On 16 May 2023, the European Medicines Agency (EMA) held a webinar to announce plans to restart the publication of clinical data contained in regulatory submissions under Policy 0070. The Policy was originally suspended in 2018 as part of EMA’s Business Continuity Plan for its relocation in the wake of Brexit (read about it in this blog). The suspension remained in effect throughout the COVID-19 pandemic, except for the exceptional transparency measures for COVID-19 medicines. Now, nearly five years later, EMA is ready to restart Policy 0070 with a phased approach beginning in September 2023.
Five Key Takeaways
EMA intends to post a replay of the webinar and the slides presented on the event web page. However, as of the date of this blog post, those materials are not yet available. For those who couldn’t attend the live webinar, here are five key takeaways.
What is in-scope for the relaunch?
Phase 1 of the Policy 0070 restart will apply to all new active substances receiving an opinion from the Committee for Medicinal Products for Human Use (CHMP) in September 2023. This includes products receiving approval, products receiving a negative decision, and withdrawn products.
In Phase 2, EMA plans to broaden the scope to include additional procedure types, but details of those plans are not yet available. Just as important for many applicants, EMA stated they have no plans to request clinical data for products authorized during the suspension of Policy 0070.
Renewed focus on limiting CCI redactions
EMA reiterated their expectation that clinical documents should not contain Commercially Confidential Information (CCI), and thus there should be very few, if any, CCI redactions in documents submitted under Policy 0070 (read about CCI and CBI; confidential business information in this blog).
To emphasize this point, EMA discussed the metrics for the 46 COVID-related procedures processed during the suspension. Of those 46 procedures, EMA accepted CCI redactions in only 3 of them across a total of only 21 pages. This represents an overall CCI acceptance rate of just 0.01%.
EMA emphasized that CCI redactions of information already in the public domain will be rejected, as will redactions of entire paragraphs or pages. They also reminded applicants that a detailed justification must be provided for each proposed CCI redaction, including precisely how the applicant’s economic interest would be undermined if the information were to become public.
Timelines
For the restart of Policy 0070, EMA will initiate the process as early as procedure day 121 with the expectation of receiving the Redaction Proposal Document Package within 30 days of the CHMP opinion.
EMA recommends that applicants prepare packages early to ensure that packages are submitted, reviewed, and published within the established timelines. EMA will support this initiative through several actions.
- Applicants will receive an invitation email by procedure day 121 inviting them to engage with EMA and begin creating the Redaction Proposal Document Package (approximately 90 days from when the package will be due).
- EMA will draft a list of in-scope documents for applicant agreement.
- EMA will hold pre-submission meetings with applicants to answer questions and align on the in-scope documents.
- EMA will publish more guidance documents to assist applicants with the process, including an updated Question & Answer document.
New Anonymization Report template
EMA is developing a new Anonymization Report (AnR) template that relies heavily upon structured data. It will employ tick boxes, drop-down lists, data tables, and limited free text fields to collect information on the anonymization strategy, risk assessment, data utility, and deviations (read more about the difference between anonymization and redaction of clinical trial data in this blog).
This structured format promises many benefits to applicants, regulators, and portal users. For applicants the creation of AnRs should be easier with the pre-populated fields and limited free text. Regulators expect to gain efficiency in their review process from consistent formatting and content across all applicants. Portal users should benefit from more concise AnRs that better facilitate the identification of key information.
At the time of the webinar, an example of the new AnR template was not yet publicly available; however, EMA intends for the new template to be available for applicants to use by the September 2023 restart.
More collaboration
In conjunction with the Policy 0070 restart, EMA has increased its collaboration with both internal and external stakeholders.
Internally, the Clinical Data Publication team is working to harmonize the approach towards Protected Personal Data (PPD) and CCI with their colleagues on the Clinical Trials Information System (CTIS) team (read more about CTIS in this blog). Their goal is to ensure aligned requirements and messaging from both teams, making it easier for applicants to consistently meet regulator expectations and transparency goals.
Externally, EMA has enhanced their collaboration with Health Canada (HC; read about the partnership here). EMA will expand the option of joint EMA/HC reviews of procedures for COVID-19 medicines to all procedures in-scope for the restart. These joint reviews will be facilitated by the new AnR template, which has been jointly developed by EMA and HC.
Final Thoughts
EMA’s restart of Policy 0070 is arguably the biggest news in the Transparency and Disclosure space in quite some time. It will present a significant challenge for many applicants, especially those who have not been through a Policy 0070 submission previously. Certara has successfully supported clients with Policy 0070 submissions since the policy’s original launch in 2015, including recent support for COVID-19 medicines during the suspension period. Our team of dedicated Transparency and Disclosure professionals stand ready to help you plan for, prepare, and submit your Redaction Proposal Document Package to EMA.
Learn more by watching the webinar we produced with RAPS on this topic.
