The International Council for Harmonisation (ICH) is unique in bringing together regulatory authorities and the pharmaceutical industry to harmonise scientific and technical requirements for the safety, efficacy and quality of medicines for human use.
ICH convenes the world’s top experts in their fields to produce harmonised guidelines that are seen as global standards for medicine safety, efficacy and quality during development and manufacture.
ICH guidelines are developed through a process of scientific consensus involving experts from around the world, with extensive public and regulatory consultation. The final harmonised guidelines are approved and adopted by ICH member regulatory authorities and published on the ICH website.
The harmonised guidelines are embedded in national and regional regulatory frameworks around the world. They support more consistent and streamlined submissions by industry, and more timely and coherent assessments by regulatory authorities, contributing to the rapid availability of safe, effective and high-quality medicines for patients. In turn, global harmonisation and regulatory coherence support therapeutic innovation.
ICH is a non-profit association registered in Switzerland.
The ICH vision is of a world where all patients benefit from safe, effective and high-quality medicines and timely treatment innovations that meet harmonised, science-based requirements to protect and advance public health.
Started in 1990 by regulatory agencies and industry associations of Europe, Japan and the US, ICH was registered as a Swiss non-profit association in 2015. It has continued to grow and now represents pharmaceutical regulators and industry from six continents.
ICH is committed to making its work transparent. This means sharing processes, procedures, meeting outcomes, key documents and the real-time progress of ICH guideline development. Meeting minutes, work plans and much more are published on the ICH website, and draft guidelines are posted for public consultation.
The ICH Association is primarily funded by annual membership fees. The ICH Assembly approves the Association’s annual budget, membership fees and any other sources of funding.
Annual work plans and multi-year overviews, including of ICH harmonisation activities, are updated and published annually, along with the ICH Association’s annual report.
ICH membership provides a direct voice in the development and implementation of impactful, harmonised, international pharmaceutical guidelines, and access to an engaged global network of regulators and industry experts.
To support its mission of global harmonisation, ICH works with a select number of organisations that share common interests in pharmaceutical regulation, guideline implementation, training and international outreach.
The ICH Award for Outstanding Contributions to Harmonisation for Better Health recognises scientific and technical experts who have played important and sustained leadership roles in ICH working groups.
At ICH, you have the opportunity to contribute to an important and influential global initiative in pharmaceutical regulation that is more than 35 years old.