Survey - Novel excipients: why don't we use them?Category: IPEC Europe
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.