What is Pharmacovigilance?

What is Pharmacovigilance aka Drug Safety?

Yeah, that is not in the dictionary.  Pharmacovigilance (PV) means, Medicine(s) to watch out. Per World Health Organization, it is “The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problems.”

Why do Pharmaceutical companies do that ?

As per  21 CFR314.80 (K) Post-Approval Withdrawal of NDA,

“If an applicant fails to establish and maintain records and make  reports required under this section, regulators may withdraw approval of the application and, thus, prohibit continued marketing of the drug product that is the subject of the application.”

Fact: Read about  “Rofecoxib (Vioxx) voluntarily withdrawn from market”.