Streamline Clinical Data Publication Under EMA Policy 0070

Step 1 of the Policy 0070 restart applies to all new active substances receiving a Committee for Medicinal Products for Human Use (CHMP) opinion after September 2023. In a November 2024 webinar, EMA communicated its plans for Step 2 of the relaunch, scheduled for May 2025.

• The policy applies to all new marketing authorization applications (MAAs) that receive a positive or negative opinion. These include withdrawn applications, line extensions, and major clinical Type II variations (extension of indications).
• The policy excludes biosimilars, generics, and hybrid applications. These applications typically include minimal clinical data.
• There will be a continuation of the COVID publications and any new public health emergencies.
• The procedural timelines will remain as in Step 1 of the relaunch.
• EMA will collaborate more with stakeholders regarding anonymization strategy.
• Policy 0070 will align with Health Canada’s Public Release of Clinical Information initiative.
• Step 2 initially included individual patient data. However, they are not currently part of this step.

EMA is revising the External Guidance on EMA Policy 0070 surrounding the anonymization of personal and company information. Additionally, EMA will update the Questions and Answers (Q&A) document for drug developers in early 2025.

Clinical documents should not contain Commercially Confidential Information (CCI). Thus, there should be few, if any, CCI redactions in Policy 0070 submissions.

EMA will reject CCI redactions of information in the public domain. They will also reject redactions of entire paragraphs or pages. Applicants must justify each proposed CCI redaction. This justification should explain how disclosing this information would undermine the applicant’s economic interests.

EMA’s Notification to Marketing Authorization Holders

EMA will notify Marketing Authorization Holders (MAHs) three months before their CHMP opinion. This notification will include:

• the submission checklist,
• the list of in-scope documents,
• the anonymization report template and
• a link to the revised Q&A document.

Then, the MAH has two weeks to agree or disagree with the list of in-scope documents. As before, MAHs can request a pre-submission meeting with EMA to align on the scope.

EMA’s new Anonymization Report Form (ArF) template relies heavily on structured data. It uses 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. You can read more about the difference between anonymization and redaction of clinical trial data in this blog.

This structured format benefits applicants, regulators, and portal users. Creating ArFs with pre-populated fields and limited free text should be easier for applicants. Regulators expect easier reviews due to consistent formatting and content across applications. More concise ArFs should help portal users identify key information.

With the Policy 0070 restart, EMA has collaborated more with both internal and external stakeholders.

Internally, the Clinical Data Publication team is harmonizing its approach towards Protected Personal Data (PPD) and CCI with the Clinical Trials Information System (CTIS) team. They’re seeking to align requirements and messaging from both teams. This harmonization will help applicants meet regulator expectations and transparency goals.

Externally, EMA has enhanced its collaboration with Health Canada to allow efficient resource allocation and reduce administrative overhead. Both regulators will continue to accept packages that their counterparts previously accepted without any changes unless the documents differ. This mutual understanding depends on the following criteria:

• The sponsor submitted the MAA to both the EU and Canada
• At least 70% overlap between the EMA and Health Canada documents packages
• Regulatory opinion window between packages is 6 months

A single assigned regulator will review packages that fulfill these criteria. Consequently, this package should follow that regulator’s guidance. The respective regulator will review non-overlapping documents before publication.

After a coordinated assessment, the regulators will send one outcome to the MAH. This measure aims to decrease the administrative burden of creating, reviewing, and submitting two simultaneous packages to two different regulators.

Legacy clinical data refers to backlog data from MAAs submitted during the Policy 0070 suspension period. This has been a topic of discussion since the Policy 0070 relaunch. If EMA decides to publish these data, a vast volume of packages would need processing. At present, there are nearly 1,800 such packages.

EMA seeks to balance compliance and disclosure with resource availability. Thus, they don’t plan to release those legacy packages without a formal request for them. Legacy data requests go through the ‘Access-to-document’ web form, triggering a clinical data publication procedure.

EMA’s Policy 0070 restart marks a significant development in the Clinical Disclosure landscape. With the upcoming Step 2 expansion, applicants must stay updated on EMA’s evolving requirements. Sponsors also need to prepare for additional types of regulatory submissions to be included.

Certara has successfully supported clients with Policy 0070 submissions since the policy’s launch in 2015. Our Transparency and Disclosure team can help you plan for, prepare, and submit your Redaction Proposal Document Package to EMA.