What To Know Before Embarking On Your EMA Policy 0070 Submission Project

Making the Most of the European Medicines Agency (EMA) Policy 0070 Pre-Submission Meeting

Policy 0070 Background

EMA Policy 0070  (otherwise known as Clinical Data Publication, or CDP), is a policy implemented by the European Medicines Agency (EMA) that governs the publication of clinical data for medicinal products for human use. The policy aims to increase transparency and public access to clinical data while protecting patient confidentiality and commercially sensitive information. 

History of CDP/Policy 0070

  • 2014     Policy adopted
  • 2015     Phase 1 implementation
  • 2018     Policy on-hold due to Brexit and COVID (except COVID treatments)
  • 2023     Relaunch initiates in September
  • 2024     Anticipated relaunch scope expansion 
  • Future  Phase 2 implementation (date TBD)

Key Policy 0070 Terms

Committee for Medicinal Products for Human Use (CHMP): The scientific committee of the EMA that provides opinions on marketing authorization applications.

Marketing authorization application (MAA): The formal application submitted by a pharmaceutical company to obtain marketing authorization for a medicinal product.

Marketing authorization holder (MAH): The individual or company responsible for the marketing of a medicinal product.

Pre-submission Meeting (PSM): The meeting held between Sponsor and EMA to review the scope, strategy and timescales for the Policy 0070 submission.

See our Policy 0070 FAQ page for more background info and key terms.

What is the EMA Policy 0070 Pre-Submission meeting?

The EMA Policy 0070 pre-submission meeting is a critical  opportunity for sponsors to discuss their plans for complying with the policy with the European Medicines Agency (EMA) before formally submitting their Proposal Package (PP). 

The pre-submission meeting will confirm in-scope and out-of-scope content, anonymization strategy, use of vendor, CCI (if applicable) and submission schedule. This meeting can help to avoid delays and ensure a smooth submission process. It is especially helpful and valuable for sponsors submitting a Policy 0070 package for the first time.

Where in the MAA process does the Pre-Submission meeting occur?

The pre-submission meeting occurs prior to submitting the Proposal Package (PP). The value of the meeting comes from aligning early with the Health Authority on the personal data anonymization strategy and approach to protection of confidential information.

Ideally, your pre-submission meeting should occur no later than when you receive the invitation letter from EMA. You can (and should) begin your Policy 0070 project work prior to the invitation letter.  Please refer to the timeline illustration below for more details.

Reviewing and confirming your anonymization strategy with EMA early in the process allows you to incorporate their feedback into your Proposal Package, thereby streamlining the validation process and potentially preventing future delays or rework.

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Figure 1F

The Pre-Submission Meeting

 Here's what you need to know:

Purpose of the Pre-Submission meeting

  • Facilitate open discussion with the EMA on your intended clinical data publication (CDP) submission.
  • Identify potential issues or concerns early on to avoid delays or rejection.
  • Get feedback on your proposal document package, including your anonymization approach and strategy.
  • Discuss scope details and timelines.
  • Establish an early dialogue and relationship with the EMA.

Who should attend?

  • Representatives from your company familiar with the submission and anonymization  process, including regulatory affairs, scientific experts, and data anonymization specialists.
  • Real Life Sciences, who will support you in the preparation of content for the meeting, including the recommended anonymization strategy for your project.
  • Representatives from the EMA's Clinical Data Publication Team (CDP Team).

What to prepare

  • A list of specific questions you have for the EMA.
  • A few slides summarizing your progress on the CDP process.
  • Your Anonymization strategy.
  • Your listing of Commercially Confidential Information.

Key Topics for Discussion

  • Submission scope and schedule.
  • Your recommended anonymization technique/strategy.
  • Scope and justification for Commercially Confidential Information.
  • Timeline and milestones for publication.

Benefits of a Pre-Submission Meeting

  • Increased clarity and confidence in your CDP submission.
  • Reduced risk of delays or rejection due to non-compliance or technical issues.
  • Improved communication and collaboration with the EMA.
  • Streamlined publication process leading to faster access to clinical data.

Additional Preparation Items Before Embarking on Your Policy 0070 Project

  1. Assemble your team including Clinical Transparency, BioStats, Regulatory
  2. Engage with Real Life Sciences for expert advice, preparation for and facilitation of the pre-submission Meeting and delivery of the complete proposal and final packages
  3. Gather the in-scope Policy 0070 CTD document set - specifically ICH CTD/eCTD M2.5, M2.7 and M5
  4. Gather the applicable trial datasets which can be used in support of an empirical analysis of subject data and later applied to the in-scope documents by RLS
  5. Review the EMA guidance for Policy 0070 
  6. Plan an internal kickoff for your project with help from RLS 

Policy 0070 Moving Forward

During the Policy 0070 relaunch in 2023 EMA and Health Canada demonstrated increased partnership which is expected to continue moving forward. This is evidenced, for example, through the jointly revised Anonymization Report Templated to be used by Sponsors when submitting their Policy 0070 (and Health Canada PRCI) Proposal Packages. This collaboration between the two Health Authorities benefits Sponsors given the similarities in the two policies. 

The revised Anonymization Report Template requires trial sponsors to indicate which type of anonymization methodology they have adopted for the submission, among other important points pertinent to the project. If trial sponsors do not indicate a quantitative  risk-based methodology they must include justification as to why. A quantitative anonymization methodology, otherwise referred to as “risk-based anonymization” applies empirical measures to assess the risk of reidentification of the resulting anonymized data - based on analysis of the subject data itself. 

In contrast, a qualitative or “rules based anonymization” approach applies a static set of anonymization rules to the data, however, the results are not quantifiable and therefore the risk of r identification is not measured. As the Anonymization Report Template has evolved, including this most recent set of revisions as published Fall 2023, it is becoming increasingly clear the Health Authorities have a strong preference to a Quantitative risk-based anonymization methodology. While RLS supports both quantitative and qualitative approaches, our experience suggests most Sponsors prefer quantitative methods because it is measurable (the risk of reidentification is known) and it supports maximizing the clinical utility of the resulting data.  

Given EMA and Health Canada appear to prefer a risk-based anonymization method when evaluating Policy 0070 submissions, and because of the inherent benefits of a risk-based anonymization approach, RLS recommends sponsors adopt this methodology. That said, there may be certain specific situations where a rules based or qualitative methodology is best.  Most certainly this underscores the importance of the pre-submission meeting. As mentioned above, the trial sponsor should discuss with EMA the preferred approach  during the pre-submission meeting.  Having the methodology agreed with EMA no later than the pre-submission will help the trial sponsor avoid delays when delivering the Proposal and Final packages to EMA.

Contact Real Life Sciences

If you have questions or would like some consultation prior to starting your EMA Policy 0070, CTR or Health Canada PRCI project, please contact us directly at inquiry@rlsciences.com.  RLS has completed dozens of CDP/Policy 0070, Health Canada PRCI and other clinical transparency projects with pharmaceutical manufacturers of all types and sizes. 

For more information on Policy 0070 please visit our Policy 0070 overview page.


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