International Conference on Harmonisation (ICH) Guidelines

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration.

The ICH Guidelines are divided into four major categories and ICH Topic Codes are assigned according to these categories. Q: "Quality" Topics, S: "Safety" Topics, E: "Efficacy" Topics, M: "Multidisciplinary" Topics.

ICH Homepage