Pharmacovigilance Is at a Crossroads

The boundaries of medicine are rapidly changing. From gene editing to xenotransplantation, innovation is rapidly changing patient care as well as the requirements for drug safety, known as pharmacovigilance. Traditionally, pharmacovigilance has been directed towards the surveillance of drugs after they have been licensed for use. Going forward these rules will have to change.

This article was written by Ravi Patel, Senior Vice President, Global Patient Safety at United Therapeutics Corp and Anna Melin of Sidley and was originally published in MedNous (Managing European Medical Innovation), Vol 19, No 5, May 2025.