The More We Know, The Better: The Benefits Of EMA Policy 70

By Anne Louise Kirkegaard, Director, Regulatory Affairs & Medical Writing, Pharma IT

The European Medicines Agency (EMA) Policy 70 significantly expands the requirement for publishing clinical data submitted for regulatory approval within the EU, fostering greater public trust and transparency. Since April 2025, the policy covers not only initial marketing authorization applications but also line extensions, major clinical Type II variations, and even applications that result in negative or withdrawn opinions. Understanding this broadened scope is critical, as virtually all clinical reports, including clinical study reports and summaries, are now subject to publication.

Achieving compliance presents a challenge: striking the right balance in the Redaction Proposal Document Package (RPDP). Over-redacting risks regulatory pushback and a loss of public trust, potentially delaying market access. Conversely, under-redacting can lead to patient privacy breaches, exposure of trade secrets, and non-compliance with data protection laws like GDPR. Starting the strategic compliance process early, even at the clinical trial protocol stage, is essential to mitigate these risks and ensure timely submission. Discover more about navigating these complexities and turning compliance into a strategic advantage.