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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