ARCHIVED - Consultation on the Draft Guidance Document: Submissions Relying on Third-Party Data [Literature and Market Experience]
Notice to the reader:
The online consultation is now closed. The final guidance is available now.
The Guidance outlines criteria for assembling new drug submissions (or supplements) involving pharmaceuticals and/or biologics and radiopharmaceuticals that substantially rely on literature and market experience and clarifies the evidence requirements for the proposed commercial products.
This guidance document reflects current thinking and practices on submissions relying on third-party data (SRTD).
How to Get Involved
This consultation is open for a 90-day comment period starting June 13, 2014 until September 13, 2014.
For More Information
For general questions and concerns, please contact:
- Policy_Bureau_Enquiries@hc-sc.gc.ca
- Health Canada
Health Products and Food Branch, Therapeutic Products Directorate
Bureau of Policy, Science and International Programs
Address Locator 3102C5
Holland Cross, Tower B
1600 Scott St.
Ottawa, Ontario
K1A 0K9 - Telephone: 613-948-4623
Interested parties are encouraged to provide comments by September 13, 2014.
Reporting to Canadians
A summary of the results from the consultation on the guidance documents will be made available.