Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.
June 29, 2012
Our file number: 12-111627-755
The Health Products and Food Branch (HPFB) of Health Canada is pleased to announce the launch of Phase II of the Summary Basis of Decision (SBD) project. 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.
The first Phase of the SBD project started on January 1, 2005; since then, over 200 SBD documents have been posted on the Health Canada website. In 2008-09, Health Canada conducted an evaluation of the first Phase of the SBD project, which was followed by an internal analysis and proposals for Phase II. These proposals were the subject of internal and external consultations in 2011; in addition, the intent to launch Phase II was communicated to stakeholders in a variety of external meetings including the Canadian Drug Information Association meeting in November, 2011. The HPFB has now analysed the results of internal and external consultations, as well as the recommendations of the Office of the Auditor General which were communicated in Chapter 4 of the Fall 2011 Report entitled "Regulating Pharmaceutical Drugs" and is pleased to announce details of the launch of Phase II.
Phase II will launch effective immediately, with the publication of this notice and the accompanying:
The technical writers who are responsible for SBD drafting within HPFB will begin to implement a number of process improvements aimed at reducing the time to publication of the SBDs. The technical writers will draft Phase II SBDs for all eligible drugs and medical devices authorized/licensed as of September 1, 2012; for eligible products authorized before September 1, 2012, but on or after January 1, 2005, Phase I SBDs will be drafted.
The SBD will remain a document focussed on communicating the scientific rationale for Health Canada's decision to authorize the sale of an eligible product. Readers are reminded that the primary document for product information on drugs remains the Product Monograph, and for medical devices, the product labelling including User Manual and/or Instructions for Use.
With Phase II, the documents have been redesigned into a question and answer format; they will be streamlined, with an increased focus on Health Canada's risk/benefit analysis, and the Notice of Decision will be eliminated. The scope of SBD-eligible products will change only slightly for drugs, to include Subsequent Entry biologics and to remove hard surface disinfectants and new salts for existing products. For medical devices, the scope will change to include a selection of Category III or IV devices with novel technology.
One of the most significant changes for Phase II involves the publication of a Post-Authorization Activity Table (PAAT, for drugs) or Post-Licensing Activity Table (PLAT, for devices). These tables will provide important information beyond the product's authorization. The PAATs and PLATs will include brief summaries (normally one paragraph long) of such activities as submissions or applications for new uses of the product, and whether Health Canada's decision was negative or positive. This information is consistent with international trends and is connected to safe and effective use of the products.
Recognizing that the SBDs are Health Canada documents and are intended to reflect the regulatory review, it is acknowledged that the documents will complement (but likely will not match exactly) some of the information found in the Product Monograph or User's Manual. As further recognition of the nature and intent of the SBDs, feedback will continue to be sought from drug submission sponsors and medical device manufactures during the preparation of SBDs, but will be limited to inaccuracies of data only. It is expected that only minor revisions, if any, will be made to the document as a result of industry feedback received. As such, for Phase II, it has been determined that the appeal process available under Phase I will no longer be applied.
For more information about the changes to the SBD project with the launch of Phase II, please refer to the Frequently Asked Questions document.
Additional information will be posted on the Health Canada website during the summer, including Phase II SBD templates for drugs and devices, and further details about the Phase II SBD process.
Any comments regarding the above Notice should be directed to
Bureau of Policy, Science and International Programs,
Therapeutic Products Directorate,
1600 Scott Street,
Holland Cross, Tower 'B',
2nd Floor, Address Locator 3102C5,