By now, most involved in the clinical trials disclosures field are aware of the upcoming reinstatement of the European Medicine Agency's (EMA) landmark transparency regulation: Policy 0070. Policy 0070 itself has been around for nearly a decade and is the European mechanism for publishing clinical data contained within a Marketing Authorization Application (MAA), a measure they refer to as 'exceptional transparency' and the 'key to reinforcing patient trust'.
Following a 5-year hiatus, the EMA will reintroduce the policy in a phased approach, starting in September 2023. The initial scope in this first phase will be new active substances (as described by Regulation 726/2004) adopted by the Committee for Medicinal Products for Human Use (CHMP), including products that ultimately receive a negative CHMP opinion or those that are withdrawn prior to receiving a CHMP opinion, as well as any COVID-19 related or other public health emergency medicines. Products previously authorized during the suspension of Policy 0070 are not within the scope, and the EMA has indicated that there are no plans to request clinical data for those products. Details of future phases and what will be in scope have not yet been released by the EMA, but it is anticipated that sometime in 2024, the Policy will be fully reinstated.
What's New in EMA Policy 0070?
During the "break”, the EMA took the opportunity to refresh the policy and make some updates. What does this mean for Marketing Authorization Holders (MAHs) and what has changed? At its core, the changes are primarily procedural and intended to improve efficiency and collaboration. At a high level, changes include updates to the cover letter and anonymization report template (AnR) as well as extension of timelines, both for the submission of the redaction proposal document package and the EMA's publication of the package. Nothing changes with respect to the overall review timelines by the EMA for the package; however, a technical "valid” submission will still be required to start the review clock.
A high-level summary of some of the changes:
- Redaction Proposal Package submission timelines: timelines have been extended for all types of packages, by 20 days for initial MAAs and extensions and by 30 days for withdrawn applications and Article 58 applications
- Redaction Proposal Package publishing timelines: packages were previously published within 60 days of issuance of Commission Decision; the packages will now be published within 120 days after CHMP opinion
- Cover Letter: the submission cover letter has been updated to include a mandatory checklist. The checklist was amended from what is available in the regulation to increase the probability of a valid first submission.
- AnR: updated in collaboration with Health Canada and is now mandatory; it brings many benefits to applicants, regulators, and portal users
- Deviation section: new section transferred directly from the Health Canada anonymization template. Any practices that deviate from the standards (e.g., full redaction of narratives) must be documented.
- Data utility: the most important personal data variables (up to 5) in the document package with the highest data utility (from a scientific perspective) must be listed and the impact of the anonymization (transformation or redaction) on these variables summarized.
Although not representing a specific change, the EMA 'doubled down' its position on the redaction of Company Confidential Information (CCI). The EMA expects there would be little to no data included within the clinical data packages that would be considered 'confidential' and in need of redaction, highlighting that for packages submitted in 2022, only 0.01% of data were redacted as CCI. MAHs should conduct a thorough review of all CCI, ensuring that none of the information already exists in the public domain. All proposed CCI is required to have detailed justification, including how the disclosure of such data would undermine economic interest.
In conjunction with other EU directives, the EMA has committed to increasing collaboration between the Policy 0070 team and the Clinical Trials Information System (CTIS) team to ensure consistency in the approach on both sides with respect to redaction of both CCI and personally protected data (PPD).
Looking Ahead
EMA has indicated it will begin sending invitation emails on 01 September 2023 to any MAHs with in-scope applications. Invitation emails should be received by procedure Day 121 and will include an updated Question & Answer (Q&A) document, a draft list of documents in scope for publication, and the new and improved submission checklist. Once the invitation email is received, MAHs are highly encouraged to take full advantage of the targeted pre-submission meetings offered by the EMA. This meeting is product-specific and is an opportunity to discuss and align with the EMA on scope (what documents are in scope, and which are not), strategy (anonymization approach to be applied), and CCI (what content is expected to be redacted as CCI and if it will be accepted).
Best practices for ensuring a smooth and successful submission:
- Create a Plan: preparation is key! Plan to begin preparation of the submission package as soon as the invitation letter is received and outline your strategy (what documents are in scope, will there be any other regulatory agency submissions for this package, what approach will you use [redaction or anonymization, or both])
- Be Proactive: reach out to EMA ahead of time to discuss any questions specific to your product and throughout the process
- Build a dedicated, cross-functional team: a clinical data package for redaction includes thousands of pages to be reviewed, having enough dedicated resources representing multiple functions will help ensure consistency and help with meeting timelines
- Pre-Work: identify any out-of-scope sections and mark appropriately to avoid any unnecessary work (and/or re-work)
- Quality: make sure you leave time for a thorough quality check prior to submission to ensure all documents in scope have been included
Get Help with Your Policy 0070 Preparation
ProPharma's highly experienced clinical trials disclosure team has reviewed and redacted thousands of pages across a variety of therapeutic areas in support of not only Policy 0070 submissions, but also Policy 0043, EU CTIS, and Health Canada Public Release of Clinical Information (PRCI). Our subject matter experts can help you prepare for the EMA meeting, develop an anonymization strategy, and manage the redaction of all in-scope documents. Our innovative redaction tool leverages AI to streamline the redaction process, building a repository of CCI, which increases efficiency and saves time. Combined with our highly experienced, best-in-class team, ProPharma can build a solution to help you expertly and efficiently submit a Redaction Proposal Document Package to the EMA.
Reach out to our experts today to see how our state-of-the-art automated redaction platform and seasoned team of experts can help you prepare for the relaunch of Policy 0070.
