Health Canada released guidance on March 12, 2019 pertaining to its Public Release of Clinical Information (PRCI) initiative. Health Canada’s objective with this initiative is to make anonymized clinical information in drug submissions and medical device applications publicly available for non-commercial purposes to enable re-analyses of data, foster new research questions, and help Canadians to make more informed decisions regarding their health.
Following is a summary of the PRCI guidance, including which past drug submissions and medical device applications for which clinical information may be requested; procedures to prepare information for release; and the implementation schedule for proactive disclosure.
Health Canada Public Release of Clinical Information
On-Request Release of Clinical Information in Past Drug Submissions and Medical Device Applications
Effective March 20, 2019 clinical information from the following past drug submissions and medical device applications may be requested through Health Canada’s clinical information portal:
- New Drug Submissions (NDS)
- Supplemental New Drug Submissions (SNDS)
- Abbreviated New Drug Submissions (ANDS)
- Supplemental Abbreviated New Drug Submissions (SANDS)
- Extraordinary Use New Drug Submissions (EUNDS)
- Supplemental Extraordinary Use New Drug Submissions (SEUNDS)
- Class III – IV Medical Device Applications and Amendments
Procedures for Clinical Information in Drug Submissions and Medical Device Applications
Health Canada aims to upload a final redacted and anonymized clinical information package to its portal within 120 days from initiation of the process.
The publication of clinical information under the PRCI initiative proceeds through five phases:
Prior to the initiation of the publication of clinical information, Sponsors may elect to attend a one-on-one process initiation meeting (PIM). Sponsors new to the initiative are encouraged to request a PIM prior to starting the process. See section 4.1 of the guidance for instructions on how to request a PIM.
Submission of the redaction proposal package must include annotated documents with proposed confidential business information (CBI) redactions and anonymization according to the process outlined in section 5 of the guidance. The process of data anonymization should be detailed in a separate Anonymization report.
Health Canada will review the justifications for each proposed redaction within the annotated documents. Following review, proposed redactions will be accepted or rejected prior to finalization of the clinical information for public release.
Following review, Sponsors must submit a final version of the documents, according to Health Canada instructions found in section 4.6 of the guidance.
Final documents will be made publicly available for non-commercial purposes through Health Canada’s clinical information portal.
Implementation Schedule for Proactive Disclosure
Health Canada plans to phase-in the proactive release of clinical information in new drug submissions and medical device applications. Proactive publication of this information is expected to be implemented according to the following schedule.
- 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)
- Rx-switch (full and partial submissions to switch an authorized medicinal ingredient to non-prescription status)
- New drug submissions (both NDS-NAS and those not categorized as new active substances.)
- Supplemental new drug submissions (SNDS)
- Class IV medical device applications
- Abbreviated new drug submissions (ANDS)
- Class III medical device applications
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