FAQs on Developing EMA Policy 0070 Submissions

The complete list of all disclosed documents to be included in a submission can be found in Annex I in the EMA Policy 0070 Guidance on pages 44-56. Before the Committee for Medicinal Products for Human Use (CHMP) Opinion, the EMA will provide a list of required documents (List of Expected Document/LED) to each applicant with a Marketing Authorization Application.

The List of Expected Documents (LED) should be shared before the CHMP opinion along with the invitation letter to submit a Redaction Proposal Document Package. This should arrive <90 days before the planned CHMP opinion date.

Both strategies are allowed. Each strategy has pros and cons (read about the differences between redaction and transformation anonymization methods). Time, cost, resources, and experience will contribute to your decision on choosing redaction or transformation.  

At Certara, we have expertise in both areas. We can advise on the benefits and limitations of qualitative and quantitative processes and propose the best way forward.

Certara uses leverages TrialAssure software to redefine clinical trial transparency and disclosure practices.  

TrialAssure provides comprehensive risk assessment and protects clinical trial data accordingly. The benefit of using software tools is automation, which allows for fast and consistent data processing.  

The process of data protection requires some human intervention due to language semantics, data formatting variations, specific client requests, or unique dataset characteristics (rare diseases, small populations, etc.). Our Transparency & Disclosure team are experts at using TrialAssure to efficiently and effectively protect personal and commercial data.

There are pros and cons for both processes. In short, the qualitative process redacts any data that could identify patients or study personnel, regardless of risk. The quantitative approach uses a more sophisticated empirical risk calculation strategy.  

Time, cost, resources, quantity of data released, and final data utility all vary between these two processes. The EMA accepts both strategies, as they both result in documents that protect personal and commercial data.

Policy 0070 is for drug products that have requested marketing authorization only. EU CTR submissions must still be made for all trial-related information generated during the life cycle of the clinical trial, including before the marketing authorization application.

Not automatically. These should be separate uploads made independently to Policy 0070 and to EU CTR, but both should abide by the same data protection & Commercially Confidential Information (CCI) rules (read more about how to identify CCI in this blog). 

• Policy 0070 provides proactive publication of eCTD Module 2.5. 2.7 and 5.3 for products that have requested marketing authorization.
• Policy 0043 provides any document for a medicinal product that has applied for marketing authorization upon request only.
• EU CTR proactively publishes all clinical trial-related information generated during the life cycle of a clinical trial for investigational products whether they have marketing authorization or not.

The Redactional Proposal Package documents can be submitted as early as day 181 after the submission of the application for marketing authorization. This should align with 30 days before the CHMP opinion.  

Upon request, the EMA will proactively review CCI and the anonymization strategy before submission. Thus, regulators can make comments on CCI before the submission of the Redaction Proposal Package. This could significantly speed up the review process. Refer to specific procedural timelines here.  

The entire review (including any revisions) shouldn’t take longer than 84 days following submitting the Redaction Proposal Document package. Specifics on the review and consultation process and timelines are in section 3.3.2. in the Policy 0070 Guidance. 

If regulators request a revision of the redacted content, the applicant has 7 days to provide a written agreement on the revision. Applicants have another 7 days to revise the Anonymization Report, the CCI Redaction Control Sheets, or document changes. Sponsors have requested extensions which regulators have granted. The EMA has expressed that they will attempt to accommodate applicants’ reasonable requests for extensions.

The review process is only for data protection. The content of the actual studies would have been reviewed before the CHMP opinion, at which point regulators would have requested additional information. The feedback following the submission of the Redaction Proposal Document package only concerns clarification on CCI and the data anonymization process (typically within the Anonymization Report).

All EMA Policy 0070 publications reside on their Data Sharing portal. To use this site, you must create a free EMA account. This account gives access to all publications that are searchable by key terms, product name, marketing authorization holder, active substance, and many other options.

On May 14, 2025, the EMA released Version 1.5 of its external guidance on implementing Policy 0070. This update introduced “blinding (BLD) redactions,” for the temporary redaction of interim results from blinded studies that are still ongoing when the initial data is published. This prevents the premature unblinding of studies, which could compromise their integrity. The guidance also allows for the deferral of entire documents if the number of BLD redactions would significantly reduce data utility.

The process requires prior agreement with the EMA and involves two stages: an interim submission and a final submission. 

1. Interim Submission: In this stage, you apply BLD redactions to documents containing interim results from ongoing blinded studies. You must also update the Anonymization Report Form to explain which data is blinded and which documents, if any, are being deferred.
2. Final Submission: Once the studies are unblinded, you proceed with the final submission. Here, you remove all BLD redactions and include any documents that were previously deferred. The Anonymization Report Form is updated to reflect these changes. 

Early and strategic planning is critical. We recommend forming a cross-functional team as soon as possible to identify which information could lead to premature unblinding and to define your BLD strategy. 

Engage with the EMA during the pre-submission meeting to discuss the need for BLD redactions and get their agreement on your proposed approach. The EMA may request sample documents with BLD redactions at this stage. Even if some documents will be deferred, it’s wise to submit all documents—anonymized for PPD and CCI—for EMA review during the Redaction Proposal Document Package stage. This allows the EMA to review everything at once, streamlining the process for incorporating any required changes.

Do you need help planning for your EMA Policy 0070 submission? Our Transparency & Disclosure experts can help.