Perspectives

4 Key Takeaways from the EMA – Health Canada Joint Review Process and Evaluation of Its Efficiency

The European Medicines Agency (EMA) and Health Canada (HC) now offer sponsors a joint pathway for marketing applications, streamlining the process across both agencies. This blog will discuss four key takeaways from our experience of submitting documents under the joint review option offered to one of our sponsors. It will also evaluate the EMA’s goal of achieving greater efficiency for sponsors by streamlining the separate review process required by both health authorities into one joint review. The joint review involves one agency taking on the role as the lead reviewer and the non-leading agency’s acceptance of the outcome.

Takeaway One: Receiving the Offer for a Joint Review

The EMA and Health Canada collaborate to identify marketing applications meeting the requirements for a single review.¹ While the Health Canada Public Release of Clinical Information (HC PRCI) anonymization process was already in progress, the sponsor received an offer from EMA offering the sponsor a joint review of the submission with Health Canada, with the EMA taking on the lead health agency role. This option was available to the sponsor after meeting submission requirements for a joint review: ¹

Submission packages were sent to both EMA and Health Canada by the sponsor.
At least 70% content overlap existed between the two submissions.
The marketing authorization applications were submitted within a six-month window between regulatory outcomes.

Takeaway Two: Establish Clear and Early Communication About the Joint Review’s Implications with the Sponsor

Once the sponsor accepted the joint review option, the documents initially anonymized per Health Canada PRCI guidance required re-evaluation against EMA Policy 0070 requirements, since EMA became the lead. This necessitated discussions with the sponsor to align on timelines, scope, and necessary document revisions.

Takeaway Three: Be Prepared for Changes in Lead Agency Requirements

Although the anonymization of the submission documents was started for Health Canada PRCI, the attention was now shifted to preparing documents for EMA Policy 0070. There were several changes that needed to be made for the submission documents:

Nomenclature Requirements: The nomenclature requirements for submitting EMA Policy 0070 documents require specific naming conventions given in the guidance² that must be followed for various study documents (e.g., naming conventions for pivotal and supportive studies, addendums, monotherapy and combination therapy, etc.) This naming convention is more complex than Health Canada’s -pr suffix after the document file name.³
Out of Scope Text Changes: There are distinct differences in the out-of-scope verbiage required for leaflets indicating removal of out-of-scope pages. Because the anonymization process began with Health Canada, all out of scope verbiage on the leaflets in the applicable submission files was changed to comply with EMA Policy 0070.²
Justification of Commercially Confidential Information (CCI): The proposed CCI on the redaction control sheet required by Health Canada PRCI³ for justifying all proposed CCI necessitated a transfer of the CCI to the required EMA Policy 0070 Justification Tables. Each standalone file containing proposed CCI (e.g., report body, protocol, statistical methods) required a separate justification table, unlike Health Canada’s single redaction control sheet.
Anonymization Form (AnF)⁴: The AnF was changed to include the EMA Procedure Number with N/A entered in the Health Canada Control Number field to indicate EMA as the lead agency. All other information did not require changes and was applicable to both health agencies.

Takeaway Four: Effective communication with both Health Agencies

Establishing a point of contact within both health agencies by the sponsor early in the process proved to be vital for outstanding questions regarding the joint review. Non-overlapping documents required from Health Canada (i.e., the non-leading agency) were confirmed and anonymized for the HC PRCI review.

Overview – Evaluation of Joint Review Efficiency

The joint review process was established between the EMA and Health Canada to bring efficiency to the review process for marketing applications that meet the requirements. The joint review benefits were presented in a November 2024 EMA-HC webinar :¹

Sponsors can prepare the submission packages for both EMA and Health Canada simultaneously.
One redaction proposal package is prepared and submitted to the lead agency.
The outcome of the review of the leading agency will apply for the non-leading agency.
Only non-overlapping documents are required for review by the non-leading agency.

The joint review collaboration led by the EMA, with the support of Health Canada, proved to be efficient. Instead of having to prepare two separate submissions containing all respective requirements in the documents for each health agency and waiting for two individual reviews and approvals, the sponsor was able to provide a single submission to the EMA for review with the input of Health Canada. The overlapping documents needing anonymization for Health Canada were quickly processed.

By implementing the four key takeaways presented in this blog, the sponsor will experience greater efficiency in joint reviews for future harmonized publications with reduced duplication of effort and recognition of both health agencies for approved submissions publication on both EMA Policy 0070 and Health Canada web portals. Ultimately, this streamlined approach helps accelerate the availability of new therapies to patients who need them most.

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