Notice: Availability of Summary Basis of Decision Documents and Regulatory Decision Summaries on the Drug and Health Product Register
March 29, 2017
Our file number: 17-103582-976
The Therapeutic Products Directorate and Biologics and Genetic Therapies Directorate of the Health Products and Food Branch have changed the location of the web postings of two key pre-market transparency initiatives. This is in line with the planned migration of content from the Health Canada website to the new Canada.ca site.
Drug and Health Product Register
Summary Basis of Decision documents (SBDs) and Regulatory Decision Summaries (RDSs) for pharmaceuticals, biologics, and medical devices are now available exclusively on the Canada.ca website through the Drug and Health Product Register (DHPR). The SBD postings on the DHPR also include the Post-Authorization Activity Tables (PAATs, for drugs) and Post-Licensing Activity Tables (PLATs, for devices) that accompany Phase II SBDs.
Click on 'Summary Reports' in the menu, and choose 'Summary Basis of Decision' or 'Regulatory Decision Summary' to search within either set of documents. Searches can be conducted by manufacturer, medicinal ingredient, drug or device name, drug identification number, or device licence number. Lists of all SBDs and all RDSs are available by clicking on links below the search fields.
Previously, SBDs and RDSs were hyperlinked from lists on the Health Canada website, by drugs and medical devices. As of the date of this Notice, these index pages will be removed from the Health Canada website.
What's New Pages and RSS Feeds
The "What's New" pages for pharmaceuticals, biologics and medical devices will continue to provide links to SBDs, PAATs/PLATs, and RDSs as they are published.
Health Canada's 'Drug Products' and 'Medical Devices' Really Simple Syndication (RSS) feeds will also provide links to SBDs, PAATs/PLATs, and RDSs as they are published. For more information, consult the Health Canada RSS feeds information page.
Notice of Compliance Database
Links to individual SBDs for drug products will no longer be provided from the Notice of Compliance (NOC) searchable database. Consideration may be given in the future to linking from individual NOCs to both SBDs and RDSs, where available.
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
Address Locator: 3106C
1600 Scott Street
Ottawa, Ontario K1A 0K9
Telephone: 613-941-1248
Facsimile: 613-957-1483
Email: OPPRS_enquiries@hc-sc.gc.ca