Health Canada’s PRCI Process – A Deep Drive into Transparency

Transparency in the approval and regulation of health products is crucial for maintaining public trust, ensuring patient safety, and enabling informed decision-making. Health Canada has taken significant advances toward ensuring transparency in its drug approval process. One of the key initiatives in this effort is the Public Release of Clinical Information (PRCI) process. This process allows for the disclosure of anonymized clinical information in drug submissions for non-commercial purposes following the completion of Health Canada’s regulatory review process, while adhering to Canada’s Privacy Act. By releasing this information to the public, Health Canada is fostering a culture of transparency, accountability, and trust in the regulatory process.

The PRCI process is designed to strike a balance between transparency and the protection of sensitive information, such as confidential business information and detailed patient-level data. The process follows a clear set of guidelines to ensure that useful clinical trial data is made available to the public while safeguarding intellectual property rights of stakeholders. Once a drug has been approved or rejected, Health Canada collaborates with stakeholders through five distinct phases – PRCI process initiation, submission of proposed redactions package, Health Canada’s review of the proposed package, finalization, and publication. Health Canada aims to post the final redacted and anonymized clinical package online within 120 calendar days from initiation of the process. This includes Module 2 Clinical Summaries and Module 5 Clinical Study Reports of New Drug Submissions (NDS) and their Supplements (SNDS). The public release of clinical information in Abbreviated New Drug Submissions (ANDS) and their Supplements (SANDS) is on-request basis.

Health Canada’s commitment to transparency represents a significant step forward in building a more open, accountable, and trustworthy regulatory process. Through these efforts, Canadians can have greater confidence that the drugs they use are safe, effective, and backed by rigorous scientific evidence.

For more information on how Intrinsik can assist with Health Canada’s Public Release of Clinical Information, please contact: .