A review on ICH Guidelines
Keywords:
ICH, Good clinical practices guidelines, Quality, Safety, Efficacy, Multidisciplinary, Pharmaceutical development, Quality by design, Real time release, Control strategy.Abstract
This article discusses the development of global guidance for registering technical dossiers for medicinal product applications. It highlights the relevance of NMR spectroscopy in drug development and control. The pharmaceutical industry's globalization has led to efforts to harmonize registration requirements across different regions, reducing costs while ensuring safe and effective medications. In the 1980s, discussions on harmonization began between Europe, Japan, and the United States, resulting in the establishment of the International Conference on Harmonisation (ICH) in 1991. ICH is a tripartite body consisting of regulators and industry representatives from the US, EU, and Japan. The ICH Steering Committee, supported by the IFPMA, identifies, and develops harmonized guidelines in areas such as efficacy, safety, quality, and multidisciplinary topics. More information can be found on the ICH website.
