Consultation of Draft Guidance Documents: Identifying and Labelling Medicinal Ingredients, Generic Drug Equivalence: Medicinal Ingredients

From: Health Canada

Current status: Open

Opened on April 8, 2019 and will close to new input on 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. The draft guidance documents Identifying and Labelling Medicinal Ingredients and Generic Drug Equivalence: Medicinal Ingredients outline the implementation of the regulatory proposal out for consultation in Canada Gazette I.

Join in: how to participate

  1. Read the proposed changes to the Food and Drug Regulations.
  2. Read the draft guidance documents: Identifying and Labelling Medicinal Ingredients; Generic Drug Equivalence: Medicinal Ingredients.
  3. To make yourself heard, send an email to Bureau of Policy, Science and International Programs at hc.policy.bureau.enquiries.sc@canada.ca with your ideas or comments.

Who is the focus of this consultation?

We will engage with:

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

Goals of the consultation

The goal of this consultation is 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 The draft guidance documents have been released to support the proposed regulatory amendments which seek to clarify the eligibility criteria of the Abbreviated New Drug Submission pathway used to approve certain generic drugs. 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 out for consultation in Canada Gazette I.

Related information

  • Canada Gazette Part I consultation Access to Generic Drugs

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

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