IPEC e-newsletter - Excipients Insight June/July 2017 - 10-07-17


Inside this issue


FDA to meet with industry groups on novel excipients

The FDA's Office of Product Quality (OPQ) – part of the Centre for Drug Evaluation and Research (CDER) has agreed to meet with the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ Consortium) and IPEC-Americas later this year to discuss the need for novel excipients as a gap in manufacturing innovation.

An update from the American Association of Pharmaceutical Sciences (AAPS) Excipients Focus Group (EFG) notes that after preliminary exchanges with the OPQ, it is clear the agency "supports the concept of novel excipient availability and use independent of specific drug products", and "is interested in discussing this concept further [to examine] how this effort can be advanced."

IQ Consortium's Novel Excipients Working Group defines a novel excipient as "a material or a composition that has not been previously used in an approved drug product in the US… or that has been previously used in an approved drug product" that can be used used to facilitate a new route or administration or elevated dosing, enhance pharmaceutical safety or efficacy or enable the formulation of low-solubility compounds, amongst other applications.

"FDA will work with [the] IQ Consortium and IPEC to coordinate a mutually agreeable date and time to meet with CDER leadership to further discuss possibilities of collaboration," said the EFG.




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