Consultation on a proposed interim approach to speed up the review of certain pediatric drugs

We're proposing a new interim approach to speed up the review of certain pediatric drugs. Under this new approach, we plan to review certain pediatric drug submissions within 180 days.

Join in: how to participate

We're consulting with manufacturers and other interested parties on a proposed interim approach for certain pediatric drug submissions. We will use the feedback we receive to refine this proposed interim approach.

Send us an email

Send an email to policy_bureau_enquiries@hc-sc.gc.ca with your ideas or comments. In the subject line of the email, use "Comments on a proposed interim approach to speed up the review of certain pediatric drugs".

Who is the focus of this consultation

We will engage with:

• industry
• health care professionals

Key questions for discussion

Through this consultation, Health Canada is seeking feedback on:

• proposed eligibility criteria and review timelines
• any other general suggestions or questions for us to consider

Related information

• Proposed interim approach to speed up the review of certain pediatric drugs: Notice
• Guidance for industry - Priority review of drug submissions
• Guidance Document: Notice of compliance with conditions (NOC/c)
• Guidance on management of drug submissions and applications

Contact us

Bureau of Policy, Science and International Programs
Pharmaceutical Drugs Directorate
Health Products and Food Branch
Health Canada
Email: policy_bureau_enquiries@hc-sc.gc.ca

From: Health Canada