Guidance Document: The Management of Drug Submissions and Applications

From Health Canada


This guidance document gives sponsors and Health Canada staff operational direction and guidance when managing information submitted in accordance with the Food and Drugs Act and Regulations.

Who this guide is for

  • Sponsors of pharmaceuticals, biologics, and radiopharmaceutical drugs for human use

In this guide

View complete Guide

Download PDF (688 KB, 73 pages)

Details and history

  • Published: Pre 1993/12/19
  • Updated: 2021/07/07
  • Consulted: N/A
  • Part of topic(s): Guidance on legislation

For assistance

Contact us:

Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Canada
1600 Scott Street
Holland Cross, Tower B
2nd Floor, Address Locator 3102C1
Ottawa, Ontario
K1A 0K9
Facsimile: 613-941-1812

Related Services

  • Information related to Health Canada’s regulation of drug products and related information can be found on the Health Canada webpage on Regulations of Drug Products

Related guides and help

Related acts and regulations

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