The agreement establishes a framework for cooperation between the African Medicines Agency (AMA) and the U.S. Pharmacopeia to strengthen regulatory systems, enhance capacity building, and improve access to quality-assured medical products across Africa.
29 April 2026 – Johannesburg - Yesterday, the AMA and USP signed a Memorandum of Understanding (MoU). The agreement formalizes the intent of both organizations to collaborate, within the framework of AMA’s continental mandate, on regulatory science, pharmacopeial standards, capacity building, and the promotion of access to quality-assured medical products across the African continent.
"AMA welcomes this partnership with USP. As we work to strengthen national regulatory authorities, advance regulatory harmonization, combat substandard and falsified medicines, and support local manufacturing, partnerships of this nature are critical.
USP's expertise in pharmacopeial standards, quality assurance and regulatory capacity building will support AMA’s efforts to ensure that these capabilities are aligned, connected, and applied consistently across countries.
This collaboration will strengthen our ability to translate Africa's health security ambitions into coordinated regulatory systems that deliver real impact — for regulators, for industry, and most importantly, for patients across Africa,” said Dr Delese Mimi Darko, Director-General, African Medicines Agency.
Under this collaboration, AMA and USP intend to cooperate across several priority areas, including advancing harmonized regulatory approaches under AMA; strengthening product quality monitoring and post-market surveillance systems; and capacity building and technical support aligned with AMA priorities.
“USP is pleased to partner with the African Medicines Agency at this pivotal moment for Africa’s health regulatory landscape. This MoU reflects our shared commitment to strengthening regulatory and quality systems, advancing regulatory harmonization, and improving access to safe, quality-assured medical products across the continent. We commend AMA’s leadership and look forward to working within its framework to apply science-based, fit-for-purpose approaches that translate this collaboration into practical programs with measurable, long-term impact for patients across Africa,” said Anthony Lakavage, JD, Executive Vice President, Secretary, USP Convention. The collaboration is reflective of the USP Convention’s Resolution to leverage USP programs and expertise to help strengthen regulatory systems around the world.
The MoU signing took place in Johannesburg, South Africa on the margins of the 3rd Africa Regional Chapter meeting of the USP Convention, convened under the theme “Partnering for Progress: Localization and Building Regulatory Capacity for Biologics and Advanced Therapies in Africa.”
The meeting brought together national regulatory authorities, industry representatives, and international partners to advance coordinated action on combating substandard and falsified medical products, supporting local manufacturing, and strengthening regulatory capacity for biologics and biosimilars.
Implementation of the MoU will be guided by mutually agreed work plans, with both organizations committing to establish a technical working group to support delivery under AMA’s coordination framework.
Notes to Editors
The African Medicines Agency (AMA) is a specialized Agency of the African Union, established under the Treaty for the Establishment of the African Medicines Agency, adopted in 2019 and entered into force in 2021. Headquartered in Kigali, Republic of Rwanda, AMA started its operations in October 2025.
AMA is mandated to enhance regulatory harmonization, strengthen national regulatory authorities and improve access to quality, safe and efficacious medical products across the African continent.
USP is a private, non-profit scientific organization that collaborates with stakeholders around the world to develop public quality standards and solutions that support quality across the development, manufacturing, and delivery of regulated health products; strengthen regulatory systems; enhance supply reliability; and support the adoption of innovation. Used in more than 150 countries, USP standards and solutions play a critical role in increasing the availability of quality medicines, dietary supplements, and food ingredients worldwide.
Media Contacts
AMA : Kakazi Kacyira – Communications Officer kakazik@au-ama.africa
USP : Carol McKay – Sr. Communications Manager mediarelations@usp.org
"AMA welcomes this partnership with USP. As we work to strengthen national regulatory authorities, advance regulatory harmonization, combat substandard and falsified medicines, and support local manufacturing, partnerships of this nature are critical.
USP's expertise in pharmacopeial standards, quality assurance and regulatory capacity building will support AMA’s efforts to ensure that these capabilities are aligned, connected, and applied consistently across countries.
This collaboration will strengthen our ability to translate Africa's health security ambitions into coordinated regulatory systems that deliver real impact — for regulators, for industry, and most importantly, for patients across Africa,” said Dr Delese Mimi Darko, Director-General, African Medicines Agency.
Under this collaboration, AMA and USP intend to cooperate across several priority areas, including advancing harmonized regulatory approaches under AMA; strengthening product quality monitoring and post-market surveillance systems; and capacity building and technical support aligned with AMA priorities.
“USP is pleased to partner with the African Medicines Agency at this pivotal moment for Africa’s health regulatory landscape. This MoU reflects our shared commitment to strengthening regulatory and quality systems, advancing regulatory harmonization, and improving access to safe, quality-assured medical products across the continent. We commend AMA’s leadership and look forward to working within its framework to apply science-based, fit-for-purpose approaches that translate this collaboration into practical programs with measurable, long-term impact for patients across Africa,” said Anthony Lakavage, JD, Executive Vice President, Secretary, USP Convention. The collaboration is reflective of the USP Convention’s Resolution to leverage USP programs and expertise to help strengthen regulatory systems around the world.
The MoU signing took place in Johannesburg, South Africa on the margins of the 3rd Africa Regional Chapter meeting of the USP Convention, convened under the theme “Partnering for Progress: Localization and Building Regulatory Capacity for Biologics and Advanced Therapies in Africa.”
The meeting brought together national regulatory authorities, industry representatives, and international partners to advance coordinated action on combating substandard and falsified medical products, supporting local manufacturing, and strengthening regulatory capacity for biologics and biosimilars.
Implementation of the MoU will be guided by mutually agreed work plans, with both organizations committing to establish a technical working group to support delivery under AMA’s coordination framework.
Notes to Editors
About the African Medicines Agency
AMA is mandated to enhance regulatory harmonization, strengthen national regulatory authorities and improve access to quality, safe and efficacious medical products across the African continent.
About the U.S. Pharmacopeia (USP)
Media Contacts
AMA : Kakazi Kacyira – Communications Officer kakazik@au-ama.africa
USP : Carol McKay – Sr. Communications Manager mediarelations@usp.org