Notice: Regulatory Decision Summaries and the Submissions Under Review List

March 18, 2016
Our file number: 16-103113-647

Transparency Initiatives Phase II

As of May 1, 2016 the Health Products and Food Branch (HPFB) will be proceeding with Phase II of the Regulatory Decision Summary (RDS) and Submissions Under Review (SUR) List initiatives.

RDS will now be prepared and posted for the following:

• Phase I: Decisions issued after April 1st, 2015: Positive decisions for New Drug Submissions (NDSs) and Supplemental New Drug Submissions (SNDSs) for new indications and positive decisions for new Class IV medical device applications.
• Phase I: Submissions accepted into review on or after April 1st, 2015: Final negative decisions and cancellations for NDSs for New Active Substances (NASs).
• Phase II: Submissions accepted into review on or after May 1st, 2016: Final negative decisions and cancellations for all NDSs, SNDSs for new indications and new Class IV medical device applications.

The following will now be included on the SUR List:

• Phase I: Medicinal ingredient and therapeutic class for NDSs for NASs for pharmaceuticals and biologics accepted into review on or after April1st, 2015.
• Phase II: Medicinal ingredient and therapeutic class for all NDSs and SNDSs for new indications for pharmaceuticals and biologics accepted into review on or after May 1st, 2016.

Background

As a regulator, Health Canada plays an important role in protecting the health and safety of Canadians. Greater transparency and openness with Canadians strengthens the trust in our regulatory decisions. The Regulatory Transparency and Openness Framework for Health Canada supports our commitment to the Government's overall Open Government initiative. This will ultimately support Canadians in making better decisions about their health.

The RDS initiative and the SUR List initiative were launched in 2015 as part of HPFB’s ongoing commitment to enhance the transparency of the pharmaceutical, biologic and medical device regulatory review processes. For more information about the launch of these initiatives, please see the Notice released on March 13, 2015.

HPFB held consultations on various health product transparency initiatives with stakeholders in January and February of 2016. Based upon the results of this consultation, HPFB will be moving forward with the planned Phase II of the RDS and SUR List initiatives, with a revised implementation date. HFPB will continue to analyze the results of the consultations in order to plan for a potential Phase III of the RDS, SUR List, and Summary Basis of Decision initiatives. A final report will be made available from this consultation.

Where to find more information

• Information on the RDS initiative
• Information on the SUR List initiative

Any comments regarding the above Notice should be directed to:

Office of Planning, Performance and Review Services (OPPRS)
Therapeutic Products Directorate
Health Products and Food Branch
Address Locator: 3002C
Health Canada
Ottawa, Ontario
K1A 0K9
E-mail: OPPRS_enquiries@hc-sc.gc.ca
Telephone: 613-941-1248
Fax: 613-957-1483