ICH Articles of Association amendments
E555148
The ICH Articles of Association amendments are formal changes to the foundational governing document of the International Council for Harmonisation that define its structure, decision-making processes, and membership rules.
Statements (44)
| Predicate | Object |
|---|---|
| instanceOf |
governance document amendment
ⓘ
organizational legal instrument ⓘ |
| aimsTo |
clarify roles of regulatory and industry members in ICH
ⓘ
ensure transparency in ICH governance ⓘ support effective global harmonisation of pharmaceutical regulations ⓘ |
| appliesIn | international regulatory harmonisation context ⓘ |
| appliesTo | International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use NERFINISHED ⓘ |
| clarifies |
chairmanship and secretariat arrangements in ICH
ⓘ
conditions for accession of new ICH Members ⓘ conditions for suspension or termination of ICH membership ⓘ voting rights of different ICH membership categories ⓘ |
| concerns |
criteria for ICH membership categories
ⓘ
dispute resolution mechanisms within ICH ⓘ funding and financial provisions of ICH ⓘ intellectual property and use of ICH materials ⓘ liability and indemnification provisions within ICH ⓘ participation of Observers in ICH ⓘ procedures for adopting ICH guidelines ⓘ procedures for convening ICH meetings ⓘ procedures for further amendment of the ICH Articles of Association ⓘ quorum requirements for ICH decision-making ⓘ rights and obligations of ICH Members ⓘ roles and responsibilities of ICH governing bodies ⓘ structure of the ICH Association ⓘ voting procedures within ICH ⓘ |
| defines |
decision-making processes of the International Council for Harmonisation
ⓘ
governance structure of the International Council for Harmonisation ⓘ membership rules of the International Council for Harmonisation ⓘ |
| documentsIn | official ICH legal and governance records ⓘ |
| governs |
ICH Assembly structure
ⓘ
ICH Management Committee structure ⓘ relationship between ICH Association and its Members ⓘ |
| hasLegalForm | amendment to articles of association under Swiss law ⓘ |
| hasStakeholder |
observers and non-voting participants in ICH
ⓘ
pharmaceutical industry associations participating in ICH ⓘ regulatory authorities participating in ICH ⓘ |
| isPartOf | ICH governance framework NERFINISHED ⓘ |
| isRelatedTo |
ICH Guideline development process
ⓘ
ICH Rules of Procedure NERFINISHED ⓘ |
| language | English (authoritative version) ⓘ |
| relatesTo | ICH Articles of Association NERFINISHED ⓘ |
| requires |
compliance with applicable national and international laws
ⓘ
formal approval by ICH governing bodies ⓘ |
| supports | operation of the ICH as a legal association ⓘ |
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.