India Specifies Requirements For Pharmacovigilance System Master File, Qualified Person
Executive Summary
The Indian government has borrowed some EU concepts while framing a pharmacovigilance guideline for marketing authorization holders. The guideline, effective January 2018, requires marketing authorization holders to maintain a pharmacovigilance system master file within India where the main pharmacovigilance activities take place, and to hire a pharmacovigilance qualified person to oversee the entire system.