Clinical Trial Data Sharing Under EMA Policy 0070

This white paper discusses the European Medicines Agency's (EMA) Policy 0070, which mandates the public disclosure of clinical data for medicinal products in the European Union. The paper outlines the relaunch of this policy in September 2024 after a five-year pause due to BREXIT and the pandemic. It highlights the advancements in pharmaceutical transparency while ensuring the protection of personal and commercial data. The document details the introduction of an Anonymization Report template that aims to streamline data protection methodology disclosure. It also addresses the challenges faced in achieving the policy's goals, including the inconsistency in data treatment across studies. The paper presents Certara's strategies for improving the anonymization process and ensuring compliance with regulatory requirements. It concludes with an overview of the improvements in the submission process and the positive reception from stakeholders, emphasizing the importance of balancing data transparency with patient privacy.