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 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 2020 and 2021 are as follows:

• September 21, 2020
• November 23, 2020
• February 8, 2021
• May 31, 2021
• September 20, 2021
• November 22, 2021

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:

• The submission, filed through a commonly used and acceptable file sharing service, must be received within the HDAP submission deadline
• 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 - [Date of HDAP meeting] HDAP Meeting (e.g., [Drug Name] Patentee Submission - May 25, 2020 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.
   

• Notification of an online file submission should be sent by email to PMPRB.Regulatory-Reglementation.CEPMB@pmprb-cepmb.gc.ca, including any password if required.

Submission deadlines

2020-2021 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 2020-2021 are indicated below: