News15.10.2025

πŸ“’ Final Reminder from Ethiopian Food and Drug Authority (EFDA) πŸ“’

πŸ“’ Final Reminder from Ethiopian Food and Drug Authority (EFDA) πŸ“’

The EFDA has issued its final reminder to all Marketing Authorization Holders (MAHs): it’s time to appoint a Local Qualified Person for Pharmacovigilance (QPPV) based in Ethiopia.

Under Proclamation No. 1112/2019 and the Pharmacovigilance Directive No. 932/2022, every MAH must have a pharmacovigilance system in place and notify EFDA of their Local QPPV, including their name, qualifications, and contact details, by October 31, 2025.

This notice underscores EFDA’s commitment to strengthening pharmacovigilance systems, ensuring regulatory compliance, and supporting the implementation of the Good Pharmacovigilance Practice (GVP) Inspection Guideline, which came into effect in April 2025.

πŸ“… Deadline: October 31, 2025
🏒 Who’s affected: All MAHs operating in Ethiopia
πŸ“ What to do: Appoint and notify EFDA of your Local QPPV

#drugsafety #pharmacovigilance #EFDA