ICH: The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

[Audio] ICH: The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ICH Guidelines are adopted by regulatory authorities and published on the ICH website. The ICH topics are divided into the four categories..

[Audio] Quality Guidelines Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice risk management..

[Audio] Safety Guidelines ICH has produced a comprehensive set of safety Guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity..

[Audio] Efficacy Guidelines The work carried out by ICH under the Efficacy heading is concerned with the design, conduct, safety and reporting of clinical trials. It also covers novel types of medicines derived from biotechnological processes and the use of pharmacogenetics/genomics techniques to produce better targeted medicines..

[Audio] Multidisciplinary Guidelines Those are the cross-cutting topics which do not fit uniquely into one of the Quality, Safety and Efficacy categories. It includes the ICH medical terminology (MedDRA), the Common Technical Document (CTD) and the development of Electronic Standards for the Transfer of Regulatory Information (ESTRI)..