Draft guidance on human and veterinary drug submissions based on promising evidence and terms and conditions: Before filing a submission
On this page
- Before filing a new drug submission or supplement to a new drug submissions for human and veterinary drugs based on promising evidence of efficacy
- Pre-submission meeting
- Advance consideration of human drug submissions filed with promising evidence of efficacy
- Denial of a request for advance consideration of a human drug submission filed based on promising evidence of efficacy
- Revised request following denial of a request for advance consideration of promising evidence status for a human drug submission
- Assessment of information in pre-submission meeting package
- Additional information to be provided
Before filing a new drug submission or supplement to a new drug submission for human and veterinary drugs based on promising evidence of efficacy
We ask that manufacturers request a pre-submission meeting in advance of filing a new drug submission (NDS) or supplement to a new drug submission (SNDS) for human and veterinary drugs seeking market authorization of their drug, on the basis of promising evidence of clinical efficacy.
Pre-submission meeting
Manufacturers should submit a pre-submission/application meeting package in one of the acceptable file formats.
For more information on the pre-submission meeting process, refer to:
- For human drugs: Guidance on management of drug submissions and applications
- For veterinary drugs: Management of regulatory submissions
Veterinary drugs – Pre-submission
For veterinary drugs, manufacturers should submit a pre-submission meeting package at least one month in advance of the meeting. In addition to the information to be included in the pre-submission meeting package as per the Management of regulatory submissions guidance, the following information should be provided as an appendix to the pre-submission package:
- A summary of studies completed to support the promising evidence
- How the product meets the criteria for a serious or severely debilitating disease or condition
- The status of ongoing studies aimed to support clinical effectiveness of a drug product, including anticipated completion dates
- A plan for completing all ongoing studies
- A timeline for filing of the submission based on promising evidence
We will notify the manufacturer if a NDS or SNDS contains the necessary information to be considered as a submission based on promising evidence of efficacy within 14 calendar days after the pre-submission meeting minutes are finalized.
Unless otherwise agreed to in the pre-submission meeting, submissions should be filed within 6 months of receiving this confirmation, or a new pre-submission meeting may be required. A copy of this confirmation should be included in the submission.
Advance consideration of human drug submissions filed with promising evidence of efficacy
Manufacturers may seek a shorter screening and review target for their drug submission by requesting advance consideration of promising evidence (ACPE) status. ACPE status will be granted for submissions based on promising evidence if specific criteria are met. Refer to the following in this guidance:
- For human drug submissions granted advance consideration
- Request for advance consideration of promising evidence template for human drugs status
Manufacturers should state within their pre-submission meeting request that they are seeking ACPE status. The request for ACPE template is to be completed and filed at the same time as the filing of the pre-submission meeting package. We will use the completed request as part of the initial assessment to determine if the drug submission will be granted a reduced screening and review targets.
We will grant or deny a request for ACPE status based on the assessment of the information provided in the ACPE template, the pre-submission meeting package and the pre-submission meeting minutes. We will inform manufacturers of our decision within 14 calendar days of receipt of the final pre-submission meeting minutes by the review bureau. This will be communicated to manufacturers through the issuance of an acceptance or denial letter for ACPE.
If ACPE is granted, the drug submission will be referred to as a drug submission based on promising evidence and will be subject to reduced screening and review targets.
The sponsor should clearly state in their cover letter when filing the drug submission that it has been granted ACPE. A copy of the acceptance letter should be included. The submission should be filed within 60 calendar days of the date of the acceptance letter (Figure 1).
We encourage manufacturers who file drug submissions to work with us and the relevant health technology assessment organizations on an aligned review:
- Canada's Drug Agency (formerly Canadian Agency for Drugs and Technologies in Health or CADTH)
- Institut national d'excellence en sante et en services sociaux (INESSS)
For additional information related to the aligned review process, refer to:
Denial of a request for advance consideration of a human drug submission filed based on promising evidence of efficacy
We may deny a request for ACPE of a drug submission based on promising evidence of efficacy for reasons such as:
- the drug does not meet the criteria listed in the section C.08.003.2 of the Food and Drug Regulations (regulations)
- failure to provide a completed ACPE template
- failure to adhere to the required filing procedures listed in section on before filing a drug submission with promising evidence of efficacy in this guidance
If the request for ACPE status is denied and a submission is filed, the submission screening and review targets will not be reduced.
Revised request following denial of a request for advance consideration of promising evidence for a human drug submission
If we deny a request for ACPE, the manufacturer has 30 calendar days from the date of the decision letter to file a revised request for ACPE. The document must clearly denote the new information submitted (for example, new results for ongoing clinical studies). Failure to provide new information will result in denial of the request. Health Canada will review the revised request for ACPE within 30 calendar days and will communicate its decision through the issuance of an acceptance or denial letter.
If we deny the revised ACPE request, no further requests based upon the same proposed indication for the drug will be considered for an ACPE.
Assessment of information in pre-submission meeting package
We will consider the current standard of care, which may or may not be the same as that used in the relevant clinical study in the planned NDS or SNDS when assessing the pre-submission meeting package as well as the information presented at the pre-submission meeting, and the ACPE request in the case for human drugs. The onus is on the manufacturer to provide a robust rationale for the selection of the comparator and to analyze the comparative benefit-risk profiles in the context of the current standard of care.
Additional information to be provided
Following a pre-submission meeting, and if ACPE status is granted for human drugs, the manufacturer is asked to include the following in their NDS or SNDS submission package, if available:
For human and veterinary drugs:
- Annual Summary Report (or similar safety update report, such as PSUR [for human and veterinary drugs] or PBRERs [for human drugs])
- Copies of foreign review assessment reports
- Copies of labelling for the drug product approved in other regulatory jurisdictions
- A complete listing of ongoing additional clinical trials related to the proposed indication
- A summary of the international regulatory status of the drug, including:
- ongoing requests for market authorization in other jurisdictions
- market withdrawals in other jurisdictions, along with reasons (for example, serious safety concerns, commercial reasons)
- Any existing marketing authorizations for the drug under review in foreign regulatory jurisdictions
In addition to the above, for human drugs only:
- Periodic Benefit-Risk Evaluation Reports (PBRERs)
- Copies of approved Pediatric development plans from other regulatory jurisdictions
- Copies of approved Risk Management Plans (RMPs) from other regulatory jurisdictions, if applicable
For information on RMPs, refer to: