EMA & HC Guidance: Clinical Data Publication (CDP) – EMA Policy 0070 Work-Share with Health Canada

Sharan Murugan
15 hours ago
3 min read

The European Medicines Agency (EMA) continues to strengthen transparency, data sharing, and international regulatory collaboration through its Clinical Data Publication (CDP) framework. A key development in this area is the introduction of a work-share initiative with Health Canada (HC) under Policy 0070, aimed at improving efficiency while maintaining robust safeguards for sensitive information.

The guidance Clinical Data Publication (CDP): Questions and Answers on EMA Policy 0070 work-share initiative with Health Canada was published on 2 April 2026, providing detailed procedural clarifications for applicants participating in this collaborative framework.

Guidance: Clinical Data Publication (CDP) – EMA Policy 0070 Work-Share with Health Canada

This guidance provides a comprehensive question-and-answer framework on how clinical data are published under EMA Policy 0070 when a work-share process with Health Canada is applied. It focuses on improving efficiency, reducing duplication, and harmonising regulatory timelines, while ensuring that transparency and data protection requirements are maintained.

Background

EMA Policy 0070 governs the publication and access to clinical data for medicinal products for human use. It ensures that clinical study reports and related documents are made publicly available after regulatory decisions, supporting transparency and scientific scrutiny. The work-share initiative with Health Canada introduces a collaborative review mechanism, where both agencies jointly assess common documentation submitted in marketing authorisation applications.

This approach reduces duplication of effort for both regulators and applicants while maintaining independent regulatory decisions.

Scope

This guidance applies to marketing authorisation applicants (MAAs) submitting applications to both EMA and Health Canada who choose to participate in the voluntary work-share process. Currently, the work-share applies primarily to initial marketing authorisation applications where there is significant overlap in submitted documentation.

Work-Share Process

The work-share process is a voluntary collaborative review between EMA and Health Canada for procedures common to both agencies. Its main objective is to streamline the review and publication of clinical data by jointly assessing shared documentation. A lead agency is designated to coordinate the process, conduct the primary assessment of redaction packages, and act as the main point of contact for the applicant and the counterpart agency.

Eligibility Criteria

Participation in the work-share process requires that:

The applicant agrees to participate in joint review
Regulatory timelines for EMA and Health Canada are aligned within approximately six months
There is at least 70% overlap in submitted documents
Both agencies consent to the work-share

Participation is optional and does not affect standard procedures if not selected.

Submission Requirements

Applicants must provide:

Expected approval timelines for both agencies
Confirmation of participation
A List of Expected Documents (LED) identifying shared and agency-specific documents

This structured submission ensures clarity in distinguishing common and unique documentation across both agencies.

Package Preparation and Timelines

Applicants must prepare and submit Redaction Proposal Document Packages (RPDP) and Final Redacted Document Packages (FRDP) in line with standard EMA timelines.

The final package must include:

All required documents (common and agency-specific)
An anonymisation report
Approved redactions for commercially confidential information

The work-share process does not alter standard timelines but requires coordination between both agencies.

Anonymisation and Data Protection

Applicants must submit an anonymisation report (AnR) covering all documents to ensure that personal data are protected. The lead agency reviews the anonymisation strategy to confirm compliance with data protection principles and consistency across documents. Specific requirements include the redaction of handwritten information, as it may contain identifiable personal data.

Publication Process

After assessment, the applicant submits a final redacted package incorporating feedback on anonymisation, personal data protection, and CCI.

The lead agency publishes the clinical data first, followed by the other agency. Publication timelines align with standard CDP procedures and depend on the applicant’s ability to submit final packages to both agencies simultaneously.

Reuse of Documents

Applicants may reuse previously published documents, either from EMA or Health Canada, provided they inform the relevant agency during the process. This flexibility further reduces duplication and improves efficiency in regulatory submissions.