On November 13, 2017, Québec’s Institut national d’excellence en santé et en services sociaux (INESSS) released a Notice to Manufacturers announcing further details on the continuous evaluation process.
As of December 1, 2017, manufacturers can submit an application for registration to INESSS for a new innovative drug product or a new indication of an already registered drug product that is pending a Health Canada Notice of Compliance only if the following criteria is satisfied:
- A Health Canada Notice of Compliance is expected within the next 180 days for an anti-cancer drug product or 90 days for any other drug product.
Please Note: The criteria for submitting pre-Notice of Compliance submissions has been revised since June 2017 and the above is the only criteria applicable as of December 1, 2017.
Although, INESSS will begin the scientific evaluation of the application if deemed admissible, INESSS will require the manufacturer to submit the Health Canada Notice of Compliance and Product Monograph before sending the final recommendation to the Minister of Health and Social Services. Please note that the conditions communicated in the Notice to Manufacturers on August 18, 2017 will only apply until November 30, 2017.
In addition, INESSS has also updated their forms, letter templates, checklists and submission guidelines. New versions of these documents are now available on the INESSS website. English versions will follow shortly. Effective immediately, manufacturers are to submit these new documents/requirements. With regards to the changes made to INESSS’ submission guidelines, the following additions are particularly noteworthy:
- Published Clinical Studies or Studies Submitted for Publication: Manufacturers must provide (in an electronic version) the Clinical Study Report (CSR) of the main clinical studies and, where a clinical study submitted for publication is filed in the application, manufacturers must forward the official publication as soon as available.
- Pharmacoeconomic Evaluation: It is expected that the preferred comparator used in the pharmacoeconomic evaluation is the one intended to be replaced or displaced by the evaluated drug. This comparator must be a medication on the Liste des médicaments, constitute a standard of care anchored in clinical practice in Quebec or be postponed by the Minister at the time of filing the application.
Effective immediately, the Drug Notification Form (DNF) and Letter Confirming Ability to Supply are no longer required by INESSS. These documents are only required for multi-source drug product applications. Manufacturers will be required to have supply as soon as the drug product is listed on the formulary.