On November 7, 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.
INESSS would like to inform manufacturers that as of November 1, 2017, new terms and conditions apply for manufacturers who wish to request a pre-submission or a post-submission meeting with professionals from the Direction du médicament. Information regarding these new terms and conditions is available on the INESSS website, under the Rendez-vous des fabricants section.
Furthermore, as of November 28, 2017, INESSS will invite citizens, patients, caregivers and health professionals, as well as their associations and groups, to take part in a consultation related to drug products subject to a scientific evaluation for registration, under the new schedule. This consultation will be initiated four weeks before the manufacturer’s targeted date of filing the submission application for evaluation. It will be for a total duration of seven weeks.