Survey - Novel excipients: why don't we use them?

Category: IPEC Europe
  • 10 Jul 2020

Do we need them?

  • Novel excipients foster innovation and better treatment options.
  • Innovator and generic companies need novel excipients to increase the bioavailability of poorly soluble APIs or as a base for new drug delivery systems.
  • Novel excipients help to re-formulate drugs to improve quality and safety.

Why aren't they used?

  • A USP survey reported that regulatory issues were the most frequently cited challenges not to use novel excipients.
  • In Europe commercially sensitive and proprietary information is not protected building a barrier to innovation.

What needs to happen?

  • Bring Europe in line with other global markets, establish a regulatory pathway for novel excipients (e. g. Master File system).
  • Innovator and generic companies must declare their regulatory needs for novel excipients to drive innovation.

How can I help?

  • Complete this survey by 31 July 2020; provide examples where innovation was blocked because a novel excipient could not be selected due to regulatory barriers.

Complete the Survey

Please note: this survey is intended for drug formulators and excipient users.