ICH Guidelines

ICH guidelines are a set of guidances to ensure safe, effective and high-quality medicines are developed and registered efficiently. These guidelines have been adopted by regulatory authorities throughout the world.

ICH quality guidelines Q1A(R2) through Q1E cover stability, and the related titles are “Stability Testing of New Drug Substances and Products,” “Stability Testing: Photostability Testing of New Drug Substances and Products,” “Stability Testing for New Dosage Forms,” “Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products,” and “Evaluation of Stability Data.”

ICH stands for The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Founded in 1990, it brings together the regulatory and pharma industry authorities. Together they create the ICH guidelines.

The Common Technical Document (CTD) is maintained by ICH. In the CTD, quality, safety and efficacy information are put together in a common format. The CTD enabled the implementation of good review practices. It makes the regulatory review process simple. With the CTD, reformatting information for different ICH regulatory authorities is a thing of the past. CTD has five modules. The first is region specific and the remaining four are meant to apply to all regions.

The U.S. Food and Drug Administration (FDA) is a founding member of ICH. Per the agency's website, they promote ICH requirements and their use by by pharma regulatory authorities around the globe. As a member, FDA can, among other things, endorse draft ICH guidelines.