Pre-Clinical Trial Application (CTA) Consultation Meeting

Health Canada invites sponsors to request a pre-CTA consultation meeting. Such consultations may be particularly useful for new active substances or applications that will include complex issues that may be new to Health Canada.

The pre-CTA consultation meeting provides an opportunity for the sponsor to present relevant data, discuss concerns and resolve issues regarding drug development. It also gives Health Canada an opportunity to provide guidance on the acceptability of the proposed trial(s). Sponsors may invite the qualified investigator(s) who will be involved in the proposed trial(s) in Canada to attend the meeting.

Request for a Pre-CTA Consultation Meeting

Requests for a pre-CTA consultation meeting should be submitted in writing by the sponsor to the appropriate Directorate .

Requests should be submitted in the form of a cover letter, proposing 4 dates and times suitable for a pre-CTA consultation meeting. The cover letter should also be accompanied by the following information:

• A brief synopsis of the proposed study,
• A list of questions to be addressed by the Directorate during the meeting,
• Identification of specific areas (e.g. consultation with members of the Quality Division), if needed.

The Directorate will acknowledge the request for consultation. If the Directorate agrees with the request, the acknowledgement letter will indicate the number of copies of the pre-CTA information package to be provided and confirm the pre-CTA consultation meeting date.

Preparation of the Pre-CTA Information Package

The information package should be provided to the appropriate Directorate 30 days prior to the meeting date.

A pre-CTA information package should contain the following information:

• Proposed agenda, any prepared slides, and a complete list of attendees [it is recognized that the slides may change prior to the meeting, but it is still requested to include the preliminary slides in the package]
• Brief summary of all data including
  • tabular listing of completed preclinical and clinical studies
  • an outline of the observed toxicological manifestations and a discussion of their impact on the use of the drug in humans
  • an outline of the observed adverse events and a discussion of potential safety problems
• Proposed global clinical plan for the current stage of drug development including regulatory status in other countries [it is recognized that this plan is subject to change as new information becomes available]
• Details of the proposed clinical trial(s) to be conducted in Canada, within the scope of the intended CTA, including
  • statement of trial design
  • parameters, values, ranges or limits for indication(s) and clinical use(s), patient study population(s) and routes of administration
  • parameters, values, ranges or limits for dosage form(s), dosage regimen(s) and formulation(s)
  • proposed procedures and/or criteria for patient monitoring, clinical efficacy and safety assessments, alternative treatments, premature patient discontinuation and other considerations, as appropriate
• Summary of significant Quality (Chemistry and Manufacturing) aspects of the drug.
• For Biologics and Radiopharmaceuticals
  • A listing of all production site(s)
  • a summary of the method of manufacture for both drug substance and dosage form
  • relevant flow charts
  • a listing of quality control procedures and specifications
  • a summary of product characteristics

Should the pre-CTA package be found deficient, the sponsor may be requested to reschedule or postpone the meeting to allow the sponsor to assemble a more thorough package. Please note that the Directorate has the right to modify or truncate the proposed agenda as it sees fit to better achieve the stated goals of the meeting.

Pre-CTA Consultation Meeting Records

The sponsor should prepare and send to the appropriate Directorate a written record of the discussions and conclusions of the consultation meeting within 14 days of the consultation date. All records of this consultation will be added to the Central Registry (CR) file for the drug.