On February 13, 2018, the Canadian Agency for Drugs and Technologies in Health (CADTH) released a new CDR Update (Issue 133).
- Revisions to CADTH’s Biosimilar Review Process In August 2017, CADTH issued a consultation to seek input on how biosimilar reviews could be enhanced in Canada. Based on the feedback received, CADTH is making revisions to its process to reduce duplication of work, optimize resources, and facilitate decision-making for biosimilars for all participating jurisdictions. CADTH believes that a streamlined approach for biosimilar reviews will support improved access for patients. This process is effective February 13, 2018. For more detail about the requirements for making a biosimilar submission, please see the CADTH Common Drug Review Procedure and Submission Guidelines for Biosimilars for non-cancer indications and the CADTH pan-Canadian Oncology Drug Review Submission Guidelines for Biosimilars for cancer indications.
- Application Fees now apply to all CDR Submissions and Resubmissions Effectively immediately, all submissions and resubmissions filed by manufacturers are subject to an application fee irrespective of the date that the NOC or NOC/c was issued by Health Canada.
- New Fee Guidance for Applications to CADTH’s Pharmaceutical Review Programs CADTH has implemented a new fee structure that applies to both the Common Drug Review (CDR) and pan-Canadian Oncology Drug Review (pCODR) programs. The new Guidelines on Application Fees for CADTH Pharmaceutical Reviews replace the separate application fee guidelines which previously existed for each program. Other important highlights include:
- The new, reduced fee for the new biosimilar review process
- An annual fee adjustment based on fluctuations in the Consumer Price Index
- New Patient Input Templates CADTH has updated the instructions and templates for patient input. Patient groups contributing to a biosimilar review should use the following template Biosimilar Patient Input Template. The Standard Patient Input Template no longer includes prompts related to biosimilars.
- Revised Pre-submission Information Requirements Form Effective immediately, the CDR Advance Notification Form replaces the Pre-submission Information Requirements Form for all CDR submissions and resubmissions. The forms for submissions and resubmissions have been consolidated and the amount of information requested in the template has been reduced to ease the administrative burden of completing and updating the form. To provide advance notification of an upcoming CDR submission or resubmission, applicants are required to complete the updated form in its entirety and submit it to firstname.lastname@example.org. This change has been reflected in an updated advance notification procedure for pending CDR submissions and resubmissions.
- Revised Application Overview Template CADTH has updated the CADTH Common Drug Review Application Overview template. Manufacturers are required to use this updated template for all submissions and resubmission filed on or after March 1, 2018.
- Reminder: Clarifaxes/Clarimails for Pre-NOC Submissions Manufacturers who file CDR submissions on a pre-NOC basis are reminded that they are required to provide CADTH with revised Clarifax/Clarimail summary tables to reflect any additional Clarifaxes/Clarimails on an ongoing basis up to the point of the NOC or NOC/c being issued.
- Updated Contact Information for CDR-Participating Drug Plans The contact information for CDR-participating drug plans has been updated. To make this document easier to access, it will now be posted as a separate document on the CADTH website.
For more information, please refer to the CADTH website.