Outstanding Responses to Additional Data Letters Interim Policy - Frequently Asked Questions

Questions

1. Why is Health Canada's Veterinary Drugs Directorate (VDD) proposing this interim policy on Outstanding Responses to Additional Data Letters (ADLs)?
2. What types of drug submissions will be affected?
3. Is there a deadline for submitting a reply to the Directorate's letter soliciting outstanding responses to ADLs?
4. How long will it take to complete the review of the additional data for a drug submission submitted to Veterinary Drugs Directorate (VDD)?
5. Under this interim policy, what will happen if I did not provide all the information that is required in the outstanding ADLs?
6. What submissions will be affected by this interim policy?
7. How will submissions be affected by this interim policy?
8. If a drug submission has been withdrawn because the related outstanding ADLs were overdue for more than 3 years, what does a sponsor need to do to have this information examined?
9. What is a refiled submission?

Answers

1. Why is Health Canada's Veterinary Drugs Directorate (VDD) proposing this interim policy on Outstanding Responses to Additional Data Letters (ADLs)?

The Veterinary Drugs Directorate currently has a significant number of submissions for which ADLs were sent to request additional or revised information in order to continue with the review of the sponsors submissions. There are over 200 outstanding ADL requests that have been in the system for more than two years.

VDD has determined that this situation has a serious impact on the validity of the data submitted especially if a response is received several years after the ADL is sent. This proposed interim policy outlines the circumstances under which VDD will handle submissions that have outstanding responses to ADLs.

2. What types of drug submissions will be affected?

This interim policy is to be implemented in three phases and will address the following types of drug submissions:

View the Interim policy Table

3. Is there a deadline for submitting a reply to the Directorate's letter soliciting outstanding responses to ADLs?

The sponsors will be given 90 calendar days to provide the required outstanding data following their receipt of the Directorate's letter soliciting outstanding responses to ADLs. No further extension will be granted.

4. How long will it take to complete the review of the additional data for a drug submission submitted to Veterinary Drugs Directorate (VDD)?

Since each case is different, the length of time that it will take to complete the review of the additional data will depend on the complexity of the data and whether or not the information submitted is considered satisfactory. The same process will apply as for any other drug submission.

5. Under this interim policy, what will happen if I did not provide all the information that is required in the outstanding ADLs?

It is the responsibility of the sponsors to provide all requested information to facilitate the review of their submissions. If a submission is incomplete, and additional information is not provided within the allotted time frame, the file will be considered withdrawn without prejudice.

6. What submissions will be affected by this interim policy?

This interim policy will affect any submission for which all applicable areas of review have been completed and where there is at least 1 outstanding ADL older than 1 year.

7. How will submissions be affected by this interim policy?

• If the oldest outstanding ADL was sent less than 1 year ago, VDD will continue to review the submission in accordance with current established procedure until such time as the ADL becomes 1 year old.
• If the oldest outstanding ADL is 3 years old or more, the submissions will be considered withdrawn without prejudice to refiling and the sponsors will be formally notified.
• If the oldest outstanding ADL was sent between 1 and 3 years ago,VDD will use a phased-in approach to address these submissions. This approach will allow VDD to maintain progress on daily operational activities while reviewing responses to outstanding ADLs.

8. If a drug submission has been withdrawn because the related outstanding ADLs were overdue for more than 3 years, what does a sponsor need to do to have this information examined?

The sponsor will need to resubmit his or her application along with the allotted fee.

9. What is a refiled submission?

A refiled submission is when a sponsor files another submission subsequent to the issuance of a submission withdrawal letter by the Veterinary Drugs Directorate. All refiled submissions will be processed as new submissions and will therefore be subject to new submission evaluation fees in accordance with Veterinary Drug Evaluation Fee Regulations.