New drug applications to Health Canada cancelled and refused: Cross-sectional study

Objectives This study looks at the number of cancellations by companies and refusals by Health Canada of new drug applications from 1 June 2019 to 1 July 2025 and the amount of information given for the decisions taken. Design Cross-sectional. Setting Canada. Participants New drug applications. Main outcome measures Number of applications cancelled or refused and reasons for decisions. Results There were 270 regulatory decisions of which 33 (12.2%) were either cancelled by the company (30) or refused by Health Canada (3). In 10 of the 30 cases where the submission was cancelled, there was no information about the reason for the company's decision. In the remaining 20 cases, the website just said that a decision had been made by the company. Two of the three refusals by Health Canada were because of concerns about safety and efficacy and quality-related issues. The third refusal was due to deficiencies and/or significant omissions in the clinical and non-clinical information. In the 30 submissions cancelled by the company, there was no information about what Health Canada thought in 6 cases. In 16 cases, Health Canada had not completed its evaluation, and in the remaining 8, the evaluation was completed. Conclusion Over 12% of new drug submissions to Health Canada are either cancelled or refused. Health Canada does not always fully communicate the information that it has regarding the reasons for these decisions and needs to be much more transparent about its decision-making.