Understanding PRCI and Its Requirements

What is PRCI and what are Health Canada’s objectives?

Public Release of Clinical Information (PRCI) is Health Canada’s initiative to release clinical information from drug submissions and medical device applications to the public. The goal of PRCI is to enable independent analysis of safety and efficacy results while increasing transparency in the drug and medical device regulatory review process. Before clinical data is posted to the public Clinical Information Portal, it must be anonymized to protect personal health information and confidential business information. PRCI is a 120-day collaborative process between Health Canada and the sponsor to agree on what information can be protected from public disclosure.

What are the PRCI requirements?

The process begins on the date Health Canada issues the Notice of Decision. From that point:

Sponsors have 60 days to review all in-scope clinical documents, propose information that requires protection, and provide justification for the redactions.
Health Canada then has 30 days to review the proposed redactions and either accept or reject them.
Sponsors can provide further justifications or modifications within 15 days in the Second Draft PRCI package, which Health Canada will review again.
The sponsor then finalizes the process by submitting the final PRCI package within 5 days.

How Innomar supports

Navigating the PRCI process can be challenging, but at Innomar, we have in-depth experience in reviewing, preparing, and submitting PRCI packages enabling comprehensive PRCI services from start to finish. Since the program’s inception in 2019, we have been actively involved in preparing and submitting PRCI packages, including:

Anonymization Reports: Ensuring PHI and CBI are protected while maintaining transparency.
Proposed Redaction Control Sheets: Managing redaction requests with clear justifications.
End-to-End Support: Overseeing the full PRCI process, from initial review to final submission.

Our team understands the complexities of PRCI and can provide reliable guidance and comprehensive services tailored to your needs. Reach out to Innomar today to learn more about how we can support your PRCI needs and ensure you’re prepared for Health Canada’s requirements.

The information provided in this piece does not constitute legal or medical advice. Innomar Strategies Inc. and its parent Cencora, Inc. strongly encourage the audience to review available information related to the topics discussed to rely on their own experience and expertise in making decisions related thereto. Further, the contents of this piece are owned by Innomar Strategies, and reproduction is not permitted without the consent of Innomar Strategies.