ICH Rules of Procedure

E555152

The ICH Rules of Procedure are the formal governance framework that defines how the International Council for Harmonisation (ICH) conducts its operations, decision-making processes, and administrative activities.

All labels observed (1)

Label Occurrences
ICH Rules of Procedure canonical 1

How this entity was disambiguated

Statements (48)

Predicate Object
instanceOf formal procedural document
governance framework
organizational rules of procedure
appliesInDomain international health regulation collaboration
pharmaceutical regulatory harmonisation
appliesTo International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use NERFINISHED
appliesToEntityType ICH Members NERFINISHED
ICH Observers
ICH Working Group experts
approvedBy ICH Assembly NERFINISHED
characteristic binding on ICH participants
formal
written
defines procedures for ICH decision making
procedures for ICH document adoption
procedures for ICH meetings
procedures for ICH membership and observership
procedures for amendment of the Rules of Procedure themselves
procedures for chairing ICH meetings
procedures for conflict of interest management within ICH
procedures for decision recording and minutes approval in ICH
procedures for documentation and record keeping within ICH
procedures for establishing agendas for ICH meetings
procedures for secretariat support to ICH bodies
procedures for transparency and publication of ICH outputs
processes for adopting new ICH topics
processes for establishing ICH working groups
processes for revising ICH guidelines
quorum requirements for ICH decision making
roles and responsibilities of ICH bodies
voting rules within ICH governing bodies
governs administrative activities of the International Council for Harmonisation
decision-making processes of the International Council for Harmonisation
operations of the International Council for Harmonisation
hasPurpose to ensure consistency and transparency in ICH operations
to provide a formal governance framework for ICH
to structure the harmonisation work of ICH
language English
maintainedBy ICH Secretariat NERFINISHED
relatedTo ICH Articles of Association NERFINISHED
ICH governance documents
scope governance of ICH structures and processes
procedural aspects of ICH guideline development
procedural aspects of ICH membership and participation
usedBy ICH Assembly NERFINISHED
ICH Management Committee NERFINISHED
ICH Secretariat NERFINISHED
ICH Working Groups NERFINISHED

How these facts were elicited

Referenced by (1)

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

ICH Secretariat follows ICH Rules of Procedure