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any applications for line extensions or new indications, or where the MAA results in a negative opinion or is otherwise withdrawn.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receive a positive or negative opinion from the Committee for Medicinal Products for Human Use (CHMP), or which are withdrawn.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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Photo of Grant Castle Grant Castle

Grant Castle is a partner in London, Brussels, and Dublin practicing in the areas of EU, UK, and Irish life sciences regulatory law. He supports innovative pharmaceutical, biotech, medical device and diagnostics manufacturers on regulatory, compliance, legislative, policy, market access and public law…

Grant Castle is a partner in London, Brussels, and Dublin practicing in the areas of EU, UK, and Irish life sciences regulatory law. He supports innovative pharmaceutical, biotech, medical device and diagnostics manufacturers on regulatory, compliance, legislative, policy, market access and public law litigation matters in the EU, UK, and Irish Courts.

He is one of the Co-chairs of Covington’s Life Sciences Industry Group and is Head of Covington’s European Life Sciences Regulatory Practice.

Grant regularly advises on:

  • EU and UK regulatory pathways to market for pharmaceuticals and medical devices, including in vitro diagnostics and on associated product life cycle management;
  • Pharmaceutical GxPs, including those governing pharmacovigilance, manufacturing, the supply chain and both clinical and non-clinical research;
  • Medical device CE and UKCA marking, quality systems, device vigilance and rules governing clinical investigations and performance evaluations of medical devices and in vitro diagnostics;
  • Advertising and promotion of both pharmaceuticals and medical devices; and
  • Pricing, reimbursement and market access for both pharmaceuticals and medical devices.

Grant also handles procedural matters before EU, UK and Irish regulators and UK and Irish market access bodies, where necessary bringing judicial reviews for his life sciences clients before the EU, UK and Irish Courts.

Chambers UK has ranked Grant in Band 1 for Life Sciences Regulatory for the last 21 years. He is recognized by Chambers UK, Life Sciences as “excellent,” “a knowledgeable lawyer with a strong presence in the industry,” who provides “absolutely first-rate regulatory advice,” according to sources, who also describe him as “one of the key players in that area,” whilst Chambers Global sources report that “he worked in the sector for many years, and has a thorough understanding of how the industry ticks.” He is praised by clients for his “absolutely first-rate” European regulatory practice. Legal 500 UK notes that he is “highly competent in understanding legal and technical biological issues.”

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Photo of Robin Blaney Robin Blaney

Robin Blaney is a partner in the firm’s Life Sciences practice.  He advises pharmaceutical, biotechnology, medical device and cosmetic manufacturers and trade associations on a wide range of regulatory, compliance, transactional and legislative matters, as well as the full range of commercial agreements…

Robin Blaney is a partner in the firm’s Life Sciences practice.  He advises pharmaceutical, biotechnology, medical device and cosmetic manufacturers and trade associations on a wide range of regulatory, compliance, transactional and legislative matters, as well as the full range of commercial agreements that span the product life-cycle in the life sciences sector.  His expertise includes clinical trial agreements, manufacturing and supply agreements, distribution and other marketing agreements, regulatory services agreements, and tenders.  He has particular experience structuring and documenting EU pharmaceutical distribution arrangements and transitional arrangements relating to product acquisitions.  Robin writes and speaks regularly on subjects such as medical device regulation, pharmacovigilance and clinical trials.

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Photo of Roderick Dirkzwager Roderick Dirkzwager

Roderick Dirkzwager advises clients in the life sciences sector on a broad range of regulatory, transactional and intellectual property matters relating to the discovery, development and commercialization of their products.

Roderick is a member of Covington’s Diversity and Inclusion Committee and is a…

Roderick Dirkzwager advises clients in the life sciences sector on a broad range of regulatory, transactional and intellectual property matters relating to the discovery, development and commercialization of their products.

Roderick is a member of Covington’s Diversity and Inclusion Committee and is a co-lead of the LGBT+ Affinity Group in London.

With a broad life sciences practice, Roderick regularly advises on:

  • EU, Irish, and UK regulatory issues relating to pharmaceutical products and medical devices;
  • commercial agreements that span the product life-cycle in the life sciences sector, including collaborations and other strategic agreements, clinical trial agreements, distribution arrangements and manufacturing and supply contracts;
  • regulatory and commercial due diligence for life sciences transactions; and
  • intellectual property issues arising in corporate transactions and IP-related contracts.

Roderick is also a member of Covington’s Life Sciences in Africa team and advises clients on regulatory and commercial strategies for the supply of medical products across Africa, including through international recognition procedures such as WHO pre-qualification. Prior to joining the firm, Roderick completed his Ph.D. in Biochemistry, focusing on the development of novel, low-cost malaria diagnostic technologies using DNA aptamers.

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