ICH Guidelines News

Public Consultations on Drug Development Guidelines

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is seeking public input on proposed guidelines related to drug development standards. This consultation aims to gather feedback on new and revised guidelines before their finalization.

ICH Guidelines Overview

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) provides guidelines across quality, safety, efficacy, and multidisciplinary areas. These guidelines aim to harmonize technical requirements for pharmaceutical registration globally.

ICH Q1A(R2) Stability Testing Guideline Finalized

The International Council for Harmonisation (ICH) has finalized its Q1A(R2) guideline on stability testing of new drug substances and products. This revised guideline, effective February 6, 2003, provides updated recommendations for stability testing protocols across different climatic zones.