In recent years, the pharmaceutical industry has been under increasing pressure to improve transparency, particularly when it comes to sharing clinical trial data. As the demand for open access to clinical research grows, regulatory bodies are stepping up to ensure that public health decisions are made based on comprehensive, accessible information.
The European Medicines Agency (EMA) has been actively working in this movement, and the reinstatement of Policy 0070 in September 2023 marks a pivotal moment for both pharmaceutical companies and the global clinical trials landscape. This policy aims to make clinical trial data more accessible and has undergone significant changes to streamline processes and improve transparency in clinical research.
Phased Restart of EMA Policy 0070
EMA Policy 0070 was introduced in 2015 to enhance transparency in clinical research by making clinical trial data publicly available. The policy grants public access to clinical reports submitted by pharmaceutical companies during the marketing authorization process. After an extended hiatus, the policy restarted from September 1st, 2023.
This revival came in response to critics who speculated that the policy might be permanently scrapped. EMA’s decision to restart Policy 0070 highlighted its continued commitment to data transparency and to improving the accountability of clinical trials. The policy’s main objective remained to provide wider access to clinical data, to empower healthcare professionals, researchers, and the public to make better-informed decisions about new treatments and therapies.
What do you need to know?
The reinstated policy primarily focuses on marketing authorization applications (MAAs) for new active substances (NAS), including initial submissions, line extensions, and applications for products with withdrawn indications. From EMA’s Committee for Medicinal Products for Human Use (CHMP) started issuing opinions on these applications, whether the decision is favorable or not. This inclusive approach has helped ensure that clinical trial data related to both approved and rejected applications is accessible.
Timelines: Sponsors began receiving invitation emails from EMA in June 2023 to begin the process for valid applications. They were provided with the updated Q&A, submission checklist, and a draft list of documents eligible for publication.
Redaction Proposals: Sponsors should submit a Redaction Proposal Document package following the CHMP opinion:
- For Initial MAAs and line extensions- The redaction package must be submitted between Day 181 and 30 days after the CHMP opinion.
- For Article 58 applications- The package must be submitted within 60 days post-CHMP opinion.
- For extension of indication applications- The redaction proposal should be submitted between 30 days before to 30 days after the CHMP opinion, which previously had been a stricter deadline.
- For withdrawn applications- The proposal must be submitted within 60 days of receiving the withdrawal letter from EMA.
These changes signal a more flexible and accessible approach, allowing sponsors to better manage their submission timelines while ensuring compliance with EMA’s transparency objectives.
Structured Anonymization Report (AnR) Template
As part of the revival, EMA introduced an updated Anonymization Report (AnR) template, allowing sponsors to structure the anonymization of clinical trial data in a more straightforward and standardized way. Featuring tick boxes, data tables, drop-down lists, and limited free text, the new AnR template is designed to streamline the data redaction process, making it easier for pharmaceutical companies to submit their materials in a compliant manner. The AnR template became available by September 2023, aligning with the EMA Policy 0070 and Health Canada’s joint guidelines.
The simplification of the redaction process was aimed at improving the speed and accuracy with which data can be anonymized before publication, ensuring that sensitive data is properly protected while maintaining the overall transparency of the trial results.
Managing Confidential Information (CCI)
One of the many challenges pharmaceutical companies face when submitting clinical trial data is the management of confidential company information (CCI). EMA noted that the CCI acceptance ratio during the pandemic was exceptionally low, highlighting the importance of a thorough public domain search to justify the inclusion of CCI. For a proposal to be accepted, EMA requires detailed justifications and a clear CCI strategy within the submission package. This process ensures that only proprietary information, such as trade secrets or other sensitive data, is protected from public release, while still enabling full access to the trial results.
Pharmaceutical companies must ensure that their CCI proposals are comprehensive and well-documented to avoid rejection during the submission process. They need to find a balance between transparency and protecting their intellectual property.
EMA Policy 0070 and the EU Clinical Trial Regulation (EU-CTR)
EMA Policy 0070 is closely aligned with the EU Clinical Trial Regulation (EU-CTR), which came into force in 2022. Both frameworks are designed to enhance the transparency and accessibility of clinical trial data within the European Economic Area (EEA). As the CTIS (Clinical Trial Information System) and EMA Policy 0070 teams collaborate on a common guidance document, the two policies will work in tandem to improve the accessibility of trial data and support better decision-making in the medical field.
This collaboration between EMA Policy 0070 and EU-CTR signals a new era for clinical trials in Europe, where the dual focus on transparency and streamlined procedures will create a more efficient, trustworthy, and collaborative environment for clinical research.
Global Implications for Clinical Trials and Regulatory Practices
The revival of EMA Policy 0070 carries significant implications for the global clinical trials outlook. Pharmaceutical companies worldwide must now adopt more rigorous data-sharing practices, ensuring that trial data is ready for publication in compliance with EMA’s updated requirements. This policy’s reach goes beyond Europe, influencing clinical trial transparency in countries like Canada, Australia, and even the United States, where similar initiatives are in place.
The updated timelines and revised procedures provide pharmaceutical companies with more flexibility, but they also demand higher levels of preparedness. Companies will need to work closely with regulatory bodies to ensure that their data is compliant, transparent, and well-prepared for publication.
Conclusion
EMA Policy 0070’s phased restart is a strategic move toward a more open, accountable, and ethically responsible pharmaceutical industry. By committing to transparency, EMA is helping to ensure that clinical trial data is accessible to those who need it most—healthcare professionals, researchers, and patients, while also protecting sensitive information.
As global regulatory frameworks continue to evolve, the impact of EMA Policy 0070 is likely push manufacturers to adopt more transparent, compliant, and ethically sound practices in clinical trials. Pharmaceutical companies must now prepare to align with these updated requirements to maintain their market presence and uphold the highest standards of clinical research.
DDReg offers specialized clinical regulatory services to assist with Clinical Trial Applications. For further information, contact our experts. Read more from the experts about Clinical Trials here: Navigating the New Requirements for Diversity in Clinical Trials