The European Medicines Agency (EMA) is advancing its commitment to clinical trial transparency with the recent launch of Policy 0070 Step 2 in May 2025. This phase builds upon the policy’s core mission to proactively publish clinical data for medicinal products while safeguarding patient privacy and commercially confidential information (CCI). Step 2 introduces expansions in scope, refined processes, and enhanced collaboration, marking a pivotal moment for sponsors, regulators, and stakeholders.
Expanded Scope: Broadening the Horizon of Transparency
Step 2 significantly broadens the range of applications subject to clinical data publication, ensuring a wider array of clinical insights reaches the public domain. The key updates include:
- New Marketing Authorization Applications (MAAs): All new MAAs, regardless of whether they receive a positive or negative opinion from the Committee for Medicinal Products for Human Use (CHMP), will have their clinical data published.
- Withdrawn Applications: Clinical data from MAAs withdrawn before a CHMP opinion will now be disclosed, shedding light on early-stage development decisions.
- Line Extensions: Data from applications for new formulations, routes of administration, or presentations of existing medicines are now in scope.
- Major Clinical Type II Variations: Extensions of indications, representing new therapeutic uses for approved medicines, will also be published.
- Special Cases Continue: Data publication for COVID-19 treatments and medicines addressing public health emergencies will persist, as established in Step 1.
- Exclusions: Biosimilars, generics, and hybrid applications are exempt due to their limited clinical data.
This expanded scope reflects EMA’s push to make clinical data more accessible, fostering trust and enabling researchers, healthcare professionals, and the public to better understand the development of medical products.
Updated Guidance and Documentation: Supporting Sponsors
To assist sponsors in navigating these changes, EMA is rolling out updated resources:
- Revised External Guidance: The External Guidance on Policy 0070 is being updated to address anonymization of personal and company information.
- Updated Q&A Document: A revised Questions and Answers document will be released in 2025 to clarify Step 2 requirements.
These resources aim to provide clarity and support to sponsors, ensuring they can effectively comply with the new requirements and contribute to the overarching goal of clinical trial transparency.
Collaboration and Harmonization: A Unified Approach
Step 2 emphasizes collaboration to reduce administrative burdens and align with global standards:
- Internal Alignment: EMA has developed an internal tracking system to manage applications more efficiently, paired with an in-house document identification system. This system generates a list of documents in scope, which is included with the invitation letter sent to sponsors.
- Stakeholder Engagement: EMA is increasing engagement with sponsors through written communication and dedicated meetings to refine anonymization strategies, particularly for narrative data.
- External Collaboration with Health Canada: EMA and Health Canada now mutually accept anonymized packages for MAAs with at least 70% document overlap, easing the burden on sponsors submitting in both regions.
This collaborative approach not only streamlines processes for sponsors but also reinforces the global commitment to clinical trial transparency.
Handling Legacy Procedures: Clarifying the Past
Products authorized during the Policy 0070 suspension are not subject to immediate publication, and EMA has no plans to request their data unless specifically requested. This decision provides clarity for sponsors regarding historical submissions and focuses resources on current and future applications.
EMA/Health Canada Pilot Workshare: A Model for International Cooperation
The European Medicines Agency (EMA) and Health Canada are deepening their collaboration to streamline the submission process. Under this enhanced partnership, both regulators will accept clinical data packages previously approved by the other without modifications, provided the documents remain unchanged. This mutual acceptance applies to submissions that meet the following guidelines:
- The Marketing Authorization Application (MAA) is submitted to both the EU and Canada.
- There is at least 70% overlap between the document packages submitted to EMA and Health Canada.
- The regulatory opinion window for the packages does not exceed six months.
For packages meeting these criteria, a single designated regulator will conduct the review, following that regulator’s specific guidance. Non-overlapping documents will be reviewed separately by the respective regulator before publication. After a joint assessment, the regulators will issue a single outcome. This coordinated approach aims to reduce the administrative effort required to prepare, review, and submit separate packages to both regulators simultaneously.
Looking Ahead: Embracing Transparency
EMA Policy 0070 Step 2 represents a significant step toward greater transparency in clinical data while balancing privacy and confidentiality. Sponsors are encouraged to engage early, leverage pre-submission meetings, and consult updated guidance to navigate the expanded scope and requirements effectively. As EMA continues to refine its processes and collaborate globally, the pharmaceutical industry can expect a more transparent, harmonized, and efficient framework for clinical data publication.
For more detailed information on EMA Policy 0070 and its implications, please refer to the EMA’s official documentation:
- EMA Clinical Data Publication¹
- EMA Policy 0070 Draft²
- Health Canada’s Public Release of Clinical Information³
By staying informed and proactive, stakeholders can contribute to a more transparent and trustworthy clinical research environment.
1 – European Medicines Agency. Clinical Data Publication. EMA, 2024, www.ema.europa.eu/en/human-regulatory/marketing-authorisation/clinical-data-publication. Accessed 15 May 2025.
2 – European Medicines Agency. Draft Policy 0070 on Publication and Access to Clinical-Trial Data. EMA, 2014, www.ema.europa.eu/en/documents/other/draft-policy-70-publication-and-access-clinical-trial-data_en.pdf. Accessed 15 May 2025.
3 – Health Canada. Public Release of Clinical Information Guidance Document. Government of Canada, 2021, www.canada.ca/en/health-canada/services/drug-health-product-review-approval/profile-public-release-clinical-information-guidance/document.html. Accessed 15 May 2025.
