International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

E23680

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a global body that develops and promotes unified scientific and technical standards to ensure the safety, quality, and efficacy of medicines worldwide.


Statements (49)
Predicate Object
instanceOf international standards organization
nonprofit organization
abbreviation ICH
coordinatesWith World Health Organization
regional regulatory agencies
develops ICH guidelines
efficacy guidelines
multidisciplinary guidelines
quality guidelines
safety guidelines
field drug development
pharmaceutical regulation
regulatory science
focusesOn efficacy of medicines
multidisciplinary aspects of pharmaceutical regulation
quality of medicines
safety of medicines
formerName International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
founded 1990
goal facilitate timely access to new medicines for patients worldwide
promote more efficient development of safe and effective medicines
hasBody ICH Management Committee
ICH MedDRA Management Committee
ICH Secretariat
hasMemberType pharmaceutical industry associations
regulatory authorities
hasObserverType international organizations
regional harmonisation initiatives
hasWorkingLanguage English
headquartersLocation Geneva, Switzerland
mainOrgan ICH Assembly
notableWork ICH E2A Clinical Safety Data Management
ICH E6 Good Clinical Practice
ICH M4 Common Technical Document
ICH Q10 Pharmaceutical Quality System
ICH Q8 Pharmaceutical Development
ICH Q9 Quality Risk Management
ICH S7A Safety Pharmacology Studies for Human Pharmaceuticals
ICH S9 Nonclinical Evaluation for Anticancer Pharmaceuticals
purpose development of common guidelines for pharmaceutical quality, safety, and efficacy
facilitation of global drug registration
harmonisation of technical requirements for pharmaceuticals for human use
protection of public health through consistent standards for medicines
reduction of duplication in drug development and registration
regionServed global
shortName ICH
International Council for Harmonisation
standardizes technical requirements for registration of pharmaceuticals for human use
website https://www.ich.org

Referenced by (5)
Subject (surface form when different) Predicate
European Medicines Agency
cooperatesWith
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ("International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use")
formerName
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ("ICH MedDRA Management Committee")
hasBody
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ("ICH S7A Safety Pharmacology Studies for Human Pharmaceuticals")
notableWork
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ("International Council for Harmonisation")
shortName

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