April 16, 2017
Health Canada has released a white paper outlining its proposed initiative to make specified clinical information from drug submissions and medical device applications publicly available following the completion of its regulatory review process. The “Public release of clinical information in drug submissions and medical device applications” document was published online March 10, 2017. Details concerning the policy objectives, rationale, approach and future considerations are outlined in the posting.
The initiative is in response to Health Canada’s commitment to be transparent and open, and in recognition of the fact that access to clinical information can assist and benefit healthcare professionals, researchers and patients in a multitude of ways. Public access can help promote the appropriate use of drugs and medical devices, support Canadians to make better informed health decisions, avoid duplicative studies, and advance medical science. The ultimate rationale of this release is to increase access to timely, useful and credible clinical information, to improve patient safety and ultimately advance health outcomes for Canadians. Health Canada's proposed approach actually brings our country’s regulatory process in line with the policies of other regulatory bodies, including the European Medicines Agency and the US Food and Drugs Administration.
While Health Canada has proposed greater open access to clinical information overall, it is noted that certain categories of commercial information contained in drug submissions/device applications will be permitted to be exempted. Manufacturers will be provided with an opportunity to comment on exemptions for consideration by Health Canada prior to release of the clinical information.
Canadians have until May 26, 2017 to provide feedback on the proposed policy recommendations.
It remains to be seen exactly how public access to clinical information will impact the Regulatory and Medical Affairs activities of Canadian Pharmaceutical and Medical Device companies. One would expect greater demands on these functional areas both prior to the public release (as Manufacturers will be provided with an opportunity to comment on proposed exemptions/redactions) as well as after it. Following the release of clinical information, opportunities for those in Medical Affairs to interact with healthcare professionals and researchers may be expanded as these groups review the newly available material.
For the complete document regarding the public release of clinical information in drug submissions and medical device applications please click here. To access the Government of Canada’s Open Government portal please click here. For further details concerning Health Canada’s Regulatory Transparency and Openness Framework and Action Plan click here.
For more information, please contact Tina Laister, PhD, Director, The Pangaea Group