Pharma IT Insights
The more we know, the better: The Benefits of EMA Policy 70
By Anne Louise Kirkegaard
November 13, 2025
This content is published by Halloran Consulting and Pharma IT.
Pharma IT Insights
The more we know, the better: The Benefits of EMA Policy 70
By Anne Louise Kirkegaard
November 13, 2025
This content is published by Halloran Consulting and Pharma IT.
“What is the European Medicines Agency (EMA) Policy 70?” and “Can you help our organization align to EMA Policy 70?” are two common questions my team and I are asked by the industry. Can you relate?
Since we are better together, I believe efficiency and innovation happen when we come together to share recommendations and best practices, especially when we are called to do things differently.
Let’s begin with the basics of the policy.
Understanding EMA Policy 70
The EMA Policy 70 is designed to increase transparency in the development and evaluation of medicines by requiring and expanding the publication of clinical data submitted for regulatory approval within the European Union (EU). The intent behind the policy is to increase trust and transparency by making clinical data accessible for scrutiny and for reuse in future research to support public health knowledge.
Since 2014, the scope of EMA Policy 70 has significantly expanded to include a broader range of clinical data submissions and applications for medicines beyond just its initial focus. As of April 2025, the policy now covers not only initial marketing authorization applications (MAAs) for new active substances, but also for:
Line extension applications, including changes to active substance, strength, pharmaceutical form, or route of administration Major clinical Type II variations, such as applications to add new indications or therapeutic uses
Applications resulting in negative opinions or have been withdrawn before decisions are now included, with clinical data still published regardless of the outcome
Generally, all clinical reports submitted as part of a regulatory application will be subject to publication, including clinical overview, clinical summary, clinical study reports, and clinical study reports appendices.
What does this all mean? This new direction is essential because it enables more scientific data to become available, which informs the public. When patients and scientists are better informed, they are more appropriately guided to build research, paving a new path forward for their own health or their development program in focus.
Challenges with Applying the Revised Framework
The policy, as well as the external guidance document (linked above), makes the Redaction Proposal Document Package (RPDP) process clear; for example: what should be redacted, how to redact, and what data should be anonymized to preserve patient privacy. These parameters are key, but the work is striking the right balance of information, requiring a strategic approach to avoid over-redacting or under-redacting.
Achieving this balance demands significant, often time-consuming administrative work, requiring cross-functional team input. Those that are involved are likely in regulatory affairs, medical writing, IT, clinical, and legal.
In addition to the time-consuming factor, knowing where to begin is a common challenge. As companies engage in the process, they’re often new at this, lacking the right amount of strategic knowledge to identify and justify redactions, or justify preserving certain data.
It must be emphasized that starting the strategic process early will always work in a company’s favor. For example, if a biotech writes their clinical trial protocol with EMA Policy 70 in mind, they will have a strategic process to follow from the onset to prevent a timely data cleanup project in preparation for go-to-market. As with all regulatory requirements, begin with the end goal in mind and consider Policy 70 early on to save significant time and effort.
Consequences of Under- or Over-Redacting Data
Going too far on one side risks timely market access. And in biotech, there’s always a race against the clock. Let’s explore more.
Risks of Over-Redacting
- Loss of transparency: Excessive redactions can obscure key scientific information, undermining the policy’s goal to foster transparency and build public trust.
- Regulatory pushback: EMA explicitly challenges over-redaction practices, especially when redactions are used to conceal non- sensitive data or limit public access unjustifiably, which can lead to additional requests for justification or resubmission delays.
- Negative perception: Stakeholders such as researchers, healthcare professionals, and patients may view over-redacted documents as suspicious or less credible, potentially damaging a company’s reputation.
- Increased workload: Repeated queries from EMA and rework to correct excessive redactions add to the compliance burden and may delay marketing authorization processes.
Risks of Under-Redacting
- Patient privacy breaches: Insufficient redaction of personally identifiable information can compromise patient confidentiality, potentially violating data protection laws like GDPR and exposing the company to legal risks.
- Disclosure of trade secrets: Failure to appropriately redact commercially confidential information can reveal proprietary data, impacting competitive advantage and future product development.
- Regulatory non-compliance: EMA may reject submissions with inadequate redactions, requiring costly and time-consuming corrections and resubmissions.
Legal and financial consequences: Breaches of confidentiality or privacy can result in penalties, litigation, or loss of intellectual property protections
Balancing redactions to protect sensitive information while maximizing transparency is vital, but not always simple and easy to accomplish. Companies need rigorous review, justified and well-documented redactions, and must follow EMA’s formatting and procedural requirements to avoid these risks.
For additional support, engage with a seasoned advisor who can provide you with a strategic redaction roadmap that is fit-for-purpose in preparation for the RPDP.
Turning Compliance with Policy 70 into a Strategic Advantage
Compliance is fundamental. If a company is not compliant, they cannot advance. Beyond following the policy, there is an upside to this framework. There is a significant advantage when the right data is available to the right people – patients, Key Opinion Leaders, and communities – because information has the potential to transform the market. Viewing this policy as an accelerator rather than a hurdle is a strategic advantage.
As with every change or demand, immediate adverse reactions lesson with time, and we see those requirements become more integrated and mainstream within the organization. But if tools or policies aren’t viewed as an enabler, or are ignored, there is a risk of being left behind by competitors. To fully embrace this policy, I believe, requires a shift in mindset.
As an industry, it’s critical that we come together when challenges and opportunities arise, and this is the direction we need. This is the direction we need to support data transparency that is essential for building public trust in biotech and pharmaceutical products.
💡 If you need assistance navigating EMA Policy 70 or developing a strategic redaction approach, our experienced consultants are ready to support you.
About the author
Anne Louise Kirkegaard is Director of Regulatory Affairs & Medical Writing Services and Principal Pharma Consultant at Pharma IT. She holds more than 20 years’ experience from the biotech and pharmaceutical industry working with Regulatory Affairs in development, registration and post-approval of drug products, drug-device combination products, food supplements and cosmetics.
