EMA Clinical Data Publication Policy to Cover All New Marketing Authorization Applications, Line Extensions and Major Clinical Type II Variations Starting Q2 2025

The European Medicines Agency (EMA) has announced that it will expand its activities under its clinical data publication policy (CDP Policy, also known as Policy 0070) to cover all clinical data submitted under new marketing authorization applications (MAAs) for medicinal products as well as any applications for line extensions or new indications, or where the MAA results in a negative opinion or is otherwise withdrawn. These expanded activities are due to apply for MAAs submitted from April 2025 onwards.

The EMA originally implemented its CDP Policy in October 2016. The policy provides a proactive obligation on the EMA to publish clinical data submitted to the agency under any MAA submitted via the EU centralized procedure. However, the EMA has faced challenges during implementation of the policy due to operational constraints. The CDP Policy therefore currently only applies to the following centralized procedures:

• applications for COVID-19 medicines; and
• initial MAAs for new active substances that receive a positive or negative opinion from the Committee for Medicinal Products for Human Use (CHMP), or which are withdrawn.

The latest announcement from the EMA means that line extensions and applications for major clinical Type II variations (such as the extension of indications) will similarly be subject to the CDP Policy from April 2025. However, biosimilar, hybrid and generic MAAs are still excluded from the scope of the CDP Policy. These types of applications usually include limited clinical data, and the EMA had observed that these data sets were infrequently accessed by the public when previously made available under the CDP Policy.

What clinical data is subject to the CDP Policy?

The CDP Policy applies to the following categories of data submitted with a centralized procedure MAA:

• the clinical overview, which provides a critical analysis of the clinical data in the submission package, including the conclusions and implications of the clinical data;
• the clinical summary, which provides a detailed factual summarization of all the clinical information submitted;
• the study reports for the individual clinical studies; and
• three appendices to the clinical study reports, namely the study protocol, the sample case report form used to record information on an individual patient, and documentation of the statistical methods used to analyze the data.

These data correspond respectively to modules 2.5, 2.7 and 5.3 of the Common Technical Document (CTD) dossier. The CDP Policy does not apply to:

• MAAs submitted before January 1, 2015;
• clinical data that is not held by the EMA (e.g., independent clinical trials on the product whose data is not included in the MAA);
• pharmacovigilance data based on individual case safety reports (which fall under the EMA's EudraVigilance access policy);
• components of the MAA that do not fall under the definition of 'clinical data;'
• any patient or healthcare professional personal information; and
• commercially confidential information (CCI).

Applicants may submit redacted versions of such information and documents for publication to remove any personal information and CCI. However, applicants must appropriately justify any redactions of CCI.

Changes Announced by the EMA

The EMA's latest webinar on November 14, 2024 confirmed its intention to expand the application of its CDP Policy from April 2025 to include line extension applications (which may include applications concerning changes to the product's active substance, strength, pharmaceutical form and/or route of administration) and applications for major clinical Type II variations, such as adding new indications.

The EMA's announcement also sets out new extended publication timelines under the CDP Policy. Under current policy, redacted/anonymized clinical reports will be published within 60 days after the Commission's marketing authorization decision. Under the latest proposal, publication will occur within 120 days after the CHMP opinion. Applicants will now also have up to 30 days from the CHMP opinion to prepare and submit their redaction proposals (which is an increase of 20 days from the current position). Publication of redacted/anonymized clinical reports for withdrawn applications will still occur 150 days after the withdrawal request, although applicants will have up to 60 days from the date of withdrawal to prepare and submit their redaction proposal. The EMA expects to issue additional guidance on these processes in early 2025.

Finally, the EMA also announced details of a new proposed collaboration with Health Canada, which aims to align the processes, timings and scope of clinical data being published by each agency and assess the potential for a single review procedure for certain applications.

What About Legacy Clinical Data?

The EMA previously indicated that it would apply the publication requirements under its CDP Policy to all clinical data submitted under legacy MAAs since January 1, 2015. However, given the significant volume of clinical data that this process would entail, the EMA has changed course and will instead operate a "publication upon request" policy for such legacy clinical data. The EMA will provide reactive publication of such clinical data in response to any access to document requests it receives from the public. Such access to document requests will need to be submitted and assessed in accordance with the Transparency Regulation (EC) No 1049/2001 and the EMA's transparency guidance.

CTIS Transparency Requirements

The CDP Policy only applies to clinical data submitted to support MAAs. However, the EMA also has separate publication procedures in place for EU clinical trial data submitted to the Clinical Trials Information System (CTIS) database as required under the EU Clinical Trials Regulation (EU) No. 536/2014. Although there is significant overlap between the scope of clinical data and trial information disclosure under the CDP Policy and through the CTIS, both regimes will continue to apply in parallel under each policy's relevant timelines.

The EMA plans to publish additional guidance and details regarding these changes in early 2025. If you have any queries concerning the material discussed in this blog or EU medicines regulations more broadly, please contact us for more information.

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