BIOTECanada provided feedback to Health Canada on a Draft Guidance on the Ministerial Reliance Order concerning decisions or documents on certain drugs by foreign regulatory authorities as part of Canada Gazette, Part II. BIOTECanada is committed to supporting Health Canada throughout the regulatory development process, including engagement in the Ministerial Reliance Order. The Reliance mechanism represents an important forward thinking and modernized regulatory approach, with significant potential to reduce red tape:
- To allow Health Canada to refocus resources to address the increasing volume and complexity of drug submissions, allowing critical expertise to be directed to higher-risk and complex work;
- Encourage manufacturers to bring drugs to Canada, and file submissions earlier; and
- Reduce red tape, reduce regulatory duplication and support accelerated access to needed treatments.
BIOTECanada acknowledges Health Canada’s recognition that Reliance should balance regulatory efficiency with maintaining Health Canada oversight and robust standards and recommend
- Expand usage of Reliance
- Expand and accelerate Reliance for innovative drugs, particularly those in high impact therapeutic areas
- Rapid implementation of Reliance with metrics
- Commit to an implementation timeline, with a shortened submission review timeline
- Establish publicly available performance indicators and regular reporting to measure uptake and timeliness.
- Establish an industry advisory group