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The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines. Since its inception in 1990, ICH has gradually evolved, to respond to increasingly global developments in the pharmaceutical sector and these ICH guidelines are applied by a growing number of regulatory authorities. ICH's mission is to achieve greater harmonisation worldwide to ensure that safe, effective and high quality medicines are developed, and registered and maintained in the most resource efficient manner whilst meeting high standards. Since its announcement of organisational changes in October 2015, ICH has grown as an organisation and now includes 23 Members and 38 Observers.

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ICH Assembly
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ICH Assembly
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The ICH Assembly met on 5 & 6 November 2024 in Montreal, Canada. For more information on the meeting, please see the Press Release.

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ICH New Observer
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ICH New Observer (CPPS, Ubekistan)
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ICH Assembly Chair and Vice-Chair with new ICH Observer CPPS, Uzbekistan at Montreal Meeting, November 2024.

Photo L to R: Ms. Lenita Lindström (Assembly Chair - EC, Europe); Mr. Alisher Temirov (CPPS, Uzbekistan); Dr. Gabriela Zenhäusen (Assembly Vice-Chair - Swissmedic, Switzerland)

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ICH New Observer
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ICH New Observer (DIGEMID, Peru)
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ICH Assembly Chair and Vice-Chair with new ICH Observer DIGEMID, Peru at Montreal Meeting, November 2024.

Photo L to R: Ms. Lenita Lindström (Assembly Chair - EC, Europe); Dr. Cory Montero Suyo (DIGEMID, Peru)); Dr. Gabriela Zenhäusen (Assembly Vice-Chair - Swissmedic, Switzerland)

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Discover ICH Products
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Quality Guidelines
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Quality Guidelines
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Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities... (more)

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Safety Guidelines
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Safety Guidelines
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ICH has produced a comprehensive set of safety guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity. A recent breakthrough has been a non-clinical testing strategy ... (more)

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Efficacy Guidelines
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Efficacy Guidelines
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The work carried out by ICH under the Efficacy heading is concerned with the design, conduct, safety and reporting of clinical trials. It also covers novel types of medicines... (more)

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Multidisciplinary Guidelines
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Multidisciplinary Guidelines
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Those are the cross-cutting topics which do not fit uniquely into one of the Quality, Safety and Efficacy categories.  It includes the ICH medical terminology (MedDRA)... (more)

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M4: CTD
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M4: CTD
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The agreement to assemble all the Q, S, and E information in a common format (called CTD - Common Technical Document) has revolutionized the regulatory review processes... (more)

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M1: MedDRA
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M1: Meddra
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MedDRA is a rich and highly specific standardised medical terminology developed by ICH to facilitate sharing of regulatory information internationally for medical products used by humans. ... (more)

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Upcoming Events
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ICH Guideline Database
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Search tools are available for easy retrieval of information on ICH Guidelines:

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Help to Shape the ICH Guidelines
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Your contribution will be considered by ICH for the documents currently under consultation available on this page.

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