EMA Policy 0070 Guidance: Transparency in Clinical Data Publication – Version 1.5 (May 2025)

The European Medicines Agency (EMA) has long committed to this principle through Policy 0070, which governs the publication of clinical data submitted for centralised marketing authorisation procedures. On 14 May 2025, EMA released Version 1.5 of the "External guidance on the implementation of the European Medicines Agency Policy 0070 on the publication of clinical data for medicinal products for human use", offering a refined and comprehensive overview of how clinical data must be prepared, redacted, anonymised, and submitted for publication.

Policy 0070 refers to the EMA's framework for the proactive publication of clinical data for human-use medicines, in line with Article 80 of Regulation (EC) No. 726/2004. It aims to increase transparency, foster public trust, and allow stakeholders (researchers, professionals, and the public) to better understand medicine safety and efficacy.

The scope of EMA Policy 0070 includes centrally authorised marketing authorisation applications (MAAs), including initial MAAs, line extensions, new indications, and applications for products authorised during a public health emergency. It also applies to withdrawn applications, but only when the applicant withdraws after receiving a request from the EMA for the submission of a redaction proposal package.

Submission Process and Timelines

The process begins when the EMA sends a formal invitation to submit the Redaction Proposal Document Package (RPDP). From the date of the invitation, applicants are required to submit their RPDP within 60 calendar days. This submission must include:

• A cover letter

• A justification table for proposed CCI redactions

• An anonymisation report, which details the methodology used to ensure personal data cannot be re-identified

• Draft redacted versions of all clinical reports in line with EMA's format and file naming conventions

The RPDP is reviewed by the EMA for both technical and content validation. Following validation, a scientific review of the proposed redactions is conducted, and feedback is provided via a Redaction Conclusion Letter. Applicants then have 60 days to submit the Final Redacted Document Package (FRDP), which is subject to final validation before publication.

Anonymisation and Protection of Personal Data

The guidance emphasises that anonymisation must be robust and reproducible. Applicants are required to submit an anonymisation report outlining the techniques used (e.g., generalisation, suppression) and assessing the residual risk of re-identification. Redactions must strike a balance between protecting privacy and maintaining the scientific utility of the data.

Importantly, case narratives are expected to be anonymised, not redacted. Full redaction of narratives is only accepted in rare circumstances and must be thoroughly justified.

Commercially Confidential Information (CCI)

All CCI redactions must be supported by a justification table, which lists each redaction alongside the rationale and the potential harm if the information were disclosed. EMA makes it clear that over-redaction or use of CCI claims to avoid publication of non-sensitive data will be challenged. CCI must only cover content that is proprietary and non-public, such as novel manufacturing methods, pending patent information, or unique study design elements not publicly known.

Document Preparation and Formatting

All clinical documents must be submitted as searchable PDF files, with the unredacted text remaining selectable, while redactions (for CCI and personal data) must be non-selectable graphical redactions. The use of password-protected files, embedded fonts, and scanned images is strictly prohibited.

Redactions for personal protected data (PPD) must be marked in blue, and redactions for CCI must be marked in red. The naming of files and document structure must adhere strictly to EMA’s technical instructions to ensure automation compatibility.

If the marketing authorisation is transferred between companies during the publication process, the responsibility for fulfilling the obligations of Policy 0070 also transfers to the new MAH. Once the Final Redacted Document Package is approved and validated, the EMA aims to publish the data on its website within 10 working days.

The EMA’s Policy 0070, as reflected in the updated Version 1.5 guidance, reinforces the agency’s ongoing commitment to data transparency, public health, and scientific openness. By adhering to the requirements outlined in this version, MAHs can ensure the timely and successful publication of clinical data in a way that serves the broader interests of science and society.

Reference Link: EMA Policy 0070 External Guidance PDF