A Center of Excellence to Secure Medicines Quality Through the Supply Chain
Pictured: Katherine Bond (USP), Erika Elvander and Maureen Goodenow of U.S. Health and Human Services, Ron Piervincenzi (USP), and Phillip Nguyen (USP)
Ho Chi Minh City, formerly known as Saigon, is Vietnam’s most populous city and lies amid a confluence of rivers. For centuries, people have lived and traded along the rivers, with the mighty Mekong winding its way through Yunnan China, Lao PDR, Myanmar, Thailand, and Cambodia, before opening into the South China Sea at the mouth of Vietnam’s Mekong Delta. Cross-border trade and travel in the Mekong Sub-region has grown over the last two decades, and with it, the proliferation of substandard and falsified medicines. These medicines penetrate markets across borders and through supply chains that have not been secured, making them vulnerable to fraud and adulteration. They threaten major public health gains and make diseases much harder to treat. With Vietnam, and now, with the Asia Pacific Economic Cooperation (APEC), USP and partners are exploring new ways to stem this tide.
Vietnam has taken major steps toward ensuring safe medicines can reach patients, and USP is proud to have been a partner along Vietnam’s journey. Promoting the Quality of Medicines (PQM), a program funded by USAID and implemented by USP, provided technical assistance to Vietnam’s medicines regulatory agencies at the national and sub-national levels, with a focus on quality control laboratories, to help them achieve and maintain internationally recognized standards and practices. More recently, USP partnered with the Drug Administration of Vietnam and other public health agencies to shape Vietnam’s quality monitoring programs for antimalarial medicines.
World Leaders Gather in Vietnam for APEC
In late August, 2017, Ho Chi Minh City hosted the Asia Pacific Economic Cooperation (APEC) Third Senior Officials Meeting (SOM3). Over the last several years, APEC economies have worked through the APEC Life Science Innovation Forum (LSIF) Regulatory Harmonization Steering Committee (RHSC) with leadership from the US FDA, to develop tools and solutions that help secure supply chains. This effort culminated in the release of the APEC Global Supply Chain Integrity ToolKit this past March . These tools and practices apply along the entire supply chain, from securing quality ingredients upstream, to downstream delivery and medicines quality surveillance.
During the APEC SOM3 meeting, the RHSC endorsed USP as a Center of Excellence for “Securing Medicines Quality through the Supply Chain.” USP joins the ranks of six academic institutions’ CoEs across different regulatory areas spanning medical product development and product life cycle.
USP contributed to the technical development of the APEC ToolKit, and piloted an APEC RHSC Center of Excellence (CoE) workshop last March as a way to share the toolkits and other quality medicines solutions. The participants included 26 regulators from 14 APEC economies, including Vietnam. The workshop featured speakers and experts from industry and the APEC Life Sciences Innovation Forum; US Department of Health and Human Services; US Food and Drug Administration; US Agency for International Development; World Health Organization; the World Bank Group, and academic institutions. It also included embassy representatives from Vietnam, The Republic of Korea and the People’s Republic of China.
Participants returned home understanding the importance of controlling the quality of raw materials and excipients from suppliers, and identifying risks to product and ingredient adulteration. They also identified challenges in distribution – like packaging and temperature control - that could cause products to degrade while in transit. Many participants said the hands-on demonstrations of technologies that screen for the quality of medicines were especially useful. We left the meetings with a sense that we are all in this together.
Linking Medicine Quality to Health and the Economy
At the Senior Officials Meeting, our focus on medicines quality has resonated with APEC economy regulators, policy makers and other stakeholders. We were thrilled to bring USP’s CEO, Dr. Ron Piervincenzi—who recently joined the APEC LSIF Executive Board—to share how public quality standards can support pharmaceutical innovation and access at the High Level Dialogue on Regulatory Convergence. Katherine related to the High Level Meeting on Health and the Economy how APEC CoEs, combined with country-based regulatory systems support, can help APEC economies to address global and regional health security concerns such as anti-microbial resistance.
At USP, we are honored to join the APEC community, and are steadfast in our commitment to better the public health through our USP-APEC CoE for Securing Medical Product Quality Through the Supply Chain.
Dr. Katherine C. Bond Sc.D. & Dr. Phillip Nguyen M.D. DABFM
Dr. Bond is Vice President of International Public Policy and Regulatory Affairs at USP. Dr. Nguyen is the new Director of International Regulatory Policy and Programs, and Director of the USP-APEC Center of Excellence.