Over seven years ago, the Management Board of the European Medicines Agency (EMA) adopted Policy 0070, a requirement to publish anonymized versions of clinical study reports (CSRs) and other regulatory submission documents. In December 2018, EMA enacted their business continuity plan, which meant publication of clinical data was put on hold. A limited return of this requirement was enacted for COVID-19 treatments and vaccines starting mid-2020; with Regulation EU No. 536/2014, publication of all information submitted to the Clinical Trial Information System (CTIS) paves the way for a full return of this policy in early 2022.
In parallel, Health Canada’s (HC) Public Release of Clinical Information initiative went into effect three years ago, requiring the release of anonymized clinical information in drug submissions and medical device applications adhering to Canada’s Privacy Act. The agency’s desire is that publicly accessible clinical information will enable independent re-analyses of data, will garner further research, and will benefit Canadian citizens in making sound health decisions.
Though both agencies share a similar approach with minor deviations between their respective policies, there are specific differences such as medical histories information in patient safety narratives and bioanalytical reports that are in scope for HC and are based on data on any patient within the study results. With deviances such as this, an anonymized package for one agency may not be accepted by the other, and the Sponsor will incur the costs of compliance for each without any leeway in preparation or processes.
Canada and Europe Partner to Promote Data Transparency
Although HC and EMA are separated in practice and geography, we have seen a more recent emphasis on partnership regarding data transparency. During the COVID-19 pandemic, EMA and HC wanted to demonstrate their support for openness and building confidence for the public by jointly reviewing and publishing the clinical trial data for the Moderna vaccine. Both agencies also publicly disclosed their initiative to align their definitions of Company Confidential Information (CCI) and took a common approach for managing the anonymization of Protected Personal Data (PPD).
What we know so far is HC’s anonymization guidance follows the same principles as the EMA’s, and HC will accept documents already anonymized according to the EMA’s recommended methodology. If the Sponsor has or may submit its marketing/interim application to HC as well, EMA’s publication of clinical data requests often contain the proposal to run the entire process in collaboration with HC. This would align the requirements and synchronize the publication.
What impact does this partnership have on you when an EMA or HC request is received?
- Avoid re-work/re-processing, resulting in additional costs – anonymize/redact the requested report only once, with recyclability for submission to EMA and HC
- Streamline communication from the start, freeing up resources to manage other submission tasks – avoid duplicate conversations with both agencies and your transparency and disclosure vendor
- Ensure your approach will be accepted by both agencies – engage with your Transparency and Disclosure vendor in a single process from proposal to final submission package
- Promote confidence in the ability to meet timelines – feel at ease with meeting the required timelines for submission
Direct coordination between the requestors, or Document Coordinators, at both EMA and HC would further streamline redacting sensitive PPD or transforming data related to rare disease/patient populations. Efforts to improve the efficiency of data sharing initiatives should also be considered on multiregional levels, especially standardizing qualitative and quantitative transformations for CCI and PPD.
Certara Synchrogenix can be your next partner for all your transparency and disclosure needs as a leading technology and services provider. Our years of experience in successfully supporting programs across regions, as well as our exclusive team of experts, are primed to help you meet and exceed your compliance requirements. Click below to learn more and to contact us.