EVIX-PV/PMS -Postmarketing Surveillance (PMS) Service

On December 16th, 2019, MFDS announced a revision of its ?Guideline on Re-Examination on Affairs of New Drugs, etc.?

In this revised guideline, “database studies” were officially added as a mean of postmarketing surveillance and is defined as studies using medical information databases, i.e. patient medical records, health insurance claims data, patient registration system and other data on patient health status collected over a period of time and systematically computerized. As per the new guideline, database studies may be conducted to detect or identify drug adverse events and information on drug effectiveness and safety.