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:

  • Reviews and evaluates scientific information;
  • Considers advice from other experts (when deemed necessary);
  • Recommends the level of therapeutic improvement of the new patented drug product, and identifies drug products for comparison purposes and dosage regimens where possible; and
  • Identifies significant uncertainties in the evidence which may affect the analysis on which its recommendations are based.

HDAP is composed of six 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. Jacques LeLorier, 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 2019 are as follows:

  • February 25
  • May 27

The meeting dates for 2018 are as follows:

  • February 27
  • May 7
  • September 24
  • November 26

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:

  • One CD or memory stick must be filed within the HDAP submission deadlines
  • The CD or memory stick should be labelled according to the following naming convention: [Name of drug under review]
  • All documents must be provided in a single PDF document that is unlocked, searchable, and printable to enable users to extract information
  • The PDF document should be labelled according to the following naming convention: [Name of drug under review] Patentee Submission for the [Date of HDAP meeting] HDAP Meeting (e.g., Drug XX Patentee Submission for the May 4, 2015 HDAP Meeting)
  • Documents that have been merged into one PDF should be labelled and organized as indicated below. They must also appear in the following order and format in the PDF Bookmarks:

    A. Cover Letter

    B. Proposal of the Patentee – refer to Schedule 1 of the Guidelines for details on the required contents of the proposal. Do not include any price justification or pricing details; if this information is included, the submission will be returned to the patentee.

    C. References – please do not provide duplicate references or references that are not included in your submission. For the naming of articles/references, please minimize the characters used.

    1. Smith 2014
    2. (Company Name) Study
        a. Clinical Trial
        b. Relevant Findings

    Do not include the Product Monograph or Form 1. See Patented Medicines Regulations and HDAP schedule for the timelines for submission of Form 1 and the Product Monograph.
     
  • CDs or memory sticks should be mailed or couriered to:

    Regulatory Affairs and Outreach Branch
    Patented Medicine Prices Review Board
    Box L40, 333 Laurier Avenue West, Suite 1400
    Ottawa, Ontario K1P 1C1

Submission deadlines

2019 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 2019 are indicated below:

Monday, February 25, 2019
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 1, 2018
One electronic copy of patentee submission Thursday, November 29, 2018
Monday, May 27, 2019
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 10, 2019
One electronic copy of patentee submission Thursday, February 14, 2019

HDAP Meeting / Conference Calls for 2018:

February 27, 2018
Requirements Deadline

Form 1 – Medicine Identification Sheet

1 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)

November 7, 2017
1 electronic copy of patentee submission December 12, 2017
May 7, 2018
Requirements Deadline

Form 1 – Medicine Identification Sheet

1 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)

January 11, 2018
1 electronic copy of patentee submission February 15, 2018
September 24, 2018
Requirements Deadline

Form 1 – Medicine Identification Sheet

1 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)

May 10, 2018
1 electronic copy of patentee submission June 7, 2018
November 26, 2018
Requirements Deadline

Form 1 – Medicine Identification Sheet

1 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)

July 26, 2018
1 electronic copy of patentee submission August 23, 2018
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