Health and Biosciences: Targeted Regulatory Review – Regulatory Roadmap
Published: June 2019
Last update: January 2021
The Health and Biosciences Sector Regulatory Review Roadmap outlines Health Canada's plan to address the issues, irritants, and bottlenecks identified by stakeholders that affect innovation and economic growth in the health and biosciences sector. This roadmap is a result of the Targeted Regulatory Reviews, and is organized in the following sections:
- Health Canada's Approach for Regulatory Review
- Consultation Undertaken
- Ongoing Regulatory Modernization Activities
- Issues and Irritants
- Novel Approaches
- Sector Issues and Irritants not being addressed by Health Canada
Details and anticipated timelines for the initiatives identified in this roadmap can be found in Health Canada's Forward Regulatory Plan.
See Health Canada's Program and Policy Initiatives and Novel Regulatory Approaches for details on the policy, program and novel approaches identified in this roadmap.
Protecting the health and safety of Canadians is Health Canada's first priority. However, it is also important that regulatory frameworks support the adoption of promising new therapies in the health-care system and do not stifle innovation that could improve the health of Canadians.
The pace of innovation today means products are evolving and moving to market more rapidly than traditional regulatory frameworks are designed to accommodate. New technologies are resulting in widespread innovations in diagnostic tools, disease prevention and drug discovery. New products and therapies are challenging the foundations of a regime built around traditional models of sale, manufacturing, pre-market approval, clinical trial evidence and labelling, among other things. A new approach is required to enable access to advanced treatments, and to make products safer through stronger post-market controls.
The initiatives in this roadmap aim to address issues raised across a variety of products, from cosmetics, natural health products, non-prescription drugs, and workplace chemicals to products that challenge traditional categories, such as software and 3D printers.
The health and biosciences sector and Canadians
Health Canada is the federal department responsible for helping Canadians maintain and improve their health, while respecting individual choices and circumstances.
Every day, Canadians rely on a wide variety of health products to address their needs, ranging from maintaining healthy teeth to dealing with critical, life-threatening illnesses. Health products include prescription drugs, biologics (such as vaccines and tissues), self-care products (such as toothpaste, shampoo, vitamins, pain relievers, lip balm), radiopharmaceuticals and medical devices. They also rely on the safety of consumer products, as well as information about the safe use of workplace chemicals, to prevent illness and injury that can result from poorly made or non-compliant items.
The health and biosciences sector encompasses a wide range of companies, from the developers and manufacturers of drugs, medical devices and biomedical innovations, to producers of digital health solutions and disruptive technologies such as artificial intelligence, big data analytics, 3D printing, robotics and nanotechnologies. Also included are importers, distributors, and manufacturers of workplace chemicals and of products ranging from childrens' toys to holiday lights.
New trends such as advanced cell and gene therapies, and 3D printing of implants will radically personalize health care, and carry with them impressive economic potential. These advancements will provide Canadians with access to beneficial new and innovative therapies upon which they depend for their health and quality of life.
The majority of the Health Portfolio'sFootnote 1 regulatory frameworks were designed at a time when most products on the Canadian market were manufactured in Canada. Today, most regulated products are imported into Canada and many come from countries that have different regulatory frameworks in place.
The arrival of new products, such as medical devices created with 3D printers, and non-traditional means of accessing these products (e.g., selling and advertising online) challenge existing oversight mechanisms and scientific approaches. Additionally, as advanced technologies allow health products to be increasingly tailored and customized to individuals (e.g., such as advanced cell and gene therapies, and 3D printing) the production of large scale, population level pre-market evidence will become less possible or relevant. Such technology tests the idea of "sale" and "manufacture" in the Food and Drugs Act and the very concept of 'products' in product regulation. These evolutions in manufacturing and markets create uncertainty about how to identify and manage quality and safety issues through modern regulatory frameworks and approaches.
Health Canada must evolve and adapt to this new environment:
- Where products used to fall into distinct siloes (cosmetics, non-prescription drugs, natural health products), there are now increasingly overlapping product categories. For example, toothpaste can be a cosmetic if it is marketed as whitening teeth; a non-prescription drug if it claims to prevent gingivitis; or a natural health product if it contains certain ingredients from natural sources. A more integrated approach is needed to provide appropriate oversight and controls.
- Where manufacturing used to be conducted domestically such that "made in Canada" solutions were appropriate, Health Canada now operates in a global market with high volumes of imported products (e.g., 80 per cent of drugs used by Canadians are imported from foreign sites). This makes international regulatory cooperation and partnership an imperative.
