A

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)

B

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

C

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

D

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

E

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, the European Medicines Agency 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

F

FDA

US Food and Drug Administration, and one of the six ICH Parties

G

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

H

Health Canada

Health Canada is the Canadian Federal department for health, and one of the ICH Observers

I

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

J

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

M

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

O

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)

P

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

R

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

S

SADC

South African Development Community, and one of the Regional Harmonisation Initiatives (RHIs)

Step Process

The formal ICH procedure consists of 5 Steps: Step 1: Consensus Building, Step 2: Confirmation of six-party consensus, Step 3: Regulatory Consultation and Discussion, Step 4: Adoption of an ICH Harmonised Tripartite Guideline, Step 5: Implementation

T

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

W

WHO

World Health Organization, and one of the ICH Observers

WSMI

World Self-Medication Industry, and one of the ICH Interested Parties