Procedures for scheduling assessment requests
Two overriding criteria are considered for scheduling assessment requests from manufacturers which are submitted in accordance with the requirements of Form 1, Form 2, Form 13, Form A, Form PSS.
- Request prioritized by Health Canada, including ORBIS projects
Applications undergoing priority assessment by Health Canada (e.g. ORBIS project) are prioritized
- Aligned application between Health Canada - CDA-AMC - INESSS
Applications that undergo a harmonized review by Health Canada, CDA-AMC and INESSS are prioritized.
Other scientific evaluation requests are initiated progressively according to the schedule, over a maximum period of 180 days following activation of the evaluation.
For other evaluation objects, work will be initiated according to the following principles:
- Biosimilar drugs, filed according to the requirements of a Form 5 or Form 12, are evaluated on a first-come, first-served basis, over a maximum period of 90 days following activation of the evaluation.
- Evaluation objects, filed according to the requirements of Form 3, Form 4, Form 7, Form 8, Form 9, Form 10, Form 11, Form B and Form C, are evaluated on a first-come, first-served basis, over a maximum period of 120 days following activation of the evaluation.
- Multisource drugs (generic or natural health product), filed according to the requirements of a Form 6, are analyzed in batches, according to drug list updates.