Consultation of Draft Guidance Documents: Identifying and Labelling Medicinal Ingredients, Generic Drug Equivalence: Medicinal Ingredients

Current status: Closed

This consultation ran from April 8, 2019 to June 17, 2019.

Health Canada is proposing amendments to the Food and Drug Regulations that would provide greater clarity to the pharmaceutical industry on criteria for which regulatory pathway to follow when filing generic drug submissions to Health Canada and, requirements for labelling for new drug products. The draft guidance documents Identifying and Labelling Medicinal Ingredients and Generic Drug Equivalence: Medicinal Ingredients outline the implementation of the regulatory proposal that was consulted on in Canada Gazette I.

Who was the focus of this consultation?

The consultation was focussed on:

• The pharmaceutical industry
• The provinces and territories
• Health care professionals

Goals of the consultation

The goal of this consultation was to receive feedback on the guidance documents Generic Drug Equivalence: Medicinal Ingredients and Identifying and Labelling Medicinal Ingredients. These guidance documents provide information on the submission requirements for generic drug products; and, labelling and identifying the medicinal ingredient in new drug products. The proposed regulations and guidance document are aimed at providing more clarity, consistency, transparency and predictability for manufacturers in filing drug submissions. The guidance documents provide details on the implementation of the regulatory proposal that was out for consultation in Canada Gazette I.

Related information

• Canada Gazette Part I consultation Improving Access to Generics (which includes the proposed changes to the Food and Drug Regulations).
• The draft guidance documents: Identifying and Labelling Medicinal Ingredients; Generic Drug Equivalence: Medicinal Ingredients.

Contact us

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

Telephone: 613-957-1058
Email: hc.policy.bureau.enquiries.sc@canada.ca