The International Council on Harmonization (ICH) is an organization that brings together regulatory authorities and pharmaceutical industry representatives from around the world to develop and implement harmonized guidelines and standards for drug development and regulatory approval. The goal of ICH is to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner.
Key ICH Guidelines:
- Efficacy: Guidelines on clinical trials and drug efficacy evaluation.
- Safety: Standards for drug safety assessments, including toxicology studies.
- Quality: Guidelines for the manufacturing and quality control of pharmaceuticals.
- Multidisciplinary: Covers topics such as electronic standards for the transfer of regulatory information (ESTRI).