On April 4, 2018, Québec’s Institut national d’excellence en santé et en services sociaux (INESSS) released a notice to manufacturers announcing further details on the evaluation process.
Manufacturers can submit an application for registration to INESSS for a new innovative drug product, a new biosimilar drug product, a new product that is analogous to a complex non-biologic 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.
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.
Evaluation Process for Biosimilars
INESSS subscribes to the accessibility of biosimilar drug products in Québec. In compliance with the Act respecting INESSS, it is implementing a new simplified biosimilar drug evaluation process that will allow work to begin before the Health Canada Notice of Compliance is received, reduce the evaluation time required and generate savings as a result of their listing on the drug lists.
INESSS would like to inform you that the various forms, checklists and letter templates offered to support manufacturers in the preparation of their applications have been updated accordingly. These new versions are available on the INESSS website. The English version of these documents will follow as will the update of the document titled “Guide de soumission d’une demande à l’INESSS”.