Post Marketing Safety (PMS) Reporting

Post marketing ICSR management is the practice of monitoring the safety of a pharmaceutical drug, vaccine or medical device after it has been released on the market and is an important part of the science of pharmacovigilance. Since drugs and medical devices are approved on the basis of clinical trials, which involve relatively small numbers of people who have been selected for this purpose-meaning that they normally do not have other medical conditions which may exist in the general population.

Post marketing surveillance (PMS) can further refine, or confirm or deny, the safety of a drug or device after it is used in the general population by large numbers of people who have a wide variety of medical conditions.

The type of ICSRs involved in PMS are Solicited cases (cases from organized data collection systems like patient support/operational program, patient assistance program, named patient use/compassionate use, market research survey, and cases from specialty pharmacies etc), spontaneous cases inclusive of literature cases and legal cases, cases from regulatory authorities, and license/business partners.


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