United States Pharmacopeial Convention

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Seventy-second World Health Assembly (A72/1)
Agenda Item: 
12.2 Member State mechanism on substandard and falsified medical products

Thank you for providing us with an opportunity to share our comments at the 72nd 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 continuing its role as a partner in the WHO Member State mechanism on substandard and falsified (SF) medical products.

USP commends WHO for its continuing leadership in championing the Member State mechanism to address SF medicines.

USP remains committed to our involvement in the MSM as a technical resource to the Working Group of Activity C: improving Member States’ understanding of detection technologies. Through the Promoting the Quality of Medicines (PQM) program supported by USAID, USP shares field reports with the Global Surveillance and Monitoring System and supports regulatory agencies in strengthening quality assurance systems.

USP welcomes the opportunity to continue to collaborate with the United States government and with WHO in the following additional areas of the MS mechanism:

• Activity D: increasing Member States’ knowledge of the links between SF medicines and access to quality products;
• Activity E: Developing and leveraging activities for effective risk communication and making recommendations for awareness campaigns; and
• Activity F: Enhancing Member States’ capacity to expand awareness, impact, and outreach.

With the active engagement of scientists, practitioners, patients, and consumers supporting the work of regulators and public health advocates, we can stem the tide of SF medicines. We remain committed to support the public health mission and the ongoing leadership of the WHO in this matter.