Notice: Regulatory Decision Summaries and Submissions Under Review

March 13, 2015
Our file number: 15-103061-39

Increasing transparency

The Health Products and Food Branch (HPFB) of Health Canada is pleased to announce the phasing in of online publication of Regulatory Decision Summaries and a list of Submissions Under Review. This project is part of HPFB's ongoing commitments to enhance the transparency of the pharmaceutical, biologic and medical device regulatory review processes, and to provide access to information about Health Canada's decisions to authorize these products for sale in Canada.

Background

The Government of Canada is making more data and information available to Canadians than ever before. Canadians are also being offered more opportunities to participate in discussions on government policies and priorities.

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 transparency initiatives described in this Notice will apply to medical devices and prescription drugs (pharmaceuticals and biologics) only in this initial phase. At this time, work to develop the Consumer Health Products Framework is underway. Initiatives related to transparency and communicating rationales for decisions for consumer health products (including non-prescription drugs and natural health products) will be developed in conjunction with the new framework.

Submissions Under Review

Health Canada will be informing Canadians, through a phased approach on the Canada.ca website, of new drug submissions (NDS) for new active substances (NAS) for both pharmaceuticals and biologics that are accepted into review on or after April 1^st, 2015. (New Active Substances are defined in the Fees in Respect of Drugs and Medical Devices Regulations.)

Health Canada will publish a list of these submissions that will include the medicinal ingredient(s) and therapeutic class. The list of Submissions Under Review will be updated monthly. Once a final decision is rendered, the submission will be removed from the list, as it is no longer under review.

The following year, the list will be expanded to include all NDSs and Supplemental New Drug Submissions (SNDS) for new indications accepted into review on or after April 1st, 2016.

Regulatory Decision Summaries

Health Canada will also increase information currently made available on regulatory decisions for health products seeking authorization through a phased approach. Health Canada will begin posting Regulatory Decision Summaries for certain market authorization decisions.

The posting of Regulatory Decision Summaries will be phased in, beginning April 1^st, 2015:

• Decisions issued after April 1st, 2015: Posting Regulatory Decision Summaries for positive decisions for NDSs and SNDSs for new indications and positive decisions for new Class IV medical device applications.

• Submissions accepted into review on or after April 1st, 2015: Posting Regulatory Decision Summaries for final negative decisions and cancellations for NDSs for NASs.

• Submissions accepted into review on or after April 1st, 2016: Posting Regulatory Decision Summaries for final negative decisions and cancellations for all NDSs, SNDSs for new indications and new Class IV medical device applications.

Regulatory Decisions Summaries are Health Canada documents that are intended to communicate the rationale for Health Canada's decisions. The documents have been designed to convey the purpose of the submission and the reason for the decision that was issued. The primary document for product information for drugs remains the Product Monograph, and for medical devices, the product labelling including User Manual and/or Instructions for Use.

Regulatory Decision Summaries will complement a continuum of transparency and openness initiatives including the Submissions Under Review list and Summary Basis of Decision (SBD) documents. Health Canada will continue to publish SBD documents as described in the launch of Phase II of the SBD initiative. The scope of SBD-eligible products includes positive decisions for NDSs for NASs and subsequent entry biologics, and a subset of licensed Class III or IV devices with novel technology. Post-Authorization Activity Tables (drugs) and Post-Licensing Activity Tables (devices) will continue to be published, providing important information beyond the product's initial authorization.

Where to find more information

For more information about the Regulatory Transparency and Openness initiatives at Health Canada, please refer to the Health Canada website.

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