- USP is engaged with both FDA and industry in its transparent, science-driven standards development process to support broad applicability and alignment with regulatory expectations across markets.
- Early industry engagement with USP—such as sharing scientific data, submitting methods, and providing public comments—helps ensure evolving standards reflect real-world practices and improve clarity across regulatory pathways.
- USP standards offer a common scientific foundation that companies can reference in FDA submissions, helping streamline reviews and reinforce shared expectations for quality and regulatory predictability.
USP recently co-hosted a webinar with experts from the U.S. Food and Drug Administration (FDA) and the Association for Accessible Medicines (AAM) to examine how public quality standards help contribute to regulatory predictability. Attendees, including regulatory affairs professionals, scientific and technical professionals from across the industry, and consultants specializing in standards and compliance, submitted hundreds of questions for panelists—far too many to cover during the session. Quality Matters sat down with Matt Vankoski, USP Director of Donations, to discuss the most commonly asked audience questions—as well as a few he was unable to address live—in a two-part series.
Read the first part in the series here.
Q: How is USP harmonized with other pharmacopeias globally?
Matt: USP engages in several mechanisms to support global alignment of pharmacopeial standards through:
- Pharmacopeial Discussion Group (PDG): USP works with the European, Indian, Korean and Japanese pharmacopeias (and World Health Organization (WHO) as an observer) to harmonize excipient monographs and general chapters, helping ensure that tests yield equivalent results and decisions across regions.
- International Meeting of the World Pharmacopeias (IMWP): USP collaborates with WHO and pharmacopeias from around the world to share knowledge, advance Good Pharmacopeial Practices, and coordinate rapid responses to public health emergencies such as COVID-19.
- Adopt Agreements: USP authorizes other pharmacopeias to reproduce USP standards.
- Bilateral Agreements: USP jointly develops standards via prospective harmonization—aligning methodologies for selected small molecule medicines, typically sponsored by innovators, until the resulting pharmacopeial standards become official across all participating compendia.
Q: How does USP prioritize which standards to develop?
Matt: USP maintains a dedicated cross-functional team responsible for identifying medicines with the greatest potential to improve people’s health around the world and deliver meaningful impact for patients. As an example, the small molecules team uses a machine learning model that utilizes various data sources including the number of prescriptions, units produced, manufacturers, dosage forms, market size, and other relevant data to forecast how USP standards will be used in the future. By linking these inputs directly to patterns of medicine utilization, the model helps anticipate where standards will have the greatest impact on patient availability, product quality and overall public health. USP uses this assessment, along with human judgment, to develop USP’s priority standards list. This evaluation process is ongoing on a bi-annual basis to ensure we incorporate any changes within the data sources. This priority list is published as part of the USP pipeline.
Q: How can organizations participate in USP’s standards-setting activities?
Matt: Organizations may contribute by submitting data, methods or materials to help develop or revise monographs. They can also provide feedback during Pharmacopeial Forum (PF) public comment periods. Additionally, individuals from all corners of the health ecosystem can volunteer to serve on USP Expert Committees or Panels. These are the independent Expert Volunteers who, serving up to 5-year terms, work alongside USP staff to develop and revise our standards. USP welcomes participation from across industry, academia, healthcare, and regulatory bodies. USP also regularly hosts workshops and other public events, to solicit industry insights and feedback from all interested stakeholders, including industry and regulators. To learn more, visit the USP Donations Program page.
Q: How can industry work with USP (and FDA) to develop new monographs or monograph revisions based on products awaiting regulatory approval?
Matt: The USP Pending Monograph Process (PMP) is specifically designed to allow USP, FDA, and industry to collaborate on monographs while a product is awaiting approval by FDA. Please see the PMP guidelines for more information.
This approach allows for development of monographs or monograph revisions for articles awaiting approval by FDA, and it permits publication of these proposals in the Pharmacopeial Forum for notice and comment where required in accordance with USP’s standard revision processes. Following PF publication, these proposals remain in an unofficial status until FDA approval of the marketing application held by the donor. The PMP allows the new or revised monograph to become official more rapidly than would be possible if development began only after final FDA approval. For additional information, including recommendations for applicants and frequently asked questions, please see the draft guidance, Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process Guidance for Industry. If you are interested in working with USP to develop or revise a monograph through the PMP, please contact Donations@usp.org.
Q: What education and training resources does USP offer to promote consistent application of standards?
Matt: USP offers a comprehensive portfolio of education and training resources—including instructor-led courses, virtual workshops and on-demand modules—designed to support consistent interpretation and application of compendial standards. These programs help organizations strengthen their understanding of USP–NF requirements, proper use of reference standards and best practices for integrating compendial expectations into quality and regulatory systems. For the latest offerings, visit the Events & Training section on the USP website.
We encourage companies to explore the USP pipeline to see which standards that are currently in development may impact your products or areas of interest. While you're there, review our Priority List to identify opportunities where your expertise or contributions can advance new standards development.
If you’d like to learn more about how the process works or how to get involved, connect with our Donations team at Donations@usp.org.
