HDAP Meeting Schedule and Filing Requirements

The Human Drug Advisory Panel (HDAP) provides expertise and advice to Board Staff in conducting the scientific review. HDAP performs the following functions:

HDAP is composed of five members with recognized expertise in drug therapy who have experience in clinical research methodology, statistical analysis and the evaluation of new drug products. The members are: Dr. Fred Aoki, Dr. Peter Jamieson, Dr. Muhammad Mamdani, Dr. Michael Rieder and Dr. Adil Virani.

For further information on the HDAP and the scientific review process, please refer to Part C, Scientific Review Process, Compendium of Policies, Guidelines and Procedures.

HDAP meets four times a year.

The currently scheduled meeting dates for 2021 and 2022 are as follows:

In order to provide for fairness to the patentee, assurance that a drug product will in fact be scheduled for discussion at a meeting and to also expedite the process, Board Staff requires that a patentee file a product monograph or information similar to that contained in a product monograph before the scheduled meetings.

A patentee wishing to make a submission with respect to the level of therapeutic improvement, the selection of drug products and dosage regimens to be used for comparison purposes must make its submission no later than the patentee submission deadline set out below for the particular HDAP meeting. For more information on what should be included in a submission, please refer to the Schedule 1, Submissions by Patentees on Level of Therapeutic Improvement, Compendium of Policies, Guidelines and Procedures.

Requirements for filing electronic submissions

All patentee submissions must be filed electronically. The requirements are as follows:

Submission deadlines

2021-2022 Human Drug Advisory Panel Meetings

The Human Drug Advisory Panel (HDAP) provides credible, independent, and expert scientific advice to Board Staff in conducting scientific reviews of information submitted by patentees. The meeting date and submission deadlines for the currently scheduled meetings of the HDAP in 2021-2022 are indicated below:

Monday, February 8, 2021
Requirements Deadline

Form 1 – Medicine Identification Sheet

One copy of product monograph or information similar to that included in a product monograph (if product has not yet been approved for sale in Canada)

Thursday, November 12, 2020
One electronic copy of patentee submission Thursday, December 3, 2020
Monday, May 31, 2021
Requirements Deadline

Form 1 – Medicine Identification Sheet

One copy of product monograph or information similar to that included in a product monograph (if product has not yet been approved for sale in Canada)

Thursday, January 21, 2021
One electronic copy of patentee submission Thursday, February 18, 2021
Monday, September 20, 2021
Requirements Deadline

Form 1 – Medicine Identification Sheet

One copy of product monograph or information similar to that included in a product monograph (if product has not yet been approved for sale in Canada)

Thursday, June 3, 2021
One electronic copy of patentee submission

Tuesday June 29, 2021

Monday, November 22, 2021
Requirements Deadline

Form 1 – Medicine Identification Sheet

One copy of product monograph or information similar to that included in a product monograph (if product has not yet been approved for sale in Canada)

Thursday, August 5, 2021
One electronic copy of patentee submission Thursday, September 9, 2021
Monday, February 14, 2022
Requirements Deadline

Form 1 – Medicine Identification Sheet

One copy of product monograph or information similar to that included in a product monograph (if product has not yet been approved for sale in Canada)

Thursday, November 4, 2021
One electronic copy of patentee submission Thursday, December 2, 2021
Monday, May 16, 2022
Requirements Deadline

Form 1 – Medicine Identification Sheet

One copy of product monograph or information similar to that included in a product monograph (if product has not yet been approved for sale in Canada)

Thursday, January 20, 2022
One electronic copy of patentee submission

Thursday, February 17, 2022

Report a problem or mistake on this page
Please select all that apply:

Thank you for your help!

You will not receive a reply. For enquiries, contact us.

Date modified: