Applying Key Learnings From Health Canada PRCI to EMA’s Regulation EU CTR No. 536 and Policy 0070

We often receive questions from sponsors about Regulation EU No. 536 which is expected to take effect later in 2021. Common questions include, “What is included in the rollout?” “What is the scope of documents and data anonymization for EMA Reg 536?” “Will EMA Policy 0070 be superseded?” “What are the timelines?” “How do we prepare?”

EMA is completing testing and moving toward its launch of the CTIS (Clinical Trials Information System) in December 2021, thus triggering the requirement to comply with EU CTR (Clinical Trial Regulation) 536. There are key learnings from Health Canada PRCI that can be applied to help Sponsors prepare.

When Health Canada (HC) released PRCI in March 2019 a stronger emphasis on utilizing a risk-based anonymization process for clinical study reports effectively began. Some suggest that Health Canada’s launch of PRCI (Public Release of Clinical Information) placed HC ahead of the EMA in prioritizing quantitative anonymization standards that reached beyond a redaction only approach. In addition, HC was enforcing a phased rollout of the policy to which Sponsors were expected to comply.  

Health Canada PRCI and EMA Policy 70 in effect, allowed sponsors to prep for EMA Reg 536.  By establishing a base of best practices within efficient document and risk-based data anonymization processes, Sponsors are well suited to adapt to EMA Reg 536. This set of practices includes establishing internal processes, roles and responsibilities and adopting technology to aid in analysis and processing of the applicable data and documents.

It is also recognized that  Health Canada PRCI expectations continue to evolve.  It is not out of the realm of possibility to see Health Canada continue on its current trajectory and greatly reduce redaction as a methodology in most instances and place its full weight behind risk based anonymization techniques.  Would EMA then follow?

In working with a large and small sponsors and a wide range of therapeutic areas and study characteristics, one takeaway is apparent: taking the key learnings from HC PRCI and creating a tactical, actionable framework will position trial transparency teams ahead of the curve in terms of meeting a wider range of global regulatory policies.  For any organization to be successful, standardization is key.

The disclosure requirements  expected  by EMA Reg 536 can be effectively managed by utilizing data/document anonymization templates and standardized processes that have been assembled through experience with HC submissions and known regulator preferences.  Road tested anonymization techniques, multiple instances of successful pre-PIM preparation, approved report templates as well as extensive trial variable prioritization all provide a solid framework for EMA Reg 536 application and resumption of Policy 0070 activity.

We believe Health Canada PRCI, now in its second year, will continue to push clinical trial transparency further by seeking an increase in the number of submissions that employ risk based assessment techniques. More and more, we see notices on Health Canada’s clinical information database for recent decisions that underline HC’s emphasis on quantitative data transformation approaches. The notices begin:

“This clinical information package includes extensive redactions to the patient information and/or data listed below. These specific redactions do not conform to Health Canada guidance, which encourages manufacturers to retain the analytical value of information by using other transformation methods (e.g., generalization or randomization), and to apply these methods to specific information that risks reidentifying an individual rather than to redact broad sections of information.”

Based on the increased frequency of these Health Canada notices we can see a pattern emerge toward an increase in preference for risk-based data anonymization techniques.  We have seen this pattern quite clearly in our interactions with Health Canada on behalf of our Sponsor organizations.

Initially, the emphasis for the EMA will be to roll out the CTIS, ensure functionality beyond beta and activate EMA Reg 536.  It is then a conservative assumption, that as Policy 0070 activities resume it will be modified to follow the evolution of HC PRCI with   implementation of quantitative risk based practices.  Whether Policy 0070 is updated or rolled into the expanded scope of EMA Reg 536 the principles remain the same.

Based on what we have learned from Health Canada PRCI from processing multiple submission packages, undoubtedly there is a standard approach Sponsors can achieve that will result in successful submissions to both Health Canada PRCI and EMA Reg 536/Policy 0070 and its probable evolution. Note that Health Canada will already accept an approved EMA submission with reciprocity. More importantly Sponsors which choose to build a framework based on HC PRCI learnings and instituting repeatable automated processes stand to win. 


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