Safety requirements for the use of drugs
This program was initiated in the early 1980s in the light of the benefits that society as a whole derives from modern drugs and vaccines. At the same time, society must be prepared to accept the possibility of remote risks to the individual as the corollary of modern medical care and further therapeutic progress; without this realization, the basis of contemporary drug development will ultimately founder. Moreover, society must be assured that a responsible and committed effort is undertaken to minimize drug-induced injury, and that the risks of such injury compare favorably to those accepted in other aspects of daily life.
Assessment and monitoring of adverse drug reactions and pharmacogenetics
Eight CIOMS working groups have proposed recommendations within areas such as international reporting of adverse drug reactions -including the introduction of the standardized "CIOMS I reporting form", international reporting of periodic drug-safety updates, core clinical safety information on drugs, evaluation of benefit/risk balance, current challenges of pharmacovigilance, management of safety information from clinical trials and development safety update report (DSUR)and signal detection in pharmacovigilance. Seven of these are previously published and the outcome of Working Group VIII on signal detection is presently being published (for more detailed description of the Working groups see under the heading of "Working groups" and "Publications".
In addition there are Working Groups dedicated to pharmacogenetics, standardised MedDRA Queries (SMQs), reporting and terminology of adverse drug reactions and two joint CIOMS-WHO Working Groups); vaccine pharmacovigilance, drug development research and pharmacovigilance in resource-poor countries.