Consultation Notice: Health Canada Requests Feedback on Potential Impacts and Uses if Company Names were added to the Generic Submissions Under Review List

January 7, 2019
Our file number: 18-121970-181

As a regulator, Health Canada plays an important role in protecting the health and safety of Canadians. Health Canada is committed to being transparent and open about its activities and to making timely and useful information available about health product submissions.

To support the Department's commitment, the Health Products and Food Branch (HPFB) implements pre-market transparency initiatives related to prescription drugs (pharmaceuticals and biologics). This includes the Submissions Under Review (SUR) List. Phase I of the SUR List was launched in 2015 and Phase II in 2016. In August 2018, HPFB published a Notice announcing Phase III.

With the implementation of Phase III, HPFB now includes the name of the sponsor (the company that filed the submission) on the list of new drug submissions and supplements for new uses currently under review.

Phase III also included the launch of a new list of Abbreviated New Drug Submissions (ANDSs) (generic submissions) that were accepted into review on or after October 1, 2018. This list is called the Generic Submissions Under Review List and includes the medicinal ingredient(s), therapeutic area, and number of submissions. Similar to the first phases of the SUR Lists for New Drug Submissions and Supplemental New Drug Submissions for new uses, the new Generics Submissions under Review List does not include the name of the sponsor (company) that filed the ANDS. 

Health Canada is now seeking feedback on possible impacts and uses to stakeholders if sponsor (company) names were to be added to the Generic Submissions Under Review List. In providing feedback, the following information would be helpful:

1. Which of the following best describes you?
   1. General Public
   2. Patient/Caregiver
   3. Patient Group/Association
   4. Consumer Group
   5. Health Professional
   6. Health Professional Association
   7. Researcher/Academia
   8. Canadian federal/provincial/territorial government
   9. Pharmaceutical Industry – mainly generic products
   10. Pharmaceutical Industry – mainly innovator products
   11. Pharmaceutical Industry – multiple types of products
   12. Biotechnology Industry
   13. Medical Device Industry
   14. Industry Association
   15. Other (Please specify)
2. What would be the potential impact on you or your organization if the name of the sponsor (the company that filed the ANDS) were to be added to the Generic Submissions Under Review List?
3. Would knowing the name of the sponsor be useful to you?
   1. If yes, how would you use this information?
   2. If no, please explain why this information would not be useful.

Please provide feedback by email to hc.opprs.enquiries-enquettes.bprse.sc@canada.ca by February 8, 2019.

Comments or questions should be directed to the Office of Planning, Performance and Review Services.

Office of Planning, Performance and Review Services
Therapeutic Products Directorate
Health Canada
1600 Scott Street, 6^th floor
Ottawa, ON K1A 0K9

Telephone: 613-941-1248
Facsimile: 613-957-1483
Email: hc.opprs.enquiries-enquetes.bprse.sc@canada.ca