Abstract
The International Council for Harmonisation (ICH) is a regulatory requirement to confirm the quality, safety, and efficacy (QSE) of drugs. It is an exceptional commission, which brings a union of drug regulatory experts and the pharma business partners from a few countries, such as the European Union, Japan, and the United States, for harmonization of the technical requirements for use of drugs in humans. The requirement of ICH is for several scientific and technical exchange negotiations related to testing procedures and for ensuring QSE of the drugs. The ICH offers numerous guidelines that exist under the categories of quality, safety, efficacy, and multidisciplinary guidelines. These guidelines contribute to distinct role in cases of patient population, large-scale human clinical trials, etc. The ICH guidelines related to the QSE and multidisciplinary aspects along with those on stability testing of new formulations and dosage forms are discussed in this chapter.
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