NAFDAC tasks stakeholders on medicine-surveillance

National Agency for Food and Drug Administration and Control (NAFDAC) has counselled stakeholders on the need to monitor medicines and medical devices after authorisation has been granted for their sale in the country.

Acting director general of the agency, Mrs. Yetunde Oni, made the call yesterday at a workshop on post-marketing surveillance in Abuja.
Post Marketing Surveillance (PMS) is the practice of monitoring the safety and quality of medicines or medical devices after they have been granted marketing authorisation.
Oni said PMS is important because some rare adverse events which were not discovered during the clinical trials could be identified once the products are widely used and monitored during post marketing surveillance.
“PMS is critical because limitation of phase 3 clinical trials where limited numbers of patients are used to monitor the medicine use over a short period of time, and some certain groups such as pregnant women, children and the elderly who would use those products when granted approval are often not included in such trials ,” Oni said.
The NAFDAC boss said the agency established its Pharmaco-vigilance Directorate to effectively monitor medicines in order to ensure that safe and quality products are consistently produced and sold in Nigeria.
She added that the workshop was aimed at identifying gaps and brainstorming on ways to strengthen PMS.