USP’s iterative approach to standards development
Today’s rapidly evolving and increasingly complex pharmaceutical landscape requires new approaches to the development of quality standards. USP’s Emerging Standards program is an agile, iterative approach to standards development, where an Emerging Standard – a potential standard in its initial development phase – is shared with the community to stimulate dialogue and participation that may contribute to these documents potentially achieving official status in the future by going through USP’s official standards-setting processes.
USP’s Emerging Standards program enables collaboration with scientific experts and stakeholders to:
- Browse, test, and apply Emerging Standards
- Submit comments, contribute information, share Emerging Standards, donate methods
- Subscribe to be notified of new and updated Emerging Standards
Help shape the standard.
This approach provides greater visibility into the development process while giving the community an opportunity to shape standards from an early stage. For example, we include the validation and other scientific data on which an emerging standard is based, which gives you, members of the scientific community, the ability to understand and respond to this data.
Anticipate change.
Emerging standards may also be accompanied by the release of reference materials, which help you to evaluate and contribute to a potential standard. The transparent nature of this approach allows you to better understand, react to and plan for implementation of an emerging standard, providing greater predictability and certainty for both manufacturers and regulators.
Accelerate drug development.
Emerging Standards offer early insight on novel ingredients, technologies, or processes. This helps manufacturers plan for possible compendial expectations early in the development process, reducing uncertainty and facilitating smoother progression through the compendial pathway.
Emerging Standards are not official USP Standards.
Unlike official USP standards, Emerging Standards are ideas in development presented to the scientific community for feedback and discussion, with the ultimate goal of potentially evolving into official USP Documentary Standards. Input received at this early stage can significantly influence and shape an emerging standard’s development trajectory.
What is USP’s Emerging Standards program?
USP launched the Emerging Standards program, a new approach for developing and sharing information with stakeholders, in 2023. Through the Emerging Standards program, USP posts early concepts for potential standards at a dedicated section of USP.org, allowing members of the scientific community to view related documents, post comments, ask questions, engage in discussion, and share the Emerging Standards with colleagues.
How are Emerging Standards different than official USP standards?
Because Emerging Standards are concepts in early development, not yet formalized through USP’s official standards-setting processes, they are not official USP compendial standards. Emerging Standards are a resource for informational purposes only. Emerging Standards do not reflect USP or USP’s Expert Body opinions of future revisions to the official text of the USP‐NF.
Can an Emerging Standard become an official USP compendial standard?
To become an official USP compendial standard, an Emerging Standard would go through USP’s formal notice and comment procedures through publication in the Pharmacopeial Forum.