United Kingdom-Canada Regulatory Cooperation: Guidance on Veterinary Drug Simultaneous Reviews

Table of Contents

• 1. Purpose
• 2. What is a simultaneous review?
• 3. Eligible products
• 4. Phases of a simultaneous review
  • 4.1 Pre-submission phase
    • Expression of interest
    • Pre-submission discussions
    • Decision on admissibility
    • Timelines for review
  • 4.2 Submission filing phase
    • Coordinated filing
    • Submission completeness check
  • 4.3 Submission review phase
  • 4.4 Sovereign decision
• 5. Additional considerations
• 6. Contact information

1. Purpose

The purpose of this document is to outline the process for the simultaneous review of veterinary drug submissions by Health Canada's Veterinary Drugs Directorate and the United Kingdom's (UK) Veterinary Medicines Directorate. Note that guidance documents are administrative instruments not having the force of law.

Simultaneous reviews offer the following benefits without compromising domestic standards and scientific rigour:

• Simultaneous access to two major markets for veterinary drug manufacturers
• More choices for animal owners and food producers by supporting faster access and expanding the number of treatment options available
• A stronger global review community that allows regulators to work across jurisdictions to share knowledge and expertise
• Independent, sovereign decision-making by each regulator while striving for harmonization

2. What is a simultaneous review?

Simultaneous reviews permit manufacturers to submit a dossier to both regulators at the same time. The evaluation is conducted independently by each country in parallel, with the objective of issuing regulatory decisions at the same time. Submissions also must meet all applicable national requirements.

3. Eligible products

Submissions may be for new veterinary medicinal products, or for new uses of existing products that already hold marketing authorizations in both countries, provided they have not been subject to relevant or significant safety-related regulatory action in either country. In Canada, this includes New Drug Submissions and Supplements. The product must be identical in formulation and manufacturing, including the source of the active ingredient. There may be differences in product labels. Currently, this opportunity is only open to applications which are based on a full dossier (i.e. containing all applicable technical information for safety, efficacy and quality).

New biologic entities and bio-similars will be handled on a case-by-case basis depending on the regulatory authority. Submissions for drugs for minor uses/minor species (MUMS) are especially encouraged.

Generic drugs are not eligible for review under this pathway at the present time. Veterinary Health Products (in Canada) and products exempted from authorization in the UK are also not eligible.

4. Phases of a simultaneous review

4.1 Pre-submission phase

Expression of Interest

Early interactions by industry with the regulators are important, and will assist in the process to assess the feasibility and admissibility of a submission. Applicants are encouraged to contact the UK VMD and VDD to learn more about this process and initiate dialogue with the regulators. Applicants may signal their interest by sending an expression of interest to both regulators at the earliest opportunity.

The expression of interest should also include a request for a pre-submission discussion. The request should, as a minimum, provide basic information on the proposed product and indicate the scientific disciplines that the applicant wishes to discuss, as well as any specific issues/questions to be addressed by the regulators, although questions concerning scientific advice would be considered outside of this process. The regulators will then jointly work with the applicant to schedule these discussions.

The expression of interest should also include authorization from the applicant to the regulators to permit the exchange of relevant information.

Pre-submission discussions

Pre-submission discussions are required to inform a decision on admissibility. This meeting is of a scoping/exploratory nature. The purpose of a pre-submission discussion where presentations are made by the applicant to the regulators is to introduce their new drug product and to discuss whether it is a good candidate for this process.

Joint pre-submissions are strongly recommended. These meetings should involve the applicant, including its representatives in both countries, and both regulators at the same time. If not possible, applicants may also have pre-submission meetings with each country individually.

Discussions can confirm and clarify data requirements and product testing, address submission formatting, and provide feedback from regulators on study protocols proposed by applicants. The discussions are also an opportunity to clarify any national requirements.

The applicant is responsible for proposing an agenda in advance of the meeting, recording the meeting notes and seeking any comments, clarifications or corrections from meeting participants in a timely manner; revised and finalized meeting notes should be shared with the regulators for approval and future reference.

