FDA sets up Novel Excipient Review Pilot Program

Manufacturers can submit their novel excipients for FDA review under the voluntary Novel Excipient Review Pilot Program.

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The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) has launched the voluntary Novel Excipient Review Pilot Program (Pilot Program) to allow excipient manufacturers to obtain FDA review of certain novel excipients prior to their use in drug formulations.

According to the FDA, the programme “will foster development of excipients that may be useful in scenarios in which excipient manufacturers and drug developers have cited difficulty in using existing excipients”.

Initially the programme will be available for two types of novel excipients, those:

  1. not been previously used in FDA-approved drug products
  2. without established use in food.

The CDER stated that the first stage is an initial proposal, in which excipient manufacturers provide a high-level overview of their novel excipient. It plans to accept four initial proposals (two for the first year and two for the second year) but will consider accepting more proposals as resources allow. Excipient manufacturers whose initial proposals are accepted would then enter the second stage, in which they would provide a full data package consisting of toxicology and quality data.

The initial proposal stage involves excipient manufacturers submitting brief summaries describing the novel excipient, its proposed use and the public health or drug development need addressed by the excipient. It is also expected to include a a summary of the supportive data generated or collected so far and some indication of the timing of any subsequent data needed for submission of the Full Package. To aid in the process, CDER have provided an initial proposal model content outline.

According to the FDA, initial proposals will be accepted based on the following factors, among other considerations:

  • Potential public health benefit of the novel excipient (for example, excipients that may facilitate opioid abuse-deterrent formulations or promote the development of new therapies for serious and life-threatening diseases)
  • Likelihood of the novel excipient manufacturer’s ability to submit a complete package within the established timeframe
  • Overall potential of the novel excipient to meaningfully improve pharmacokinetic characteristics that may lead to novel drug development.

Interested excipient manufacturers should submit initial proposals via email at [email protected]. Proposals for the pilot programme will be accepted until 7 December 2021.