Departmental Actions to respond to the Red Tape Reduction Commission's Recommendations Report
The Red Tape Reduction Action Plan sets out the Government of Canada's common-sense approach to cutting red tape so entrepreneurs can focus on doing business and creating jobs. The Action Plan introduces fundamental, system-wide reforms and department-specific changes. These will address a broad range of irritants to businesses, as well as the systemic barriers that unnecessarily frustrate and burden Canadian business with additional delays, costs and bureaucracy.
List of Announceables
- To improve accountability and services related to the review of human drug and medical device submissions, and to respond to requests in a timely manner, we recommend that Health Canada update processes, as necessary, and meet established review performance standards.
- To improve predictability in the application of regulations and policies for food and to improve the opportunity for businesses to input into their design and application we recommend that Health Canada: Address areas that exist in the current regulatory frameworks, including food fortification, food additive and novel food frameworks, to ensure that they support rapid response to emerging food safety issues or opportunities for innovation and growth;
- Development of a regulatory approach for "orphan drugs" (to treat rare diseases), leveraging work with the United States and other international regulatory counterparts;
- To remove unnecessary barriers and burden while continuing to ensure the highest level of safety for Canadians we recommend that Health Canada modernize its regulatory framework, with a move to more proportional oversight based on risk, through: The development of a more flexible and risk-based regulatory framework for food additives.
- To alleviate the financial burden that revised user fees may have on applicants, we recommend that Health Canada address pharmaceutical, biotechnology and radiopharmaceutical small business realities by providing opportunities for the remission of fees for qualifying companies (with the effect of reducing the amounts paid in relation to products that have low volumes of sales).
- To reduce administrative burden and improve service related to the review of changes to approved drugs, we recommend that Health Canada streamline its post-approval changes system and eliminate the category for minor chemistry and manufacturing changes to pharmaceuticals.
- Complete the review by February 2013 of applications received before August 2010, which are subject to the Natural Health Products (Unprocessed Product Licence Applications) Regulations;
- Improve screening and review processes.
- To reduce the administrative burden faced by applicants and regulators for the registration and amendment of registered pest control products in Canada, we recommend that Health Canada continue to review its current notification/non-notification policy with a view to reduce approval times and regulatory requirements for certain administrative and scientific changes to registered pesticides.
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