Release of Draft Guidance Documents Generic Drug Equivalence: Medicinal Ingredients and Identifying and Labelling Medicinal Ingredients

April 8, 2019
Our reference number: 19-105022-902

Health Canada is pleased to announce the release of the draft guidance documents Generic Drug Equivalence: Medicinal Ingredients and Identifying and Labelling Medicinal Ingredients for a 70-day comment period.

The draft guidance documents support the proposed changes to the Food and Drug Regulations (Improving Access to Generics) recently published in Canada Gazette, Part I. The draft guidance documents outline:

• the general principles and considerations for demonstrating that the safety, efficacy, and quality of a generic drug product pursuant to subsection C.08.002.1(1) of the regulations, and
• outlines recommendations for identifying and labelling the medicinal ingredient in new drug products

Comments on these draft guidance documents should be submitted within 70 days to the contact below:
Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Canada
1600 Scott Street
Holland Cross, Tower B
2nd Floor, Address Locator 3102C5
Ottawa, Ontario
K1A 0K9

Facsimile: 613-941-1812
E-mail: hc.policy.bureau.enquiries.sc@canada.ca