ICH Assembly

E131964

The ICH Assembly is the primary decision-making and governance body of the International Council for Harmonisation, bringing together regulatory authorities and industry to adopt harmonised pharmaceutical guidelines.

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Label Occurrences
ICH Assembly canonical 3

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Statements (46)

Predicate Object
instanceOf decision-making body
governing body
organ of the International Council for Harmonisation
aim facilitate global development and registration of medicines
promote public health through harmonised pharmaceutical regulation
reduce duplication of clinical trials and regulatory submissions
collaboratesWith international pharmaceutical industry associations
national regulatory authorities
regional regulatory agencies
composedOf industry members
industry observers
regulatory members
regulatory observers
standing observers
decisionMakingMode consensus-based
governanceStructureElement Chair
Secretariat
Vice-Chair
governs harmonisation of technical requirements for pharmaceuticals for human use
hasAuthorityOver ICH Management Committee
ICH Working Groups
hasMemberType pharmaceutical industry association
regulatory authority
language English
locationOfMeetings various international locations
meetingFrequency at least once per year
meets regularly
parentOrganization International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
surface form: International Council for Harmonisation
partOf International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
responsibleFor ICH Articles of Association amendments
ICH procedural and governance rules
adoption of new ICH guidelines
revision of existing ICH guidelines
role admits new ICH members and observers
adopts harmonised pharmaceutical guidelines
approves ICH work plans and strategic priorities
approves establishment of ICH Working Groups
governance body of ICH
oversees ICH guideline development and maintenance
oversees implementation of ICH reforms and procedures
primary decision-making body of ICH
scope global pharmaceutical regulatory harmonisation
quality, safety, efficacy and multidisciplinary guidelines
shortName ICH Assembly self-link
usesInstrument ICH guidelines
website https://www.ich.org

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Referenced by (3)

Full triples — surface form annotated when it differs from this entity's canonical label.