In September 2023, the European Medicines Agency (EMA) reinstated its Policy 0070 requirement to publish all clinical studies submitted for regulatory approval. After almost five years of being offline (other than for COVID-19 submissions), the process and new standards that go along with Policy 0070 will likely be new to many sponsors looking to authorize their product in the EU.
This fall, we partnered with RAPS to share the following webinar with the drug development community, How to Plan for a successful EMA Policy 0070 submission. Given the extensive nature of the topic, the audience posed many great questions. We didn’t have a chance to answer all of them during the webinar. So, we’ve taken the opportunity to address them collectively through this blog post:
Does the EMA provide a checklist for all of the required documents for a Policy 0070 submission?
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.
When is the list of documents shared?
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.
Initial List of Expected Documents – Provided by EMA
Can protected-personal data (PPD) be redacted or is transformation the only option?
Both strategies are allowed, and there are pros and cons to each of them (read more about the differences between redaction and transformation anonymization methods in this blog). 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.
What software is used for risk assessment?
Certara uses our AI-enabled in-house software (learn more about our Clingenuity Redaction Management System here), as well as third-party software, depending on several factors including (but not limited to) budget, timelines, and size of the study. These software tools can provide comprehensive risk assessment and protect clinical trial data accordingly. The benefit of using software tools is automation, which allows for fast data processing and consistency in data treatment. The limitation is that software is only as good as the individuals using it. 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.) which, for the most part, an automated software tool can’t account for. Our team of Transparency & Disclosure specialists are experts at using these software tools and can address these limitations to efficiently and effectively protect personal, as well as commercial data.
What are the pros and cons of the qualitative vs the quantitative approach?
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 their inherent risk, while 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.
How does this policy affect European Union Clinical Trial Regulations (EU-CTR)?
Policy 0070 is for 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 prior to the marketing authorization application.
Will clinical study reports (CSRs) published under Policy 0070 also be published to EU CTR?
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).
What is the difference between Policy 0070, Policy 0043, and EU CTR?
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.
How early can I submit the Redaction Proposal Package?
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 CHMP opinion. The EMA has also stated that they are willing to proactively review CCI and the anonymization strategy PRIOR to submission upon request. This means that comments on CCI can be given before the submission of the Redaction Proposal Package, which could significantly speed up the review process. Specific procedural timelines can be found here.
The Process of Submission – Step by Step Process
How long will EMA take to review the redacted documents?
The entire review process (including any revisions) shouldn’t take longer than 84 days following the submission of the Redaction Proposal Document package. Specifics on the review and consultation process and timelines can be found in section 3.3.2. in the Policy 0070 Guidance.
How much time do we have to update revisions requested by the EMA?
If a revision of the redacted content is requested, the applicant has 7 days to provide a written agreement to the conclusion on the revisions, and another 7 days to revise the Anonymization Report, the CCI Redaction Control Sheets, or changes to the documents. Extensions have been requested and granted by other regulators. The EMA has expressed that they will attempt to accommodate applicants’ reasonable requests for extensions.
Does receiving feedback following the submission of the redaction package mean I will have to rewrite sections of the CSR?
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 additional information would have been requested by the regulator. The feedback following the submission of the Redaction Proposal Document package only concerns additional clarification on CCI and the data anonymization process (typically within the Anonymization Report).
How can I find a study on the EMA portal?
All EMA Policy 0070 publications can be found on their Data Sharing portal. To use this site, you must create an EMA account, which is free and gives you access to all publications that are searchable by key terms, product name, marketing authorization holder, active substance, and many other options.
Do you need help planning for your EMA Policy 0070 submission? Our Transparency & disclosure experts can help. Visit this webpage to learn more!