Health Canada is consulting on proposed Agile regulations and guidance for licensing drugs and medical devices. It is proposing new targeted provisions and regulatory amendments to the Food and Drug Regulations and Medical Devices Regulations. These changes will continue to advance its modernisation agenda. The amendments will also:
- reduce regulatory issues and roadblocks to innovation
- make Canada’s science-based regulatory system more agile and internationally aligned
The proposal also takes into account recent experience with regulatory agilities successfully piloted as part of Health Canada’s response to the COVID-19 pandemic.
This regulatory initiative is part of Health Canada’s regulatory innovation agenda and will contribute to the government’s biomanufacturing and life sciences strategy.
What is the reasoning behind this consultation?
The pace of innovation today means that drugs and medical devices are evolving more rapidly than the traditional regulatory frameworks that were designed to regulate them. In addition, there has been a shift among international regulators towards greater post-market oversight with respect to drugs and medical devices.
Over time, Health Canada has been introducing legislative and regulatory amendments as well as implementing certain practices through policy to address these issues. Further regulatory amendments are required to provide a legal framework to support policy practices and to ensure transparency, predictability, consistency and compliance.
- Many of the regulations specific to biologic drugs (biologics) are overly prescriptive, product-specific and do not reflect current science and technology. The prospect of removing product-specific requirements for biologics highlighted the need to clarify the existing quality control rules and expectations under good manufacturing practices (GMP) requirements that apply to all products.
- Diverse subpopulations, such as women, racial minorities, children and the elderly, are often underrepresented in clinical trial data, impacting Health Canada’s ability to identify risk and the different safety and effectiveness profiles within diverse subpopulations.
- Lastly, the current requirements do not allow manufacturers to qualify limits for purity and potency that are different from those in publications listed under Schedule B of the Food and Drugs Act (the Act) that could be considered acceptable by Health Canada when a manufacturer’s standard is claimed. Furthermore, manufacturers of certain drugs are required to indicate the standard on the label of their drug, which is a Canadian-specific requirement and at times has created challenges for manufacturers due to limited space available on the label
Who is the focus of the consultation?
Health Canada is seeking comments from:
- academics
- consumer and patient safety organizations
- drug and medical devices industry
- health system partners
- the general public
What is feedback being sought on?
Feedback is sought on both, the proposed regulations and on multiple guidance documents and notices (either new or updated) on human and veterinary drugs and medical devices, related to the proposal.
Health Canada is seeking your ideas and input on the following key items/topics:
- using terms and conditions on drug approvals and broadening their scope for Class II, III and IV medical devices
- allowing rolling reviews of certain drug submissions, including drugs that address a public health emergency
- requiring risk management plans for higher-risk human drugs
- updating the requirements for certain drugs that claim a manufacturer’s standard
- repealing requirements for labelling of the standard for specific drugs
- repealing outdated requirements and replacing them with those that reflect current practices
- clarifying the authority to consider information obtained outside of a new drug submission to support Health Canada’s examination of that submission for a new drug
- requiring manufacturers to submit disaggregated data for new and supplemental human drug submissions
What are the expectations of the consultation?
It is expected that proposal of this consultation which is comprised of distinct components would:
- Enable the use of terms and conditions (T&Cs) on the drug identification number of any drug;
- Broaden the scope of use of T&Cs for Class II, III, and IV medical devices;
- Require risk management plans (RMPs) for certain human drugs to manage risks and uncertainties;
- Allow for rolling reviews of certain drug submissions, including those for drugs intended to address a public health emergency;
- Clarify expectations that a drug be fabricated, packaged/labelled, tested and stored, including during transportation, in a manner that assures its quality;
- Modernize requirements for biologics by repealing outdated requirements and replacing them with those that reflect current practices;
- Clarify, in regulation, the authority to consider certain information obtained outside of a new drug submission to support Health Canada’s examination of that submission for a new drug;
- Require manufacturers to submit human clinical trial data broken down by population subgroups (disaggregated data) for new and supplemental human drug submissions, as submitted to the United States Food and Drug Administration (USFDA) or the European Medicines Agency (EMA); and
- Update requirements respecting standards for labelling and requirements for those that claim a manufacturer’s standard for their drug.
How can you respond to the consultation?
You can respond to the consultation in two parts.
- To provide feedback on the proposed regulations, submit your comments through Canada Gazette, Part I.
- To submit comments on the multiple guidance documents and notices listed on this page and related to this proposal, use this online stakeholder feedback form (also available in MS Word format)
What are the consultation start and end dates?
Consultation start date: 17 December 2022
Consultation end date: 27 March 2023
Source: Health Canada