The mission of the ICH is to promote public health by achieving greater harmonisation through the development of technical guidelines and requirements for pharmaceutical product registration.
[1] Harmonisation leads to a more rational use of human, animal and other resources, the elimination of unnecessary delay in the global development, and availability of new medicines while maintaining safeguards on quality, safety, efficacy, and regulatory obligations to protect public health.
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.
[citation needed] In 2015, ICH underwent several reforms and changed its name to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use while becoming a legal entity in Switzerland as a non-profit association.
[4][5] The aim of these reforms was to transform ICH into a truly global initiative supported by a robust and transparent governance structure.
[6] The ICH association established an assembly as the over-arching governing body with the aim of focusing global pharmaceutical regulatory harmonisation work in one venue that allows pharmaceutical regulatory authorities and concerned industry organisations to be more actively involved in ICH's harmonisation work.
The development of a new harmonised guideline and its implementation (the formal ICH procedure) involves 5 steps:[9] The WG works to prepare a consensus draft of the technical document, based on the objectives set out in the concept paper.
The ICH harmonised guideline moves immediately to the final step of the process that is the regulatory implementation.