Inside IPEC: New Excipient Evaluation Procedure - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

Inside IPEC: New Excipient Evaluation Procedure
Pharmaceutical manufacturers often avoid putting new excipients in their formulations for fear of more regulatory oversight. IPEC has a solution.

Pharmaceutical Technology
Volume 32, Issue 1

The panel's activities are managed by a consultant on a fee-for-service basis. The interested excipient manufacturer, through direct discussions with the consultant, provides the consultant with a table of contents and summary of the expected studies needed for the review. The consultant then provides a cost proposal and timeframe based on the expected time of review and the experts' hourly fees. After the evaluation, the consultant provides the manufacturer with a report. The report can be included in the sponsor's DMF or given directly to the drug product applicant.

IPEC only tracks the number of completed reviews and plays no role in this process. IPEC does not know any of the specifics of an expert panel project. The evaluation procedure is kept confidential between the panel and sponsor.


The details of this process were developed in conjunction with FDA staff, who, in a 2006 letter to IPEC, agreed to consider the panel's conclusions when reviewing "new" excipients within NDAs. Although the agency could not guarantee that they would agree with the panel's conclusions, they welcomed the additional level of review and acknowledged the value of the process for encouraging new excipient development.


To date, IPEC's New Excipient Evaluation Procedure panel has received one submission and several others are in the planning stages. The panel represents a potential remedy to the regulatory "logjam" facing new excipient development. The panel's independent review should provide pharmaceutical manufacturers confidence that specific "new" excipients will be acceptable in their regulatory filings, thus encouraging them to use these excipients in their formulations.

Christopher C. DeMerlis is manager of regulatory affairs at Colorcon and chair of the IPEC–Americas Regulatory Affairs Committee. Jay M. Goldring, PhD, is director of toxicology at Wyeth Consumer Healthcare and chair of the IPEC-Americas Safety Committee. David R. Schoneker is director of global regulatory affairs at Colorcon. and chair of IPEC–Americas. For more information, contact Alan Mercil at IPEC–Americas, 1655 North Fort Myer Drive, Suite 700, Arlington, VA 22209, tel. 703.875. 2127, fax 703.525.5157,


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
Source: Pharmaceutical Technology,
Click here