Lessons from Canada's notice of compliance with conditions policy for the life-cycle regulation of drugs.

ABSTRACT: Innovative health technologies are not well regulated under current pathways, leading regulators to adopt contextual, life-cycle regulatory models, which authorize drugs based on earlier clinical evidence subject to the conduct of post-market trials that confirm clinical benefit and safety. In this paper, we evaluate all drugs authorized in Canada under the Notice of Compliance with conditions (NOC/c) policy from 1998 to 2021 to analyze its function, identify challenges and areas for improvement, and make recommendations to inform Health Canada's regulatory reforms. We analyzed a sample of 148 drugs authorized between 1998 and 2021, including characteristics about the pre- and post-market clinical trials, finding that most NOC/c authorizations are based on one, single-arm clinical trial us

SUBMITTER: McPhail M 

PROVIDER: S-EPMC10101551 | biostudies-literature | 2023 Jan-Jun

REPOSITORIES: biostudies-literature