Health Canada is launching a number of new initiatives to improve the transparency and availability of health product and other regulatory information. These initiatives build on the progress already made with other Health Canada transparency measures achieved through its Regulatory Transparency and Openness Framework. Under the Framework, Health Canada is making more regulatory information available and easier to access than ever before, to aid Canadians in health and safety decisions for themselves and their families.
Drug and Health Product Register
Health Canada makes a wealth of information available online but it&'s not always easy to find or understand. The Drug and Health Product Register (DHPR) brings together and organizes health product information drawn from various areas and databases on Health Canada's website and presents the information in a centralized, easy-to-find, easy-to-use way.
Consumers and health professionals can access practical health product safety information including what a drug is used for, safety warnings and common side effects. They can also see what adverse reactions have been reported to Health Canada, and report a side effect quickly and securely using the online application. In this initial phase, the DHPR includes entries for about 350 prescription medications, including the top 100 prescribed drugs and biologics in Canada. Health Canada will continue to populate and build on the DHPR over time.
The new site is mobile-friendly, so Canadians can access health product information on the go. Canadians are invited to provide feedback on their experience using the new register and on ways to improve it.
The Health Product InfoWatch
Health Canada is improving the way it makes health product information available to health professionals with the Health Product InfoWatch, a new monthly publication that will expand on and replace the longstanding quarterly Canadian Adverse Reaction Newsletter (CARN). The Health Product InfoWatch continues the CARN tradition of providing credible information on potential safety issues detected through the review of case reports submitted to Health Canada, but it will be published more frequently and will cover a broader range of safety information, to meet the changing information needs of healthcare professionals. Subscribe to receive a copy by e-mail or RSS.
List of New Health Product Safety Reviews
The list of new health product safety reviews provides early notice that Health Canada is evaluating a possible new safety concern involving a health product available in Canada. It builds on information Health Canada already publishes in its summaries of completed safety reviews. With the list, Canadians can know that Health Canada is assessing a possible risk early in the process, before the review is complete. The list of reviews and the summaries of completed reviews complement other safety-related information to help Canadians make informed medication choices. The initial list includes 21 safety reviews started between July and December 2014. New safety reviews will be added to the list each quarter.
Paediatric Product Listing
The list of drug products that have paediatric information on their labels gives prescribers and caregivers easier access to this information in one central location. It includes prescription drugs and biologics - including vaccines - that are authorized for use in children and/or that include information about paediatric safety or effectiveness in their labelling. The initial paediatric product table includes listings for 278 prescription medications and biologics. It will be updated periodically as new data becomes available.
Interim Report on the Regulatory Transparency and Openness Framework and Action Plan
Health Canada has posted an Interim Report on the Framework that provides an update on the Department's progress in achieving commitments it set out to deliver by March 31, 2015 for greater regulatory transparency and openness with Canadians. The report highlights important accomplishments in the first six months of the Action Plan and how the Department is delivering above and beyond its original commitments - including setting three new commitments that it will complete by March 31, 2015.
