Consultation on proposed revisions to the Guidance Document: Management of Drug Submissions

From Health Canada

Current status: Closed

Opened on October 25, 2018 and will close to new input on November 22, 2018.

Health Canada is revising the Guidance Document entitled: The Management of Drug Submissions (MDSG). Stakeholders are invited to submit feedback on the proposed changes outlined in this Notice, which will be taken into consideration prior to the finalization of the revised guidance.

Join in: how to participate

Send an email to: with your ideas or comments to make yourself heard.

Who is the focus of this consultation

We will engage with:

  • Industry stakeholders including: Generic Drugs, Innovators / Biologic Drugs, Over-the-Counter (Non-prescription Drugs), and Radiopharmaceutical Drugs
  • Interested members of the public and consumers

Proposed changes

Your ideas and inputs are sought around the following proposed changes:

  • Process changes
  • Clarification Requests
  • Performance Standards

Related information

Contact us

Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Canada
Address Locator 3102C3
Holland Cross, Tower B
1600 Scott Street
Ottawa, Ontario
K1A 0K9

Telephone: 613-948-4623
Facsimile: 613-941-1812

Page details

Date modified: