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.

All labels observed (1)

Label Occurrences
ICH Assembly canonical 12

How this entity was disambiguated

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 ⓘ
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 ⓘ
usesInstrument ICH guidelines ⓘ
website https://www.ich.org ⓘ

How these facts were elicited

Referenced by (12)

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

ICH Assembly → shortName → ICH Assembly ⓘ
ICH Secretariat → reportsTo → ICH Assembly ⓘ
ICH Working Groups → operatedBy → ICH Assembly ⓘ
ICH Working Groups → reportsTo → ICH Assembly ⓘ
ICH Secretariat → supports → ICH Assembly ⓘ
subject linked to: Secretariat
ICH Secretariat → serves → ICH Assembly ⓘ
subject linked to: Secretariat
ICH Secretariat → reportsTo → ICH Assembly ⓘ
subject linked to: Secretariat
ICH Executive Director → reportsTo → ICH Assembly ⓘ
ICH Rules of Procedure → usedBy → ICH Assembly ⓘ
ICH Rules of Procedure → approvedBy → ICH Assembly ⓘ