Consultation: proposals for prescription drug transparency

From Health Canada

Current status: The public consultation is now closed. Thank you for your interest.

You're invited to comment on proposals to increase pre-market transparency related to human prescription drugs.

Why

Having more information and transparency about government decisions could mean:

• increasing knowledge about prescription drug products to help inform treatment choices
• being better informed to allow more meaningful participation in engagement activities
• increasing the clarity of regulatory decisions for industry, which may help to inform future submissions
• improving information sharing and relationship building between Canadians and industry

Please tell us what other potential impacts and benefits these proposals may have for you or your work.

Who

We are seeking input from all Canadians who are interested in transparency measures related to human prescription drug products, including:

• patients and caregivers
• patient groups and associations
• health care providers and their associations
• Canadian provincial and territorial governments
• academics and researchers in the areas of prescription drugs including:
  • biological products
  • pharmaceuticals
• pharmaceutical and biotechnology industry members and industry associations
• other non-government organizations

What

We are seeking your input on 5 proposals for pre-market transparency initiatives for human prescription drugs. These are:

• publishing a summary explaining our decision on certain prescription generic drug submissions
• publishing a list of prescription generic drug submissions sent to Health Canada for review
• expanding the scope of the current Regulatory Decision Summary initiative to include more drug submissions
• adding company (sponsor) names to entries on the Submissions Under Review (SUR) List
• adding the submission ‘class’ to entries on the SUR List

More details on the proposals can be found in the consultation document.

When and where

This consultation is available online between September 28, 2017, and October 28, 2017.

How to Participate

Please read the consultation document and submit feedback only through the consultation document directly.

Do not submit comments by email.

All comments received by October 28, 2017 will be considered in our decision-making about the design and implementation of transparency measures.

For more information

Attention: Transparency Consultation
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: Policy_Bureau_Enquiries@hc-sc.gc.ca