Working to ensure that people across Africa have access to state-of-the-art medical products and technology, stakeholders gathered in Accra, Ghana, in November at the 3rd Biennial Scientific Conference on Medical Products Regulation in Africa to discuss efforts to harmonize regulatory standards and explore how this important work can maintain its momentum. Countries throughout Africa are working to harmonize standards to make processes more efficient and help bring needed pharmaceuticals to market while protecting medicines quality.
The event brought together regulators, pharmaceutical manufacturers, pharmaceutical associations, technical partners, academia, the World Health Organization, and donors. Work of the Promoting the Quality of Medicines (PQM) program, funded by USAID and implemented by USP, featured prominently at the event, especially as it relates to our work with partners to foster harmonization efforts that will benefit people in Africa.
Kwasi Poku Boateng, Country Manager of USP-Ghana, shared updates about the Network of Official Medicines Control Laboratories (NOMCoL) in Africa, which is strengthening quality control and regulatory capacity in Africa. NOMCoL-Africa was established in 2009 by PQM, to facilitate south-south collaboration between Official Medicines Control Laboratories and share best practices across the region. Today, NOMCoL-Africa is transitioning to the African Medicines Quality Forum (AMQF) and expanding its focus to align with the African Union’s New Partnership for Africa’s Development – African Medicines Regulatory Harmonization’s (NEPAD-AMRH) programs for harmonization and medical product regulations initiative. This move marks a major milestone as this program transitions to African leadership.
AMQF’s focus will include:
- Advocacy and communication
- Laboratory proficiency testing
- Capacity building
- Regional post-market surveillance
- Bio-analytical testing for bioequivalence studies for generic medicines
- Certification planning for quality control analysts and laboratories
Abdelkrim Smine, Regional Director of Global Public Health - Africa, and Farouk Adams Umaru, PQM Principal Technical Manager, presented PQM’s new risk-based approach to post-marketing surveillance, which helps regulators develop efficient and cost effective risk-based sampling and testing protocols. PQM works with regulators to tailor the risk-based approach to country’s objectives, needs and conditions. This approach is based on more than eight years of experience collaborating with regulators and other local stakeholders in monitoring medicines quality in more than 30 countries across Asia, Africa and Latin America.