputy Topic Leader to officially represent a consolidated view of their party during any ICH interaction