Decision on admissibility

If a submission is deemed to be an appropriate candidate, the regulators will request a formal letter from the applicant seeking a collaborative review.

Based on the information gathered through the pre-submission discussions and the formal request from the applicant, the regulators will consider a variety of factors before deciding to proceed. The regulators will communicate the decision on admissibility to the applicant via formal letters.

Timelines for review

Both regulators will aim to issue decisions at approximately the same time. Review timelines will be based on the UK performance standard. Both regulators will aim to reach a final decision to approve or refuse within 210 days of the date it is accepted into review. Timelines should be confirmed with the regulators prior to filing but the UK national complex MA timetable may be used as a guide for the initial assessment to sign-off stage.

4.2 Submission filing phase

Coordinated filing

Applicants must file separate submissions to both regulators independently and simultaneously. Applicants are to file their submission to each country using the available national electronic tools (i.e., REP in Canada, and VMD Digital Services in the UK).

All submissions must meet all applicable national regulatory and administrative requirements.

The content of the submissions should be the same, including nation-specific technical requirements. There may also be nation-specific administrative documentation or fees payable, as per national regulatory requirements, policies or processes. Applicants are encouraged to confirm applicable fees with both regulators prior to submission.

Applicants are to submit in the UK dossier format to both countries. They should also submit a crosswalk to the Canadian table of contents to help demonstrate regulatory requirements are met and Canadian reviewers can find the necessary information. The crosswalk should clearly indicate the location of the technical sections and highlight country-specific deviations.

To enable the review process, data and other information (including confidential business information) provided by the applicant will be discussed by the regulators. Applicants are asked to provide a letter authorizing this exchange of information.

Submission completeness check (screening/validation)

Each regulator will perform a screening or validation of the submission to ensure that the submission can be accepted for review.

If the regulators have questions about the content of the submission during screening/validation, they will send it to the applicant with a copy to the other regulator. The applicant should submit their responses, including any associated documentation, to both regulators simultaneously. It is the applicant's responsibility to ensure that both regulators have an updated consolidated dossier at the end of validation/screening so both countries are working on identical dossiers and no data are missing.

At the end of screening/validation, each regulator will send a communication to the applicant informing them of the acceptability of the submission for review.

4.3 Submission review phase

Regulators will meet to discuss the submission, including lists of questions (also referred to as clarification requests). Regulators will also meet throughout the submission process.

Lists of questions from both regulators may be combined or issued separately. Applicants will be provided with an established amount of time in which to submit completed responses, which should be confirmed with the regulators. Applicants are expected to share their responses to all questions with both regulators.

Opportunities to harmonize maximum residue limits (MRLs) and better alignment of labelling will be considered.

If the applicant is seeking to meet with one regulator at any point during the submission review process, it is incumbent upon them to inform and invite the other regulator to participate.

4.4 Sovereign decision

Each regulator makes its own sovereign decision in accordance with relevant national legislation.

Each regulator will undertake the necessary national administrative and/or legal steps relating to the issuance of a market authorization or negative decision. To the extent possible, regulators will synchronize the timing and communication related the issuance of decisions.

In the event of a negative decision by one or both regulators, the applicant is encouraged to discuss available options and the administrative process to address deficiencies with the regulator(s), based on their regulatory frameworks. Note that relevant national reconsideration/procedural fairness processes apply.

5. Additional considerations

Should an applicant wish to withdraw a submission from review, they are encouraged to contact both regulators at the earliest opportunity prior to cancellation to discuss any concerns and regulatory considerations.

Once a product has received market authorization, it is the responsibility of the applicant to adhere to all applicable national post-market regulatory requirements. Regulators will continue to collaborate and exchange information to support post-market monitoring, risk assessment and risk management activities, as appropriate.

6. Contact information

For more information, contact:

Canada

International Liaison Officer
Veterinary Drugs Directorate
Health Products and Food Branch
Health Canada
Email: hc.vdd.international-international.dmv.sc@canada.ca

United Kingdom

Head of Licensing Administration and General Assessment
Veterinary Medicines Directorate
Email: postmaster@vmd.gov.uk