The U.S. Pharmacopeia (USP) has long been recognized as an international leader in medicines quality and supply chain integrity. In 2017, the Asia-Pacific Economic Cooperation (APEC) forum designated USP as an APEC Center of Excellence (CoE) through the sponsorship of the U.S. FDA. USP has advanced its leadership across the region through work that supports APEC economies in the dissemination and implementation of the APEC Supply Chain Security Toolkit, including through trainings and sharing best practices. While much has happened since USP’s CoE designation – including the COVID-19 pandemic, advances in technology, and geopolitical realignment in the region – science-based regulatory cooperation remains a key focus for APEC stakeholders. To advance this goal, USP and the U.S. FDA are co-hosting the APEC Medical Product Supply Chain Dialogue as a signature event of the U.S. host year for APEC in 2023. In my keynote remarks, I highlighted the following elements of a strong medicines supply chain.
Ingredient and product quality assurance
The potential for variation in medical product manufacturing, distribution and regulatory capability across regions and economies can present challenges to ensuring quality and pose threats to patient safety and public health. USP recognizes that facilitating the exchange of best practices, tools, and standards among stakeholders, including regulators, is important for enabling quality throughout the medical product supply chain. Quality standards and related tools – supported by appropriate regulatory capability and enforcement – can help promote quality across the pharmaceutical product lifecycle, from the sourcing of active and inactive ingredients to packaging, labeling, distribution, and point-of-care administration. Adherence to standards facilitates a supply of medicines with consistent quality, no matter which company produces them or where they are made. Manufacturer adherence to public quality standards also gives regulators confidence when reviewing drug product applications and conducting related compliance activities. Use of standards enables efficient regulatory processes – from pre-market reviews to facility inspections that help ensure good manufacturing practices – to help speed market access for quality products and facilitate post-market surveillance.
We need to invest in regulatory capabilities to build a stronger supply chain. Each year, regulators review thousands of applications to authorize medicines in their countries and must monitor compliance with quality standards once medicines reach the market through post market surveillance. The challenge is even more pronounced as manufacturers develop new medicine modalities. During a pandemic situation, regulatory agencies need to be resourced adequately to act quickly to help ensure access to essential preventatives and treatments while sustaining public trust. USP works with FDA, APEC economies and other stakeholders to advocate for investments in regulatory capabilities, and we leverage our resources to help build these capabilities. USP provides training programs on the use of USP standards and works with regulators in low- and middle-income countries to facilitate regulatory capability building. Much of this work is supported by donors, particularly the U.S. Agency for International Development, through USP’s Promoting the Quality of Medicines Plus program that is working in more than 26 countries.
Threats to public health, including emerging pathogens that transcend our borders, make international cooperation essential to advancing medicines supply chain resilience and health equity. Such cooperation includes USP’s work through regional forums like APEC and APEC’s Regulatory Harmonization Steering Committee to share best practices, guidelines, and standards for quality medicines. Additionally, such cooperation includes our work with stakeholders in the Asia-Pacific and beyond to address supply chain vulnerabilities and bolster preparedness for potential future public health emergencies. USP also engages with national pharmacopeias through the Pharmacopeial Discussion Group and related forums to advance convergence of standards to streamline processes collectively in the interest of efficiency for manufacturers and regulators. The impact of such cooperation is magnified by USP staff working in every region of the world, dozens of official USP collaborations with global regulatory agencies, legal recognition of USP documentary standards in more than 50 countries, and use of USP Reference Standards in more than 150 nations.
Supply chain security
The medicines supply chain is more resilient than that of many other products but remains vulnerable to disruptions that can lead to shortages and increases in substandard and falsified medicines. Increased proliferation of substandard and falsified medicines can stem from drug shortages and pandemics like COVID-19 as a result of high demand and scarce supplies. Tragically, this can include deliberate contamination, such as what occurred with the toxic diethylene glycol contamination associated with certain allergy, cold, and cough medicines. Quality standards are an essential part of the solution, from addressing the sourcing of raw materials to online sales from internet pharmacies that operate outside of established systems for surveillance. USP’s quality-focused solutions include tools with practical strategies to help detect substandard and falsified medicines, including those intended for the treatment of COVID-19.
A resilient medicines supply chain is one that withstands acute disruptions so that safe, quality medicines are supplied to patients around the globe, in adequate quantities, when they are needed. Channeling investments and policy reforms needed to ensure resilience depends in part on access to data and insights that allow understanding of both upstream and downstream elements of the supply chain to address potential vulnerabilities. USP’s work in this area includes development of an early-warning capability for potential disruptions in the upstream medicines supply chain. Known as the USP Medicine Supply Map and launched in 2021, this capability leverages more than 250 million data points – some proprietary, but mostly public – spanning 92% of generic medicines approved in the U.S. in a platform that assesses the vulnerability of specific medicines to supply chain disruptions.
Through assessment of capacity to provide medicines within the global supply chain, it’s become increasingly clear that over-reliance on sourcing of medicines from a few countries can contribute to global supply chain vulnerabilities and potential disruptions. Adoption of advanced manufacturing technologies that can enable production efficiencies is gaining increased attention from stakeholders and policymakers as one solution to help increase manufacturing of medicines in more nations and across more regions. Alongside increased utilization of excess batch manufacturing capacity in many regions, expanded adoption of advanced manufacturing technologies can further bolster geographic diversity in sourcing and medicines supply chain resilience. USP is contributing quality-focused solutions through a broad portfolio. These include USP’s recently opened Advanced Manufacturing Technology Lab, which provides analytical lab services to help lower barriers to adoption of advanced manufacturing technologies.
Trust is both an essential element of a strong medicines supply chain and the outcome of that strength. This concept includes trust in ingredient and product quality assurance, regulatory capability, international cooperation, supply chain security, resilience, and manufacturing capability – all of which are essential to ensuring a strong medicines supply chain. A regulator’s ability to enforce quality standards, a manufacturer’s ability to adhere to them, and a region’s capacity to produce and ensure supplies of quality medicines, for example, help make sure that patients can get their prescriptions filled at local pharmacies and trust that the medicines they receive will be safe and work as they should. As a standards-setting organization, USP is uniquely positioned to help.
As USP has done for more than 200 years, we will continue to evaluate and address opportunities to meet evolving stakeholder needs and emerging public health priorities, through standards and other quality-focused solutions. We will continue to convene international regulatory bodies, industry, and health policymakers to advance quality in the global supply chain for medical products, helping to ensure that patients have access to the quality medicines they rely upon.