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WELCOME TO THE ICH OFFICIAL WEBSITE



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 18 Members and 33 Observers.




SHARING OF ICH PERSPECTIVES



With ICH commemorating its 30th Anniversary in 2020, ICH is pleased to release a
video in which ICH Members and Observers look back at ICH’s evolution since its
inception in 1990, reflect on the positive impact of ICH for public health and
share considerations on future directions.





Previous


ICH MC CHAIR AND VICE CHAIR



Dr. Theresa Mullin (FDA, United States) and Dr. Nobumasa Nakashima (MHLW/PMDA,
Japan) were re-elected by the ICH Management Committee as Chair and Vice Chair
respectively to serve a one-year term.



2020 marks ICH’s 30th Anniversary. Since its inception in 1990, ICH has
gradually evolved, to respond to increasingly global developments in the
pharmaceutical sector and the ICH Guidelines are applied by a growing number of
regulatory authorities.




ICH ASSEMBLY



The ICH Assembly met in Singapore on 19 & 20 November 2019.

For more information on the meeting, see the ICH Press Release.




MEDDRA MANAGEMENT COMMITTEE



The MedDRA Management Committee met in Singapore on 17 & 18 November 2019.

For more information on the meeting, see the ICH Press Release.




ICH ASSEMBLY CHAIR AND VICE CHAIR



Ms. Lenita Lindström-Gommers (EC, Europe) and Dr. Celia Lourenco (Health Canada,
Canada) were re-elected by the Assembly as its Chair and Vice Chair respectively
to serve a two-year term.




ICH MC CHAIR AND VICE CHAIR



Dr. Theresa Mullin (FDA, United States) and Dr. Nobumasa Nakashima (MHLW/PMDA,
Japan) were re-elected by the ICH Management Committee as Chair and Vice Chair
respectively to serve a one-year term.



2020 marks ICH’s 30th Anniversary. Since its inception in 1990, ICH has
gradually evolved, to respond to increasingly global developments in the
pharmaceutical sector and the ICH Guidelines are applied by a growing number of
regulatory authorities.




ICH ASSEMBLY



The ICH Assembly met in Singapore on 19 & 20 November 2019.

For more information on the meeting, see the ICH Press Release.




MEDDRA MANAGEMENT COMMITTEE



The MedDRA Management Committee met in Singapore on 17 & 18 November 2019.

For more information on the meeting, see the ICH Press Release.




ICH ASSEMBLY CHAIR AND VICE CHAIR



Ms. Lenita Lindström-Gommers (EC, Europe) and Dr. Celia Lourenco (Health Canada,
Canada) were re-elected by the Assembly as its Chair and Vice Chair respectively
to serve a two-year term.




ICH MC CHAIR AND VICE CHAIR



Dr. Theresa Mullin (FDA, United States) and Dr. Nobumasa Nakashima (MHLW/PMDA,
Japan) were re-elected by the ICH Management Committee as Chair and Vice Chair
respectively to serve a one-year term.



Next


DISCOVER ICH PRODUCTS

Previous


M1: MEDDRA



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)




QUALITY GUIDELINES



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




SAFETY GUIDELINES



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)




EFFICACY GUIDELINES



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)




MULTIDISCIPLINARY GUIDELINES



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)




M4: CTD



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)




M1: MEDDRA



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)




QUALITY GUIDELINES



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




SAFETY GUIDELINES



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)




EFFICACY GUIDELINES



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)




MULTIDISCIPLINARY GUIDELINES



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)




M4: CTD



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)




M1: MEDDRA



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)



Next


UPCOMING EVENTS




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ICH GUIDELINE DATABASE



Search tools are available for easy retrieval of information on ICH Guidelines:

 * Index of ICH Guidelines by keyword, status and date
 * Status of Implementation of ICH Guidelines by ICH Members




HELP TO SHAPE THE ICH GUIDELINES



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




RECENT NEWS

19 October 2021

ICH 30th Anniversary Publication – ICH - the global platform for harmonisation

ICH is pleased to announce the publication of a 30th Anniversary document. This
follows ICH’s 2020 celebration of 30 years of harmonisation activity.

15 October 2021

ICH E6(R3) EWG Update on Progress Public Web Conference Report and Video
Presentation Online

The ICH Secretariat is pleased to announce that following the conclusion of the
ICH E6(R3) EWG’s Public Web Conference on Good Clinical Practice in May 2021, a
Report is available to download and a Video Presentation has been published on
the ICH YouTube channel.

6 October 2021

The ICH E8(R1) Guideline reaches Step 4 of the ICH Process

This modernisation of ICH E8 is the first step towards the Renovation of Good
Clinical Practice initiated in 2017. The revision incorporates the most current
concepts achieving fit-for-purpose data quality as one of the essential
considerations for all clinical trials. 

See all news
   
 * About ICH
     
     
   * Mission
   * History
   * Transparency
   * Funding
   * Work with ICH
     
     
   * Organisational Chart
   * Members & Observers
   * Value of Membership
   * Application Process
     
     
   * Articles & Procedures
   * Work Plans & Reports
     
 * Work Products
     
     
   * Process of Harmonisation
   * Public Consultations
   * Guideline Implementation
     
     
   * All Guidelines
   * Quality Guidelines
   * Safety Guidelines
   * Efficacy Guidelines
   * Multidisciplinary Guidelines
   * Index of Guidelines
     
     
   * MedDRA
   * CTD
   * Electronic Standards (ESTRI)
     
     
   * Reflection Papers
   * Consideration Documents
     
 * Meetings
     
     
   * ICH Calendar
   * Assembly
   * Management Committee
     
     
   * ICH Public Events
     
 * Training
 * Newsroom
     
     
   * News
   * Publications
   * Press Releases
     
   
 * See also
     
   * Contact

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