Thank you for providing us with an opportunity to share our comments in advance of the opening of the 73rd World Health Assembly.
The United States Pharmacopeial Convention (USP), a nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements worldwide, is committed to supporting the public health response to COVID-19, including efforts to build a more resilient global medicines supply chain.
Patients around the world depend on medicines—and their ingredients—sourced from and manufactured around the globe. Acute disruptions, such as the COVID-19 crisis, expose vulnerabilities in the supply chain and cause harm to patients.
USP therefore supports the global community’s efforts to strengthen supply chain resilience, including advancing the use of pharmacopeial standards, to help ensure the supply of quality medicines. In particular, we call on all stakeholders to:
- Increase transparency, including expanding requirements for industry and healthcare providers to report on existing or potential drug shortage indicators.
- Bolster quality assurance through regulatory workforce training and national drug quality control laboratories, and industry compliance to international standards, including good manufacturing practices.
- Strengthen regulatory systems to review new applications more efficiently, conduct risk-based post-market surveillance, and protect patient safety.
- Invest in advanced manufacturing technologies to enable more efficient and nimble production of essential medicines and vaccines.
- Facilitate local production capabilities to secure a supply of essential, quality-assured medicines and vaccines during a crisis.
- Enhance global cooperation through increased information-sharing and recognition and reliance agreements among pharmacopeias and regulators to coordinate access to essential medicines and vaccines and disincentivize substandard and falsified medicines.
Ensuring a strong global supply chain is critical to the COVID-19 response and to addressing future global crises. USP is committed to working with global stakeholders on a concerted and coordinated response.