On December 16, 2025, the EU Commission unveiled its proposal for the Biotech Act. The proposal, which is only the first part of a bigger initiative for regulating biotechnologies, focuses primarily on the health sector. The Commission took the opportunity to broadly revise the Clinical Trial Regulation (“CTR”) – see our blog post here. In particular, it sought to better align the CTR requirements with those of the General Data Protection Regulation (“GDPR”). This blog post provides an overview of those revisions relating to the processing of personal data during clinical trials.
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European Data Protection Board Answers Commission’s Questions on Health Research
Posted in EU Data Protection, Health Privacy
On February 2, 2021, the European Data Protection Board (“Board”) responded to questions submitted by the European Commission (“Commission”) on the application of the General Data Protection Regulation (“GDPR”) to health research. The Board also announced that it is currently working on guidelines on the processing of personal data for scientific research purposes, which it aims to publish in the course of 2021.
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European Commission Issues Updated Q&A on Interplay between the GDPR and the Clinical Trials Regulation
By Kristof Van Quathem & Dan Cooper on
Posted in European Union, Health Privacy
On April 10, 2019, European Commission Directorate-General for Health and Food Safety issued a revised Q&A analyzing the interplay between the EU Clinical Trials Regulation (“CTR”) and the EU General Data Protection Regulation (“GDPR”). The revised Q&A takes into account the opinion of the European Data Protection Board (“EDPB”) issued…
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European Data Protection Board releases Guidance on Intersection of the GDPR and the Clinical Trials Regulation
By Kristof Van Quathem on
The European Data Protection Board (“Board”) released an opinion on January 23, 2019, on the intersection between the EU General Data Protection Regulation (“GDPR”) and the Clinical Trials Regulation (“CTR”). The opinion considers a Q&A on this topic prepared by the European Commission’s Directorate General for Health. The Directorate General…
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