In this case, the Hearings Judge dismissed Hospira’s application for judicial review of the Minister of Health’s decision to reject a New Drug Submission (NDS) without prejudice to the ability to refile. Hospira appealed, and the Court of Appeal allowed the appeal.
The Minister’s decision to reject the NDS was based on the fact that it did not contain pre-clinical and clinical data. The record before the Court contains uncontradicted evidence that no such clinical trials could be done ethically. The Court of Appeal held that the Minister has discretion as to the nature and form of the information that will be accepted as meeting the requirements of the Food and Drug Regulations for determining safety and efficacy. Thus, the Food and Drug Regulations did not require the Minister to reject the NDS at the screening stage. The Minister’s decision was quashed and the NDS was referred back to the Minister for reconsideration in light of these reasons.