Throughout the world, new or novel excipients are only approved within new drug applications, and no independent regulatory approval process exists for new excipients, new uses, or levels of an excipients use - apart from a new drug approval process. Because of this, in 2007, IPEC-Americas Safety Committee developed a novel excipient evaluation procedure as an independent excipient evaluation process to help reduce the cost and uncertainty related to use of novel excipients in pharmaceutical formulations; thereby encouraging their use in drug development programs and encouraging drug formulation innovation.

This led to an expanded and adaptable procedure and process which is now used by committees appointed and administered by Alclairo PDG, Inc. Its goal is to provide an independent evaluation of safety and regulatory data relating to a proposed new excipient use in a future regulatory filing. The process is designed and intended to mirror that of regulatory agencies, beginning with the U.S. Food and Drug Administration, thereby providing confidence to pharmaceutical manufacturers that the excipient will be found acceptable in their submitted formulations.

Read about the IPEC New Excipient Safety Evaluation Procedure Brochure

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.

Pharm Tech November 2009 Article -- click here

NESEP WEBINAR RECORDING AVAILABLE - 

If you are interested in viewing the November 23, 2010 Webinar featuring Christopher DeMerlis, Regulatory Affairs Manager, Colorcon; Elaine V. Knight, Ph.D, Interdisciplinary Scientist and Toxicologist, National Institute of Health; and Robert Osterberg, Ph.D.,  Senior Consultant, Pharmacology/ Toxicology, Aclairo PDG, Inc., please contact:

Kim Beals
Executive Director
IPEC-Americas
kim.beals@ipecamericas.org
703-875-8712  

This review procedure is administered by:

Aclairo Pharmaceutical Development Group
Vienna, Virginia
703-506-6760
Robert Osterberg, Ph.D.
rosterberg@aclairo.com