Planning for a Successful EMA Policy 0070 Submission

Planning for a Successful EMA Policy 0070 Submission

Contributed Commentary by Honz Slipka, Certara

December 15, 2023 | European Medicines Agency (EMA) Policy 0070 requires the proactive publishing of clinical data submitted by pharmaceutical companies to support their marketing applications for human medicines under the centralized procedure. In other words, the EMA will publish anonymized documentation (with sensitive participant and company data protected) supporting the use of a drug on its public Clinical Data website so that anyone can read about medicines being authorized.

Policy 0070 was initially suspended when EMA relocated to Amsterdam post-Brexit. That suspension was extended during the pandemic, except for COVID-19 medicines. The policy is being relaunched in phases that began in September 2023. Now anyone submitting a Marketing Authorization Application (MAA), will also need to submit the required documentation to EMA Policy 0070.

Policy 0070 serves three important purposes:

Avoids duplication of clinical trials. You can check the website to make sure that no one has developed a similar drug or indication to the one you are planning.

Builds public trust in EMA’s scientific and decision-making process by being transparent and providing access to this information.

Permits the reassessment of clinical data by academics, researchers, and peers, which keeps everyone accountable, and helps to improve biomedical research.

EMA Review Process

Once a new drug has been developed and the clinical research completed, an initial MAA needs to be submitted to the EMA. A few months later, an invitation email will arrive, indicating that the decision on whether the product has been approved is coming. That is the time to begin working on the Redaction Proposal Document package.

About 210 days after the MAA is submitted, the Committee for Human Medicinal Products (CHMP), after having reviewed all the documentation, will provide a scientific opinion on whether the product can be authorized.

Regardless of whether it is a positive or negative decision, the clinical data must be submitted to Policy 0070. Therefore, the initial Redaction Proposal Document package can be created, and even submitted, before the opinion is received.

EMA will review the Redaction Proposal Document package to ensure that it complies with its guidelines, and that all protected personal data (PPD) is properly de-identified. The Agency will also review and comment on commercially confidential information (CCI) redactions, and the anonymization techniques used. It will then return the package, sometimes requesting that some of the documentation be reworked before the final piece is submitted for publication on the EMA’s Clinical Data website.

What must be included in the package for EMA review?

Cover letter and document checklist

Module 2 – clinical overview and clinical summary

Module 5 – clinical study reports, protocol, protocol amendments, sample case report forms, and statistical methods

Justification Tables – these explain why specific CCI was redacted and that it meets the EMA guidelines.

Anonymization Report – describes how PPD was de-identified in Modules 2 and 5.

Timeline Change

Since the relaunch, the timeline to submit the initial Redaction Proposal Document package has been increased from 40 to 60 days. But being prepared and able to submit the redaction packet early is important for a successful submission. The EMA usually has just 120 days after the CHMP opinion to publish the data on its website. However, there is some variability in timelines depending on the type of application.

Prepare Thoroughly

PPD – Be aware of the different redaction approaches, the standards that the EMA expects you to meet, and the reidentification risk thresholds. Being able to apply these techniques to the documents early will help to speed up the submission.

CCI – Learn from previous submissions, online resources, and industry experts. Develop a CCI library that contains all your company’s trademark information, and confidential company secrets, and then train your team how to use it. The best way to protect CCI is to only include information in the submission that is necessary to understand the clinical research. That removes the need to identify and redact it later.

Anonymization Report – Use the new three-page pdf template that was created by EMA and Health Canada. This template will make authoring the report much more efficient. Also, it is now possible to submit one Anonymization Report to both Agencies, which should help expedite the review process.

The template is very structured with tick boxes and dropdown menus and ensures that all the required content is properly presented in the report. You can select all the indirect identifiers in the documents, state whether they are for participants or personnel, and include the anonymization technique.

It also has handy, built-in notifications that pop up if you try to do something contrary to the EMA guidance, e.g., try to redact narratives or adverse event terms. They should save a lot of time. In the past, you had to submit the paperwork and wait for the EMA to review it before receiving the same feedback.

The EMA has also started sending out lists of expected documents to applicants to help reduce the likelihood of an incomplete submission.

Key Learnings

Pre-submission meetings with the EMA are tremendously useful. The EMA will request that you provide a list of questions and a couple of slides describing your progress in the process about one week in advance, so it can provide thorough answers. This is also an opportunity to discuss project-specific topics or timelines and deadline extensions.

Joint EMA/Health Canada Submissions

The EMA and Health Canada are working collaboratively on many drug submission-related issues, including Policy 0070. Their efforts have succeeded in enabling a joint submission for review by both Agencies.

Recommendations

Get started early, proactively plan for these submissions, and communicate openly with your team and the agencies. Focus on lean authoring and disclosure without exposure. If CCI is not included in the studies to begin with, it will not have to be redacted later. By following the tips and tricks recommended in this article, you will increase the likelihood of a successful EMA Policy 0070 submission.

Honz Slipka is a Transparency Specialist II on the Certara Transparency and Disclosure team. Honz has a research background in neuroscience and experience in health information technology. He is also an expert in data analysis, regulatory standards, and best practices in the field of clinical data privacy. He can be reached at honz.slipka@certara.com.