Since launching a pilot project to expand clinician participation in the pan-Canadian Oncology Drug Review (pCODR) process in February 2016, the Canadian Agency for Drugs and Technologies in Health (CADTH) has received input from clinicians, the pCODR Expert Review Committee and the Provincial Advisory Group on ways to enhance the process.
In light of this input, CADTH is proposing the following key changes:
- A new template for clinician input, with customized questions specific to the drug and indication under review
- Expanding eligibility criteria to include oncology pharmacists and oncology nurses
CADTH is inviting stakeholder feedback on the proposed revisions until April 20, 2018 at 5:00 p.m. ET. For more information including how to submit feedback, please refer to the CADTH announcement.
INESSS moving to continuous review process for Stable Blood Products
Effective November 16, 2018, the Institut national d’excellence en santé et en services sociaux (INESSS) will revise its Stable Blood Products evaluation process and submission requirements. The key changes include:
- Move to a continuous evaluation review cycle (replacing 2 submission deadlines per year)
- Manufacturers to submit 2-month mandatory advance notice of submission
- Patients and health professionals will be able to provide input to reviews
- Manufacturers will be able to request a post-submission meeting
- A new submission checklist has been created to be used for submissions made after November 15, 2018. New requirements include product labels, method for pathogen inactivation and Health Canada Reviewers’ Report
An information session for manufacturers will be held on April 11, 2018 at 9:00 am in Québec. For more information, please visit the INESSS website.