Novel Excipients Knowledge Hub

Novel excipients hold great promise for therapeutic innovations but come with significant risk related to regulatory issues, safety concerns, and potential additional cost. Without globally aligned regulatory mechanisms, novel excipients may increase the risk of discontinuation of drug development or costly drug product reformulation. In a survey conducted by USP in 2019, 77 % of respondents experienced challenges advancing drug formulations using novel excipients. USP is creating a new knowledge hub to share information and resources on novel excipients that will include updates on USP’s work to develop standards for novel excipients.

We are also structuring other methods to engage and support formulators, R&D scientists, QA professionals, Regulatory Affairs Manager and others in an effort to reduce the risk associated with novel excipient use, innovate, and bring new therapeutics to market. Get the process started by telling us about your top novel excipient challenges today.

Supporting the development of novel excipients

To support the development of novel excipients, USP has established an Expert Panel dedicated to Novel Excipients. The panel is revising USP General Chapter <1074> Excipient Biological Safety Evaluation Guidelines. The panel had its kickoff meeting in November 2022.

Recognizing the strong need for a public standard in an evolving regulatory environment like novel excipients, USP has designed a more nimble and responsive stakeholder engagement model, so input can be incorporated sooner and more easily throughout the standards lifecycle. We are taking an iterative approach, so industry, industry associations, regulators, academia, and pharmacopeias will have access to “emerging standards”— standards under development, through Stimuli articles, general chapters and guidelines. This new model for stakeholder engagement and iterative approach to standards development will enable USP to be more responsive and effective at developing practical solutions for emerging quality challenges such as those currently facing novel excipients.

Public Policy Position Graphic

USP Public Policy Position:
Fostering the Use of Novel Excipients in Drug Products

USP supports policies and initiatives to facilitate the introduction and use of novel excipients that encourage increased cooperation and coordination between stakeholders and prioritize regulatory developments to support their use in new therapies and modalities.

New to USP? No problem. Learn about our standard setting process.
Stimuli article on emerging standards in Pharmacopoeial Forum 48 (3).
Emerging standards science page.

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Regulatory definitions and programs

FDA's PRIME Program

U.S. Food and Drug Administration (FDA) has a pilot Program for the Review of Innovation and Modernization of Excipients (PRIME)

EMA's Current Guideline

European Medicines Agency (EMA) defines novel excipients in its guidelines on excipients in the dossier for application of marketing authorization of medicinal products

Read EMA's current guideline

Novel Excipients