Market Authorization Holders Commit to Strengthening Product Safety through Continuous Reporting
Addis Ababa, March 21, 2025 – Ethiopian Food and Drug Authority (EFDA) hosted an orientation workshop for Qualified Persons for Pharmacovigilance (QPPVs). The session brought together professionals from various Market Authorization Holders (MAHs) to discuss their crucial role in safety monitoring and Periodic Safety Update Report.
Opening the workshop, Asnakech Alemu, Lead Executive Officer of Pharmacovigilance and Clinical Trials, emphasized the importance of proactive pharmacovigilance. She noted that EFDA has developed a pharmacovigilance directive under the Food and Medicine Administration Proclamation No. 1112/2019, ensuring that MAHs take responsibility for safety monitoring and Periodic Safety Update Report in a timely manner.
“Ensuring the safety of pharmaceutical products is a shared responsibility,” Asnakech said. “QPPVs play a key role in protecting public health by detecting and reporting adverse drug event that may arise with medications.”
Demeke Amare, from EFDA’s Pharmacovigilance and Clinical Trials Lead Executive Office, led a detailed discussion on the duties and responsibilities of QPPVs. His presentation highlighted best practices for monitoring product safety and reinforced the regulatory obligations of market authorization holders.
Participants actively engaged in discussions, sharing experiences and challenges they face in pharmacovigilance. They expressed their commitment to improving reporting mechanisms and working closely with EFDA to ensure the continuous safety and quality of medicines available in Ethiopia.
