iThe European Medicines Agency (EMA) published Version 1.1 of its “Guidance on how to approach the safeguarding of personal protected data (“PPD”) and commercially confidential information (“CCI”) while using the Clinical Trials Information System (“CTIS”)” on July 10, 2023 (Guidance). The report closely adheres to the Draft of the Guidance that the EMA published on April 7, 2022.
The Guidance is a useful tool for Sponsors utilizing CTIS for clinical trial filings in the European Economic Area (EEA). The Guidance provides the most current recommendations from the EMA on what information within CTIS filings may be redacted as Confidential Commercial Information (CCI) by Sponsors, and what information must be redacted as Protected Personal Data (PPD) by Sponsors.
With respect to protection of CCI, the Guidance provides an overview regarding the availability and the use of the “deferral mechanism” as an alternative to redaction of CCI. When granted, the deferral mechanism delays publication of a set of data and certain documents (e.g., protocol, investigator brochure, or informed consent information sheet) for a certain number of months or years after the end of the trial in the EU/EEA or until the publication of the final summary of results. With limited exceptions, information filed within CTIS that is not deferred or redacted becomes publicly available at the time a decision is made regarding the application.
Sponsors should be aware that a deferral will impact the extent of information, if any, that may be redacted as CCI. The deferral mechanism is available to Sponsors for particular clinical studies depending on factors such as the study population and the phase of the study. The other option for protection of CCI is the targeted redaction of confidential information within documents. Regardless, Sponsors need to implement strategies for properly identifying what is and is not CCI, and the Guidance stresses the importance of consistency in redaction of CCI.
The Guidance also provides considerations for Sponsors regarding documents submitted “for publication” and “not for publication,” including anonymization and pseudonymization of PPD as it applies to those two document versions. The Guidance provides an overview of the principles of anonymization and pseudonymization, and the application of those principles for Sponsors in CTIS submissions. Sponsors should prepare anonymization and pseudonymization techniques that are compliant with the applicable provisions of the Clinical Trial Regulation (EU-CTR) and the General Data Protection Regulation (GDPR).
