Health Canada has launched a new clinical information portal for drugs and medical devices which will be accessible to everybody. Let's take a tour of this new portal.
Health Canada has recently released a new clinical information portal that will provide Canadian consumers with easy access to the clinical information that is provided by manufacturers when submitting for approval of new drugs and medical devices. This includes clinical trials and study reports. Closer to the end of this article, you will find a video that walks you through the portal as it currently exists.
Currently, the site only has 1 drug and 1 medical device as part of the listing, but Health Canada is planning on including the clinical trials and study reports of new drugs 120 days (3 months) after the approval of their new drug submission. Proactive disclosure for medical devices will start in 2021.
With regards to existing drugs and medical devices, my understanding is that Health Canada will provide the clinical trial information upon request and will also add them to the portal as the requests roll in.
It’s clear what this means for consumers – they will have access to highly credible data sources related to their prescription drugs and the medical devices that are used as part of their diagnosis or treatment. This is a good thing, particularly since Canadians are bombarded by U.S. prescription drug ads which give a bunch of clinical information anyways.
But what does this mean for companies that market drugs and medical devices in Canada?
Should companies start to expect more or fewer medical inquiries? My personal guess is that it will increase overall but not by all that much because some consumers will find the information that they were looking for by themselves and will not need to contact the company. Otherwise may have even more questions after reading the documents. Let’s face it – supporting articles for drug product and medical device submissions are loaded with heavy-duty medical and pharmacological information. They will answer some questions and will definitely end up creating new ones as well. But questions about one’s health are good. We want and need our Canadian consumers to be well informed about their health so that they can make better decisions and choices for themselves and the ones they care for.
There might be more transparency about competitive launch dates based on the list of drugs or medical devices that are accessible to all. Market researchers and analysts already keep track of various competitive data, but this will be one more aspect to provide more
Once the database is more mature and robust, it will contain a lot of information. This will become pertinent for global pharmaceutical companies looking for sales opportunities in Canada. Before they launch or look for partners, they will be able to easily scope out the landscape in terms competitive activity.
Transparency and accuracy are critical in the era of digital information, so Health Canada made the right decision in moving in this direction, even though some will certainly disagree.
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