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.

Pharmaceutical IconSupporting 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.

Resources on USP’s emerging standards approach:

News:

  • Catherine Sheehan, USP's Senior Director, Growth Programs, Foods and Excipients, will give an overview of USP's standard setting process and evolving approaches to excipient standard setting in support of early-stage drug development at the 3rd LNP Formulation & Process Development Summit in Boston in April 2024
  • Meet us at Excipient World in Kissimmee, FL in May 2024.
  • Catherine Sheehan, USP's Senior Director, Growth Programs, Foods and Excipients, presented on USP's Iterative Approach to Excipient Standards Development and its Application to Novel Excipients at Excipient World 2023 in May 2023.
  • Anni Chang, USP's Senior Scientist II, Excipients presented on the Importance of Standard Setting in Excipients at the 2nd LNP Formulation & Process Development Summit in Boston in April 2023.
  • USP’s CSO, Jaap Venema and Senior Director, Catherine Sheehan share views in a Nature news and analysis article on Novel Excipients (requires subscription).

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)

Read more about FDA's PRIME Program

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

Have a question?

Contact us at excipients@usp.org