Introduction
While Donald Trump’s policies and tariff proposals make headlines in the United States, health scientists and academics remain focused on the horizon, seeking collaboration beyond borders and ensuring medication quality remains a cornerstone for global health.
USP Convention: Key Takeaways
The United States Pharmacopeia (USP) convention, held from May 5 to 8, 2025, brought together hundreds of representatives from the U.S. health and science ecosystem who remained undeterred by geopolitical disruptions, health crises, and protectionist debates. Key elements highlighted for the immediate future include mitigating supply shortage risks, maintaining medication quality, optimizing prices, promoting biosimilar drugs, and enhancing digitalization.
Participants and Their Roles
The event featured dialogue among academic institutions, manufacturers’ associations, government bodies, NGOs, patient organizations, and healthcare professionals. The goal was to chart a path toward a more resilient, sustainable, and equitable global medication supply chain. Notably, the USP is actively expanding its international presence.
- Mexico was represented by Cofepris authorities, including Esther Ruiz from the Evidence and Risk Management Commission, as well as members of the Mexican Pharmaceutical Manufacturers Association (Amelaf), led by Juan de Villafranca, who has been actively engaging with the USP for three years.
- Representatives from Brazil, Colombia, Argentina, and Peru were also present.
USP’s Strategic Priorities (2020-2025)
The USP’s strategic priorities transcend political contexts and focus on long-term structural challenges, including:
- Multilateral Collaboration: The USP’s success hinges on its global network of regulators, industry, donors, and NGOs.
- Structural Reform Against Protectionism: Despite growing calls for local production in the U.S., the USP sees an opportunity to discuss geographical manufacturing concentration and essential generic drug resilience, advocating for incentives ensuring stability.
- Strengthening Resilience: It’s not just about weathering crises but building robust supply chains. Tools like the Medicine Supply Map help map real-time risks, aiding manufacturers and distributors in anticipating shortages and diversifying suppliers.
- Stabilizing the Generic Drug Market: Price crises in generics have affected accessibility. The USP advocates for policies promoting redundancy, quality, and early warning systems, along with incentives for reliable production.
- Scientific Modernization and Global Standards: The USP has responded to challenges like the pandemic, nitrosamine concerns (potentially cancer-causing compounds in some medications), and new health challenges with rapidly developed standards. Its modernized labs and leadership in advanced therapies (gene therapy, biosimilars) and green chemistry solidify its role in over 155 countries.
- Strengthening Global Capacities: Through partnerships with USAID, Unitaid (a global health agency supported by the WHO aiming to innovate and accelerate access to treatments, diagnostics, and health tools for low- and middle-income countries), and regulators, the USP has trained over 100,000 scientists and supported localized manufacturing projects in Africa, promoting self-sufficiency in vulnerable regions.
- Digitalization and Manufacturing 4.0: Adopting modern technologies and digitalized processes has enhanced the USP’s operational agility.
- Patient Participation and Advocacy: The USP recognizes patient voices as essential for closing gaps with the industry and reforming procurement policies prioritizing resilience over price.
The USP’s message is clear: the future is built through collaboration, agility, and collective commitment to resilience, not protectionism.
Amelaf’s Closeness to USP Opens Doors for Mexican Pharma Companies in the U.S.
Interviewed during the USP convention, Juan de Villafranca from Amelaf highlighted the USP’s unique position as one of the few pharmacopeias independent from regulatory agencies while working closely with the FDA. This collaboration has helped build international reach, such as in Mexico, where they’ve been working for three years to strengthen ties between the regulatory agencies of both countries.
