During 2024 and 2025, several important updates to EMA transparency policies have come into effect, notably under the EU Clinical Trials Regulation (EU CTR) and the reactivation of Policy 0070. In our latest blog, Senior Regulatory and Medical Writer, Laura Erwin, explains more.
The European Medicines Agency (EMA) has set the tone for how clinical trial data is made accessible while balancing the protection of personal data and commercially confidential information. As regulatory expectations evolve, sponsors, researchers, and medical writers must adapt quickly to remain compliant and efficient.
EU Clinical Trials Regulation (EU CTR)
The EU CTR continues to mature in its implementation. The updated transparency regulations for the CTIS came into effect between 2024-2025. These revised rules aim to balance the need for public access to clinical trial information with the safeguarding of commercially confidential information (CCI). In addition, a major change introduced by the new rules is the removal of the deferral mechanism, which previously permitted sponsors to postpone the publication of certain documents and data for up to seven years following trial completion to protect CCI. However, certain documents, like the IB, which could include pseudonymised data of trial participants, are now usually excluded from publishing.
Policy 0070
The EMA’s Policy 0070, which focuses on the proactive publication of clinical data submitted in Marketing Authorisation Applications (MAAs), has been revived after its pandemic-related pause. Under the EMA framework, sponsors must publish a variety of documents including the clinical overview, the clinical summary, clinical study reports (CSRs), clinical study protocols (CSPs), statistical analysis plans (SAPs), and plain language summaries of results (PLSPs) to the Clinical Trials Information System (CTIS). This means sponsors need to prepare for the release of redacted clinical documents in a way that meets both transparency and confidentiality requirements.
Impact of the new transparency requirements
These changes place new emphasis on how documents are prepared, reviewed, and published. The scope of transparency now extends beyond CSRs to include more accessible summaries and supporting documentation. The redaction process is also under closer scrutiny, requiring careful justification of withheld information and ensuring that the publicly released version remains understandable and meaningful.
For medical writers, the latest transparency requirements are not just about compliance, they fundamentally influence how we write. One major shift is the growing need to tailor content for lay audiences. PLSPs must explain complex trial outcomes in language that a non-specialist reader can follow, without losing accuracy or scientific integrity. This requires skill in balancing clarity with precision, using plain language principles and patient-focused communication strategies.
In addition, many regulatory documents must now be prepared in both a “confidential” version for internal and regulatory use and a “public” version for disclosure. Medical writers must understand the redaction process well enough to anticipate what information may be removed, ensuring that the public-facing version still reads coherently. This often means rephrasing or restructuring sections to avoid leaving gaps that confuse readers.
The complexity of these transparency deliverables means that early planning is critical. From the outset of a project, medical writers should work closely with sponsors, regulatory affairs teams, legal reviewers, and data privacy specialists. Early alignment ensures that document structures, timelines, and content strategies account for both scientific accuracy and disclosure obligations.
Common pitfalls include leaving redaction considerations until the end, underestimating the time required for multiple review cycles, or overlooking inconsistencies between public and confidential versions. To avoid these, successful teams build redaction planning into their core writing process, use clear templates for transparency documents, and establish robust version control to track changes across multiple outputs.
Looking to the future
Transparency guidelines are likely to evolve further. The EMA has signalled interest in streamlining disclosure processes, expanding the scope of documents covered, and increasing automation in redaction and anonymisation.
For sponsors, staying ahead of these developments is not just about meeting legal requirements, it’s an opportunity to demonstrate integrity, foster public trust, and strengthen their reputation in the research community. For medical writers and transparency specialists, the ability to anticipate and respond to these changes is a key differentiator in the market.
The EMA’s latest transparency requirements mark another significant step towards open, patient-centred clinical research. However, with these changes come new operational challenges – from adjusting writing styles to coordinating across complex review teams.
Expert guidance
Our team specialises in guiding sponsors through the evolving transparency landscape. We combine regulatory expertise with practical experience in crafting both technical and lay-friendly content that meets EMA standards. Whether you need strategic advice or medical writing support, we can help you navigate these requirements efficiently and confidently.
If you’re ready to ensure your transparency deliverables are clear, compliant, and publication-ready, contact Boyds today to discuss how we can support your next project.