Substandard and falsified medical products continue to pose a threat to lives across Africa. They undermine treatment outcomes, fuel antimicrobial resistance, and erode public confidence in health systems. These unsafe products also impose a heavy financial burden on countries, compromising progress toward universal health coverage. Addressing this urgent challenge requires stronger regulatory systems and coordinated continental action to ensure that every medicine reaching patients is safe, effective, and of high quality.
Substandard medical products are authorized medicines that fail to meet quality standards or specifications. They may contain the wrong amount of active ingredients, may be contaminated, or may degrade due to poor storage or handling. Falsified medical products are deliberately misrepresented in terms of their identity, composition, or source. They may carry false labeling, contain incorrect ingredients and/or have no label, or appear deceptively similar to genuine products. Substandard and falsified medicines represent a persistent public health threat that no single country can tackle alone.
Strengthening regulation through harmonization
The African Union Development Agency-NEPAD (AUDA-NEPAD) and PATH convened a capacity-building workshop in Addis Ababa, Ethiopia, under the African Medicines Regulatory Harmonization (AMRH) program to build that collective strength. The AMRH program, launched by AUDA-NEPAD in 2009, has become a cornerstone of Africa’s efforts to align regulatory processes, promote collaboration among National Medicine Regulatory Authorities, and accelerate access to quality-assured medical products.
The three-day workshop, a testament to our shared commitment, brought together regulators, policymakers, legal experts, civil society, and media representatives from Burkina Faso, Chad, Congo Brazzaville, the Democratic Republic of the Congo, Djibouti, Liberia, and Seychelles.
Through interactive presentations and group discussions and activities, participants examined how harmonized regulatory systems can improve efficiency, build mutual trust, and ensure that medical products approved in one country meet consistent standards across the region. Conversations also underscored how fragmented or under resourced systems create gaps that allow substandard and falsified medical products to enter African markets. Countries can strengthen oversight, enhance data sharing, and take coordinated action to safeguard public health by working toward harmonization.
“This workshop was designed to move conversations from policy to practice. Our goal is to strengthen the capacity of national regulators and advocates to influence change, so that every country, regardless of where it starts, can move confidently toward harmonized regulation and eliminate the threat of substandard and falsified medical products,” said Lindokuhle Dlamini, Policy Advocacy and Communications Officer at AUDA-NEPAD.
“Our goal is to strengthen the capacity of national regulators and advocates to influence change, so that every country, regardless of where it starts, can move confidently toward harmonized regulation...”— Lindokuhle Dlamini, Advocacy & Communications Officer, AUDA-NEPAD
The AU Model Law and AMA Treaty: Catalysts for change
At the heart of the discussions were two key continental frameworks: the African Union (AU) Model Law on Medical Products Regulation and the African Medicines Agency (AMA) Treaty. Together, they offer a blueprint for harmonization, helping countries establish clear, coherent, and mutually recognized regulatory systems.
The AU Model Law provides a foundation for countries to align national policies, improve market authorization procedures, and ensure that medical products meet consistent safety, efficacy, and quality standards. Once ratified and operationalized, the AMA Treaty enables countries to collaborate through a continental authority, coordinating joint reviews, strengthening post-market surveillance, and responding swiftly to emerging health threats.
These frameworks also support the National Action Plan to combat substandard and falsified medical products, reinforcing that regulatory reform is a continental priority rooted in public health and equity.
“The AU Model Law and AMA Treaty are not abstract policies; they are tools for protecting lives,” Dlamini emphasized. “When fully implemented, they help ensure that every medicine reaching patients in Africa is safe, effective, and of good quality.”
“The AU Model Law and AMA Treaty are not abstract policies; they are tools for protecting lives. When fully implemented, they help ensure that every medicine reaching patients in Africa is safe, effective, and of good quality.”— Lindokuhle Dlamini, Advocacy & Communications Officer, AUDA-NEPAD
Advocacy: Driving action and sustaining progress
Beyond technical reform, the workshop highlighted advocacy as the bridge between policy frameworks and country-level implementation. Guided by PATH’s 10-part framework for advocacy strategy development, participants developed practical advocacy action plans tailored to their national contexts.
Through interactive exercises, they identified key decision-makers, refined their policy messages, and mapped opportunities to strengthen political and financial support for regulatory reform. Participants also explored how advocacy can mobilize media and civil society to raise awareness about the dangers of substandard and falsified medical products and the importance of harmonized regulation.
“Advocacy capacity is the missing link between technical frameworks and real reform,” Dlamini noted. “When national regulators can effectively communicate the urgency of this issue, they are more likely to secure the political will and resources needed to act.”
Collective action for a safer health future
As more Member States domesticate the AU Model Law, ratify the AMA Treaty, and implement measures to eliminate substandard and falsified medical products, Africa moves toward a future where every patient can access safe, effective, and affordable medical products, no matter where they live.
The Addis Ababa workshop reflects AUDA-NEPAD and PATH’s ongoing partnership to strengthen Africa’s regulatory ecosystem through the AMRH program. By combining technical expertise, policy dialogue, and advocacy training, the collaboration equips countries to translate regional commitments into national action.
