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 2

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 ⓘ
appliesToEntityType ICH Members ⓘ
ICH Observers ⓘ
ICH Working Group experts ⓘ
approvedBy ICH Assembly ⓘ
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 ⓘ
relatedTo ICH Articles of Association ⓘ
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 ⓘ
ICH Management Committee ⓘ
ICH Secretariat ⓘ
ICH Working Groups ⓘ

How these facts were elicited

Referenced by (2)

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

ICH Secretariat → follows → ICH Rules of Procedure ⓘ
ICH Articles of Association amendments → isRelatedTo → ICH Rules of Procedure ⓘ