Expanding CADTH’s Drug Review Processes to include Radiopharmaceutical Submissions and Other Process Alignment Implementations

1. Expanding CADTH’s Drug Review Processes to Include Radiopharmaceuticals

In collaboration with the participating jurisdictions, CADTH is pleased to announce that CADTH will accept submissions for radiopharmaceuticals used for therapeutic purposes (i.e., not for diagnostic purposes) for review through the CADTH Common Drug Review (CDR) and the CADTH pan-Canadian Oncology Drug Review (pCODR) programs effective April 1, 2017.

Applicants/Submitters planning to file a submission or resubmission for a radiopharmaceutical on or after April 1, 2017 to CDR or pCODR must comply with the same procedures, submission requirements, and timelines for a drug as set out by the CDR and pCODR programs. Consistent with the input and feedback processes for CADTH’s respective drug review programs, stakeholders (e.g., patient groups and registered clinician[s]) will have an opportunity to provide input and feedback on a radiopharmaceutical submission.

For more information on a planned submission to the CDR program, please see: https://www.cadth.ca/about-cadth/what-we-do/products-services/cdr/common-drug-review-submissions.

For more information on a planned submission to the pCODR program, please see: https://www.cadth.ca/pcodr/submit-a-drug.

2. Implementing Request for Advice and Biosimilar Review Processes for CADTH’s pan-Canadian Oncology Drug Review Program

As part of the ongoing process to align and to build on best practices for CADTH’s two drug programs, CDR and pCODR, to create more transparent and predictable drug review processes for all stakeholders, CADTH is implementing a process for: 1) a request for advice; and 2) biosimilar reviews submitted to the pan-Canadian Oncology Drug Review (pCODR) program.

  1. Implementing Request for Advice Process for pCODR
  2. Implementing a Biosimilar Review Process for pCODR

Please access the information by clicking on the links above.

These new requirements will be incorporated into the pCODR Procedures and pCODR Submission Guidelines, and will come into effect as of April 1, 2017.

Should you have any questions regarding the aforementioned information, please contact us at requests@cadth.ca.