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Health Canada Begins Release of Clinical Data on Drugs and Devices

Posted 14 March 2019 | By Ana Mulero 

Health Canada Begins Release of Clinical Data on Drugs and Devices

Health Canada launched two public databases on Wednesday as the first step in making clinical information about the safety and effectiveness of drugs and medical devices publicly available.

The drug and device databases currently display just one record for each: a notice of compliance issued to CSL Behring Canada in 2016 and an approval granted to Siemens Healthcare GmbH last December.

Following consultation on Health Canada’s plans to start making clinical information public, the agency finalized guidance from last April that sets the stage for how to implement its Public Release of Clinical Information (PRCI) initiative.

The 32-page guidance is intended to aid industry and others in understanding the procedures to follow in preparing clinical information for public release of the clinical data, the protection of personal information and the requirements for proposed redaction of confidential business information (CBI).

Health Canada said that it has “described limited and specific circumstances, prescribed in regulations, where information found within the clinical component of a drug submission or medical device application may possess ongoing commercial value following the final regulatory decision.” These circumstances set the eligibility criteria for industry to propose redactions of CBI in drug submissions.

The agency intends to specify the eligible CBI categories for medical devices in future guidance. Device applications in Canada are currently being revamped based on  the globally agreed upon Table of Contents (ToC) format, with implementation set to start in April. In the meantime, Health Canada said “device manufacturers should refer to Section 5 for guidance in proposing redactions consistent with the exceptions specified in the Medical Device Regulations section 43.12(2).”

The release of clinical information will be a phased-in process for different types of submissions and products throughout the next four years. For existing products, Health Canada also intends to release clinical information, upon request, through the agency’s clinical information portal.

For the proactive disclosure of clinical information, Health Canada will follow four implementation stages. The first two stages will only apply to certain drug submissions, whereas stages 3 and 4 will apply to the publication of Class III and IV medical device applications. The tables below detail the schedule to implement and apply the regulations, followed by the schedule for proactive disclosure by application type based on the four stages.

Application-and-implementation-(1).PNG

Proactive-disclosure.PNG

Categories: Regulatory News

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