Rights Holder Input Relating to the Scientific Review Process

Once notified that a patented medicine has been identified for In-Depth Review, a Rights Holder (RH) may choose to provide written input relating to the Scientific Review portion of the process (see par. 87 of The PMRPB Guidelines for Staff).  To assist RHs in identifying relevant materials, and to ensure optimal use of resources, the following guidance is provided.  Please note that this information is above and beyond the information provided in the Form 1, and accompanying Product Monograph (or similar information if the medicine has not yet been granted a Notice of Compliance).

Rights Holders wishing to make a submission are encouraged to include the following content for each indication under review:

• Cover letter, including name of primary contact person within the Rights Holder’s organization.
• Proposal of the Rights Holder
• Information about the medicine under review: generic name, class, brief description of mechanism of action, approved indication(s) or use(s), and approved or proposed dosing.
• A summary of trials included in the submission organized in a tabular format.  The table should identify:
• The study author(s) or identifiers (e.g. NCT trial number), date and corresponding publication information, if applicable;
• Brief description of the study;
• Trial Phase (i.e., Phase II, III or IV); Phase I trials will not be reviewed;
• Brief description of key outcomes measures.
• A description of the patented medicine and its place in therapy, as supported by the clinical evidence, from the perspective of the Rights Holder.
• A description of the proposed comparators, including evidence of the same approved indication or use as the new patented drug product under review.
• A description of the comparable dosage regimens for the comparator(s) and the new patented drug product under review, including approved or proposed comparable doses or doses used in clinical trials or guidelines.
• Rights Holder’s proposals for level of comparability of each of the comparators along with the rationale or evidence supporting the proposal.

It is recommended that content of the Proposal be based on:

• Individual Trials/Studies evaluating the medicine under review:
• High quality published randomized clinical trials (RCTs) of the new patented medicine under review versus active comparators, if any; published RCTs of the new patented medicine under review versus placebo; high quality unpublished RCTs, if available.
• Published clinical trials with lower levels of evidence (e.g., outcome studies, systematic reviews of cohort and case-controlled trials) if high quality evidence is unavailable.
  Note: In relation to both higher and lower quality evidence, the Rights Holder is encouraged to focus the submission on key trials that lead to an NOC or to a change in clinical practice or would be of the highest quality/best evidence the Rights Holder has available. 
• Editorials and errata of published clinical trials.
• Publications discussing standards of therapy or accepted clinical practice for which the new patented drug product under review is indicated or used:
• For example, class reviews, systematic reviews/meta-analyses.
• Published Clinical Practice Guidelines regarding the indication or use of the new patented medicine under review if available:
• Peer reviewed Canadian guidelines are preferred; American, UK, Australian and European guidelines will be considered.

Rights Holders are encouraged to provide concise submissions focused on relevant information only.

Pricing information is NOT to be included in scientific submission, and all price-related information in supporting references is to be redacted.  If such information is included, the entire submission will be returned to the Rights Holder. 

The Rights Holder must include the name of the primary point of contact in communication with Staff during the scientific review process.  Submissions will be accepted from other sources, including consultants or third parties, however subsequent communications regarding the scientific review process will only take place between PMRPB Staff and the Rights Holder contact.

Requirements for filing electronic submissions

All Rights Holder submissions must be filed electronically. If a Rights Holder wishes to make a submission, these documents can be filed via our Online Filing Tool under “Scientific Submissions”.  Notification of an online file submission should be sent by email to PMPRB.Filing-Depot.CEPMB@pmprb-cepmb.gc.ca .  Requirements for filing electronic submissions are outlined below:

• All documents must be provided in a combined 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] Rights Holder Submission – Indication (if making multiple submissions for multiple indications) - Submission Date (e.g. Goodmed RH Submission – COPD – Sept 15 2025);
• 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 Rights Holder – See above for details on the suggested content of the proposal. Do not include any price justification or pricing details; if this information is included, the submission will be returned to the Rights Holder.
  C. References – please do not provide duplicate references or references that are not included in the submission. The references may be listed at the end of the document using a standard bibliographic citation style (e.g. American Medical Association, National Library of Medicine, American Psychological Association, etc.) and numbered corresponding with numerical references in the text. 
  
  For the naming of articles/references used within the PDF bookmarks, please minimize the characters used.  For example-
  1. Smith 2014
  2. (Company Name) Study
      a. Clinical Trial
      b. Relevant Findings