Last week, on March 13, 2019, Health Canada launched two public databases as the first step in making clinical information about drug and device safety and effectiveness publicly available. While each database currently only displays one record for each (Afstyla for the drug database and a device known as Mammomat Revelation on the device database), more data is expected to be uploaded in short order.
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.
The phasing-in process is expected to have four implementation stages. The first two stages will apply only to certain drug submissions and stages 3 and 4 will apply to the publication of Class III and Class IV medical device applications.
New submissions and applications for drugs are expected to begin proactive publication this year (2019), whereas new submissions and applications for medical devices are expected to begin proactive publication in 2021.
Timeline
In 2019, clinical information within drug submissions will be published for the following submissions: new active substances (NDS-NAS), representing submissions for drugs that are not variations of previously approved medicinal ingredients in Canada; supplemental new drug submissions containing confirmatory trials (SNDS-c), following the issuance of a notice of compliance with conditions as agreed to in the Letter of Undertaking; and submissions to switch an authorized medicinal ingredient to non-prescription status.
In 2020, on top of the previous published types, Health Canada plans to add the proactive publication of clinical information within all new drug submissions, both NDS-NAS and those that are not categorized as new active substances.
In 2021, Health Canada intends on adding the proactive publication of clinical information within all new supplemental drug submissions and in-scope clinical information within Class IV medical device applications.
In 2022, Health Canada plans to add the proactive publication of clinical information from abbreviated new drug submissions and from Class III medical device applications.
Guidance
In April 2018, Health Canada finalized guidance that outlines how the implementation of this initiative is to be completed. It includes information and 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).
In the future, Health Canada intends to specify the eligible CBI categories for medical devices. Currently, device applications in Canada are being revised based on the globally agreed upon Table of Contents 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).”
Individual Patient Records
Individual patient records and clinical case report forms typically represent a large portion of a typical drug submission, and therefore, because of the personal information included, require extensive modification to anonymize the information. However, researchers may be able to obtain that individualized patient record information for purposes of research or statistical analysis by submitting a request under the Privacy Act.