has been to contribute to harmonised views of international systems and terminologies used for the safety surveillance of medicinal products and vaccines between stakeholders. It has therefore been crucial to invite all stakeholders; the independent status of CIOMS has permitted it to coordinate the contributions and expertise of senior scientists from research-based biopharmaceutical companies, national drug regulatory authorities, academia, and representative bodies of medical specialties to this harmonizing and strengthening of drug-safety surveillance measures. Scientists are invited based on their recognized specific expertise and, if required, in consultation with their background institution. Members and consulted experts and their affiliations are listed in the publications. The consensus reports and documents are discuss and recommend general principles without focusing on individual medicinal products. Areas covered include international reporting of adverse drug reactions (CIOMS I reporting form), management of safety data from clinical trials, periodic drug safety updates in the pre-and post-approval phases, core clinical safety information on drugs in development and also those available to patients and prescribers, Adverse Drug Reaction terminology, Standardized MedDRA® Queries (SMQs), drug development research issues, pharmacogenetics, pharmacovigilance in resource-limited countries and safety signal detection and management.
The International Council for Harmonisation (until 2015 International Conference on Harmonization of Technical Requirements for Pharmaceuticals for Human Use) or just “ICH”, is a unique arrangement bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. Since its inception in 1990 it has developed into most influential arrangement of producing regulatory guidelines, mostly for quality, safety and efficacy, which are implemented in the EU, Canada, Japan, Switzerland and United States.