USP and FDA Lead Effort to Bolster Resilience of Global Medicines Supply Chain During APEC United States Host Year

FDA-USP-led dialogue will highlight insights and lessons learned from the COVID-19 pandemic to foster greater cooperation across APEC economies on supply chain issues for medical products

Rockville, MD, April 25, 2023 – The U.S. Pharmacopeia (USP) today announced the opening of the April 25-26 Asia-Pacific Economic Cooperation (APEC) Medical Product Supply Chain Dialogue at its headquarters in Rockville, MD. Cosponsored by USP and the U.S. Food and Drug Administration (FDA), the program aims to accelerate APEC and global efforts to strengthen the resilience of global medical product supply chains.

“The medicines supply chain is more resilient than those of many other products but remains vulnerable to disruptions that can lead to shortages and increases in substandard and fake medicines,” said Ronald T. Piervincenzi, Ph.D., CEO of USP. “USP is proud to join with the U.S. FDA to convene the APEC member economies to share insights and collective experience in strengthening the medical product supply chain – from upstream sourcing of ingredients to downstream distribution – and ensuring supplies of trusted, quality medicines around the world.”

As a regional forum of 21 member economies, APEC is prioritizing dialogue among its members on challenges in medical product supply chains. In 2017, APEC named USP a Center of Excellence (CoE) to promote the exchange of related best practices, tools, and quality standards. With sponsorship from FDA, USP helped develop the APEC Supply Chain Security Toolkit and, as part of the CoE, is supporting APEC economies with global dissemination and implementation of the toolkit through trainings and sharing best practices.

“The Medical Product Supply Chain Dialogue convenes international regulators, industry, academia, nonprofits, and multilateral organizations to discuss public health priorities, the impact of the COVID-19 pandemic on supply chains, and valuable tools available to help ensure supply chain security,” said Leigh Verbois, Ph.D., Director, Office of Drug Security, Integrity, and Response, at FDA. “The dialogue will accelerate APEC and global efforts to address vulnerabilities of global medical product supply chains and facilitate preparedness for future public health emergencies.”

Background & Agenda

The Medical Product Supply Chain Dialogue is one of several gatherings of APEC stakeholders during the U.S.’s 2023 host year, which is part of the country’s broader commitment to advance fair and open trade and investment across the region, and to help create a “resilient and sustainable future for all.”

The two-day agenda for the Medical Product Supply Chain Dialogue includes presentations and panel sessions on ensuring quality throughout the medical product supply chain, mitigating risks, and the role of regulation and USP quality standards in supporting supply chain resilience. Specific topics include:

  • Identifying vulnerabilities in the upstream supply chain
  • Mitigating and managing risks in excipient quality
  • Manufacturing solutions to strengthen the global medicines supply chain
  • Strengthening supply chain integrity through regulatory systems for pandemic preparedness and response
  • Safeguarding patients from impurities in the drug supply chain
  • Securing the downstream supply chain through good distribution practices, post-marketing surveillance, and safe internet pharmacies

For more information on USP activities aimed at bolstering the medicines supply chain and addressing ongoing vulnerabilities, click here.

About USP

USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality resources and standards for medicines, dietary supplements and food ingredients. Through our resources, standards, advocacy and education, USP helps increase the availability of quality medicines, supplements and foods for billions of people worldwide.

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