IPEC Novel Excipient Evaluation Procedure
Throughout the world, new or novel excipients are only approved within new drug applications, and there is no independent regulatory approval process for new excipients. In 2007 IPEC-Americas Safety Committee proposed and developed the IPEC Novel Excipient Evaluation Procedure. This independent excipient evaluation process is anticipated to reduce the cost and uncertainty related to use of novel excipients in pharmaceutical formulations, thereby encouraging their use in drug development programs and expanding drug formulation innovation.
The goal of the IPEC Novel Excipient Evaluation Procedure is to provide an independent evaluation of the safety and regulatory acceptance of a new excipient before a regulatory filing. The process is meant to mirror that of regulatory agencies, ideally providing confidence to pharmaceutical manufacturers that the excipient will be acceptable in their formulations.
For additional information please read the November 2009 Pharmaceutical Technology Position Paper authored by Christopher DeMerlis, Jay Goldring, Ph.D., Ranga Velagaleti, Ph.D., William Brock, Ph.D., and Robert Osterberg, Ph.D.