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.
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.
Please access the information by clicking on the links above.
Should you have any questions regarding the aforementioned information, please contact us at firstname.lastname@example.org.