History of International Council for Harmonisation (ICH)
ICH Official Website
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) was established to address the need for harmonization in the evaluation and regulation of medicinal products. The realization of the importance of independent product evaluation emerged at different times globally and was often driven by tragic incidents like the thalidomide case in Europe in the 1960s. As the industry expanded internationally, varying technical requirements in different countries led to duplicative and costly procedures to market products globally. This highlighted the urgent need for rationalizing and harmonizing regulations to reduce healthcare costs, streamline R&D expenses, and meet public demands for timely access to safe treatments.
The initiation of ICH in the 1980s by the European Commission set the stage for harmonization efforts. Discussions among Europe, Japan, and the US on regulatory harmonization led to the formation of ICH at the World Health Organization Conference of Drug Regulatory Authorities in 1989. The collaboration between regulatory authorities and industry stakeholders culminated in ICH’s establishment in 1990 to focus on harmonizing safety, quality, and efficacy standards for new medicines. Over the years, ICH has evolved, developing guidelines on various topics, such as MedDRA and the Common Technical Document, to streamline regulatory processes across regions.
As ICH enters its fourth decade, the focus has shifted to extending harmonization benefits globally. Organizational reforms in 2015 aimed to increase international outreach, enhance governance structures, and disseminate information to a wider stakeholder audience. These changes have solidified ICH as a legal entity, fostering stable operations and enabling greater industry and regulatory participation. The establishment of the ICH Association with an Assembly as the governing body underscores the commitment to advancing global pharmaceutical regulatory harmonization efforts in a collaborative environment.
