USP and African Institutions Provide Free Access to Pharma Production Resources

The United States Pharmacopeia (USP) announced on June 13, 2024 that it is collaborating with the African Union Development Agency (AUDA –NEPAD), the Africa Centres for Disease Control and Prevention (Africa CDC), the Association of African Universities (AAU), and the Federation of African Pharmaceutical Manufacturers Associations (FAPMA) to advance access to medicines and vaccines. USP grant-free access to the United States Pharmacopeia–National Formulary (USP–NF) and USP’s education training library to all stakeholders in Africa, including regulatory authorities, laboratories, academic institutions, and manufacturers.

The new initiative will support African-led efforts, such as CDC’s New Public Health Order and AUDA-NEPAD's Pharmaceutical Manufacturing Plan for Africa, to increase the production of medical products. The initiative also builds on USP’s efforts to expand access to medicines in Africa through the organization’s direct investment, along with donors such as the US Agency for International Development. These efforts have included capacity building with 39 African manufacturers and 33 African regional and national regulatory authorities.

“Africa’s over-reliance on pharmaceutical imports created unacceptable supply chain vulnerabilities and delays during the COVID-19 pandemic,” said Jean Kaseya, MD, director-general of Africa CDC, in a USP press release (1). “We are committed to working with partners [such as] USP to build African manufacturing capacity to ensure that never happens again.”

“Development and growth of the pharmaceutical and vaccine manufacturing sector in Africa is critical to building sustainable and equitable access to health products in Africa,” said Symerre Grey Johnson, director for Human Capital and Institutional Development of AUDA-NEPAD, in the release. “With the actualization of the African Medicines Agency coupled with the African Free Trade Agreement and high-level commitments made by the African Union and numerous heads of states, the enabling conditions are primed for this sector to grow.”

“The growth of pharmaceutical manufacturing in Africa hinges on a dynamic and robust workforce,” said Olusola Oyewole, PhD, secretary-general of the Association of African Universities (AAU), in the release. “The development of a well-trained human resource pool with access to essential resources, such as those provided by USP, is crucial for educating tomorrow’s workforce, and transforming the continent’s pharmaceutical ecosystem.”

“Quality, including the adoption and scale up of accepted quality standards, must be at the heart of Africa’s expanding pharmaceutical sector,” said Emmanuel Mujuru, chairperson of FAPMA, in the release. “These resources will help African manufacturers move ever closer toward a thriving, quality-focused African pharmaceutical industry.”

The collaboration was announced at the inaugural meeting of USP’s Africa Regional Chapter. The Africa Regional Chapter brings together perspectives and expertise to identify priority issues. USP’s regional chapters will provide a forum for stakeholders to collaborate to advance pharmaceutical manufacturing and other priorities. There are more than 5000 quality standards in the USP–NF for both chemical and biologic drugs, APIs, and excipients, therefore providing a comprehensive source for quality standards.

Reference

1. USP. African Institutions and USP Announce Free Access to Resources to Support Production of Quality Medical Products in Africa. Press Release. June 13, 2024.