30-06-2018, Addis Ababa (Ethiopia): Experts and officials in charge of pharmaco-vigilance and post-marketing surveillance from Member States of the Intergovernmental Authority on Development (IGAD) yesterday closed a five-day long working group meeting.
This working group with technical assistance from Promoting the Quality of Medicines (PQM) program, which is financed by the U.S. Agency for International Development and implemented by the United States Pharmacopeia, produced recommendations for a regional cross-border pharmacovigilance system and for the implementation of a regional post-marketing surveillance strategy and related guidelines.
A regional protocol for studying the prevalence of substandard and falsified medicines at selected IGAD cross-border sites, targeting products used in maternal & child health, family planning, tuberculosis, and HIV & AIDS programs was also drafted.
Another achievement of the working group was the finalization of a draft Terms of Reference for their role and responsibilities on Pharmacovigilnace and Post-Marketing Surveillance.
Participants from Member States expressed their satisfaction over the establishment of their working group and substance into the programme of the meeting. They highlighted the need for all Member States to be brought to the same level in subject matters and expressed to desire to exchange more.
Furthermore, the meeting had the following deliverables:
- The meeting established an expert technical working group for Pharmacovigilance and Post-Marketing Surveillance;
- The draft protocol for quality survey of Oxytocin Injection at cross border sites was reviewed and will be finalized by member states;
- The provided a roadmap and recommendations on how the region would collaborate in Pharmacovigilance and Post-Marketing Surveillance. I have attached the recommendations for your review.