Clinical Trial Data Sharing Under EMA Policy 0070

The landscape for clinical trial data sharing is evolving rapidly. European Medicines Agency’s (EMA) Policy 0070 requires sponsors to publicly disclose clinical data for medicinal products in the European Union. It was suspended after Brexit and the COVID-19 pandemic. With the 2023 Policy 0070 relaunch, pharmaceutical companies face new challenges and opportunities in data transparency and disclosure.

Policy 0070 is more than a guideline; it’s a commitment to public trust through transparency in clinical trials. Changes are in motion, including:

Phase Expansion: Step 2 begins May 2025, widening the scope to include new application types.
Enhanced Anonymization: Improved EMA guidance ensures data protection while limiting unnecessary redactions.
Global Alignment: EMA is collaborating with Health Canada to streamline submission processes and reduce duplicate efforts.

What you’ll learn

Key Changes from Policy 0070 Part 1 to Part 2

Balancing Redaction and Transformation Techniques and determine the best approach for your datasets

Strategies for Managing Commercially Confidential Information (CCI)

Understanding Procedural Timelines and Pre-Submission Opportunities

Harmonizing Submissions Across Regulatory Bodies

Best Practices for Cross-Functional Collaboration

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About the author

Honz Slipka

Senior Transparency Specialist

With a research background in neuroscience, and experience in health information technology, Honz Slipka has a thorough understanding of data analysis, regulatory standards, and best practices in the field of clinical data privacy. Drawing from his experiences, Honz is a champion of innovation, helping to lead the field of science, healthcare, and research into the modern age of technological efficiency, clinical transparency, and data utility.

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About Certara

Certara is dedicated to transforming drug discovery and development for good. We harness the power of biosimulation, advanced analytics, and regulatory expertise to create a future where treatments reach patients faster and more efficiently.

From discovery to market access and commercial, we tailor solutions to meet our clients’ most pressing challenges. Through strategic leadership and advanced predictive technologies, Certara provides comprehensive solutions to optimize drug development processes, reduce risks, and improve outcomes. Our clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries.