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

Category: IPEC Europe
  • 10 Jul 2020

The survey is now closed. 

We received many insightful answers and we thank all of you who took part in identifying the barriers that you face every day with the use of novel excipients.
Your feedback is very important to us.

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 August 2020: provide examples where innovation was blocked because a novel excipient could not be selected due to regulatory barriers.

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