Questions and Answers - Management of Regulatory Submissions

1. When will Veterinary Drugs Directorate's (VDD) Management of Regulatory Submissions (MoRS) be implemented?

The VDD's MoRS will come into effect on July 1, 2005.

2. Which submissions and related correspondence/documents will be affected when the MoRS is implemented?

1. All submissions and related correspondence/documents received after July 1, 2005 will be subject to the MoRS.
2. All submissions and related correspondence/documents for which a letter of acceptance for review has not yet been issued (i.e., if it is still in the administrative or scientific screening stage), will be subject to the MoRS. This includes submissions for which there is an outstanding administrative or screening deficiency notice at the time of implementation.

3. What happens to submissions in progress at the time the MoRS is implemented?

1. Submissions with outstanding additional data letters (ADLs) will continue to be subject to the existing Additional Data Letter (ADL) policy. Subsequent Notice of Deficiencies (NOD) issued after July 1, 2005 will be subject to the MoRS.
2. For existing submissions, accepted for review but for which the review has not been completed, the VDD will endeavour to uphold the intent of the MoRS i.e., synchronize the review streams and issue a single NOD if necessary. However, if the different review streams for a submission are projected to be completed more than 90 days apart, separate NODs will be issued for the submission.

4. Will VDD continue to accept phased submissions?

July 1, 2005, VDD will no longer accept new phased submissions. If a phased submission is received after that date, it will be returned at the applicant's expense.

5. What will happen with phased submissions for which not all phases have been submitted?

Sponsors may submit the remaining phases as originally planned. One year after the MoRS implementation, VDD will re-evaluate its position on outstanding phases of phased submissions to determine whether a request will be sent to sponsors to submit outstanding portions. It should be noted that phased submissions will not be subject to performance targets.

6. The MoRS does not describe a process for appeal/reconsideration, where can one find that information?

The reconsideration process will be described in a separate document. VDD has already published a Blueprint for the Veterinary Drug Submission Appeal Process. A more detailed document dealing with reconsiderations is currently in preparation.

7. How will submission types not covered in the MoRS be managed?

VDD has chosen to put emphasis on the submission types where the longest backlog existed. All other submission types will be covered in a second release of the MoRS already underway. A draft of the second release will be posted for consultation in the third quarter of this fiscal year.

8. What guidance will be provided to sponsors to help them prepare quality submissions and thus reduce the likelihood of deficiency notices?

VDD is committed to supporting sponsors in preparing quality, complete submissions. VDD will conduct, as required, workshops or training sessions to help sponsors in the preparation of submissions. VDD is encouraging sponsors to hold pre-submission meetings in order to clarify issues before the submission is filed. The guidance for the Preparation of New Drug Submissions developed in parallel to the MoRS will also significantly help sponsors. The development of additional documents is planned for the future.

9. Will I be able to contact the evaluators assigned to review my submission(s)?

VDD will not provide sponsors with the names of evaluators assigned to their submission(s). Should sponsors have any questions or concerns regarding their submission, they should contact the Submission Office by phone at (613) 941-8845 or by fax at (613) 946-1125.

10. My submission has been accepted for review and has been in the queue for some time now. Will I receive an Update Notice, and if so, how do I go about updating my submission?

VDD will issue Update Notices for submissions which have exceeded targets published in the MoRS and for which a review has not been initiated or is expected to begin in the near future. If your submission qualifies, you will be invited to inform VDD's Submission Office in writing of your intent to provide updated data on your submission, and must provide the updated data within 60 days of issuance of the Update Notice. Any updated data should be provided in a binder format, replacing existing binders as necessary. VDD will destroy replaced data binders as per established Health Canada procedure, or return them to the sponsor at their request and expense.

Loose leaf information with instructions on how to insert pages into existing binders will not be accepted. Sponsors should review the scope of data VDD will accept in an Update Notice in the MoRS. Sponsors should also note that unsolicited data, with the exception of a safety information update, will not be evaluated and will be returned to the sponsor at their expense.

11. What is the timeframe for submission holds?

A timeframe is provided for submission holds during the administrative screening phase (15 days), however a timeframe cannot be defined for submission holds resulting from issues such as patent issues, outstanding regulatory issues or scheduling switches. Neither the sponsor nor VDD have control over the length of time required to resolve such issues.

12. When does VDD intend to meet its performance targets as stated in the MoRS?

The following is a summary table of VDD performance targets and the projected fiscal year when they will be met:

Previously, VDD targeted to issue decisions on 90% of data packages greater than 24 months old as of April 1^st, 2003, and to issue decisions on data packages greater than 18 months old as of April 1^st, 2004. VDD successfully met these targets.

For NDS, ABNDS, SNDS and SABNDS submissions, VDD has committed to issuing a decision on 90% of data packages more than 12 months old as of April 1^st, 2005.

In fiscal year 2007-2008 VDD expects to begin meeting the published SNDS and SABNDS targets, followed by meeting published NDS and ABNDS targets in fiscal year 2008-2009.