Draft guidance on terms and conditions for human and veterinary drugs: Progress reporting
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Progress reports
Although not required by regulation, we may request progress reports on the status of activities that are required by a term and condition (T&C). If requested, the progress report should include:
- the summary of outstanding conditions
- the status of the trial if applicable (pending, ongoing, delayed, terminated, submitted or fulfilled)
- details explaining the status and
- subsequent action taken to address the T&Cs
The progress report should be submitted by a date agreed upon at the time of the issuance of the T&Cs letter. If there are any questions regarding the content of the progress report, Health Canada will contact the MAH.
Progress reports will be requested on a case-by-case basis, and you will be informed directly if one is needed.
Sample report
This is a sample template that can be used to submit a report on the progress of ongoing trials.
Progress report: Submitted on [date]
Manufacturer or sponsor:
Product: [brand name] (active ingredients), route of administration, dosage form and strength, species (for veterinary drugs)
Submission and control number: NDS, SNDS, ANDS, SANDS (control number)
Terms and conditions letter date: Year/month/day
Description of trial:
Trial schedule (as applicable):
Protocol approval date; Trial enrollment start date and conclusion date; Last patient evaluation date; Health Canada submission date.
Current status:
Pending, Ongoing, Delayed, Terminated, Submitted, Fulfilled
Explanation of the status:
Brief description and action taken
Ongoing trial current status definitions:
- Pending: The trial has not been initiated by the market authorization holder (MAH).
- Ongoing: The trial is proceeding according to the original schedule or is ahead of schedule. The results of the trial have not been submitted to Health Canada.
- Delayed: The progress of the trial has fallen behind the original schedule. Examples of the delay status include difficulties in patient enrolment, delays in the analysis of the results, or delay in the filing of the submission to Health Canada.
- Terminated: The applicant ended the trial before completion, and has not yet submitted a final trial report to Health Canada. Examples of termination include termination of trial arms that are no longer feasible. For specific safety, efficacy or quality concerns related to the drug, Health Canada needs to be notified within 15 days.
- Submitted: The sponsor has submitted a final trial report to Health Canada, and the submission is currently in review.
- Fulfilled: Health Canada has conducted the review of the final trial report filed as a submission and has issued a notice of compliance to approve updated labelling indicating that the MAH has met the T&C.