- The health and biosciences environment used to be highly predictable, with small numbers of regulated parties, facilitating a cyclical approach to regulation and enforcement. Now, there are many new players making it more challenging to manage potential health risks in the market. This requires a greater focus on areas of highest risk (e.g. a risk-based approach).
- In today's environment, rapid innovation and new technologies are leading to the development of products for the market more quickly. This means Health Canada needs more agile and dynamic systems to make informed regulatory decisions in real time.
Canadians trust that the products they use are safe, effective, and subject to appropriate oversight. At the same time, they expect these safeguards will not limit their access to new and innovative products and therapies.
The health and safety of Canadians is Health Canada's first priority and bringing regulatory frameworks, systems, and practices up to date is imperative to be an effective regulator.
Health Canada's Approach to the Regulatory Review
In order to capitalise on the opportunity to review regulatory frameworks in the health and biosciences sector, Health Canada focussed its review on the following frameworks:
- Canada Consumer Product Safety Act and its regulations
- Controlled Drugs and Substances Act and its regulations
- Food and Drugs Act and its
- Food and Drug Regulations (as they relate to drugs only)
- Medical Devices Regulations
- Natural Health Products Regulations
- Hazardous Materials Information Review Act and its regulations
A number of regulatory frameworks, for example cannabis, tobacco and vaping, pricing of patented medicines, monitoring of medical assistance in dying, assisted human reproduction, and cost recovery have undergone very recent modernization, or are in the process of being modernized and were not included in the scope of the review. Many of these frameworks have built-in review timelines and additional time is required to determine whether recently developed or implemented approaches will be effective before further adjustments are considered. In addition, a number of areas of Health Canada's responsibility are scoped into the Agri-food and Aquaculture Sector Regulatory Review.
For more details, see Sector Issues and Irritants not being addressed by Health Canada.
The Regulatory Review process involved extensive stakeholder engagement, including the following:
- the Economic Strategy Tables;
- departmental consultations and bilateral discussions; and
- the Regulatory Review consultation in Canada Gazette, Part I.
Health Canada held a number of targeted consultations for the purpose of the Health and Biosciences Sector Regulatory Review throughout the summer of 2018 to discuss the initiative, answer questions, and gather feedback. These engagements were focused on industry members (e.g., major associations, small-to-medium enterprises and start-ups), but also included patient advocacy groups and professional associations, such as those representing researchers, clinicians, nurses or pharmacists. Interested parties were also encouraged to submit their comments to the formal Regulatory Review consultation in Canada Gazette, Part I, led by the Treasury Board of Canada Secretariat from July through September 2018. In addition, Health Canada sent a notice to its stakeholders (over 2,200 individuals or companies on its distribution list) to inform them of this opportunity to provide input via written feedback.
For a summary of the stakeholder engagement on the targeted Regulatory Reviews, see the What We Heard Report on Regulatory Reviews and modernization stakeholder consultations.
Health Canada also took into consideration information it had received through other avenues, including ongoing engagement with stakeholders, and regulatory cooperation fora. This included the:
- Canada-United States Regulatory Cooperation Council (RCC)
- Canadian Free Trade Agreement's Regulatory Reconciliation and Cooperation Table (RCT)
- Canada-European Union Comprehensive Economic and Trade Agreement's Regulatory Cooperation Forum (RCF).
The review also considered recent non-governmental reports, for example:
- Death by 130,000 Cuts: Improving Canada's Regulatory Competitiveness, published by the Canadian Chamber of Commerce in May 2018; and
- Recommendations coming from the Economic Strategy Tables, including those from the Health and Bio-sciences Table.
Health Canada heard from stakeholders on a wide range of issues over the course of the sectoral review process. Stakeholder input was carefully considered in order to offer a number of solutions that range from the very targeted, to more fundamental and broad-reaching changes. It is expected that industry stakeholders across numerous product lines will be able to identify positive change from this Roadmap.
Ongoing Regulatory Modernization Activities
The 2018 Regulatory Review took place as Health Canada was introducing regulatory and policy reforms that will contribute to the health and safety of Canadians, modernize operations and deliver on the Government's commitments. This also includes changes to core regulatory and enforcement programs to be more efficient and enable innovation. Various issues raised by stakeholders are being addressed through initiatives already completed or currently underway.
This section outlines a few key areas of work that align with the goals of the review, and address comments received from stakeholders.
Regulatory Review of Drugs and Devices
In 2017, Health Canada launched the Regulatory Review of Drugs and Devices (R2D2) initiative, with the goal of having a regulatory system that provides greater and faster access to therapeutic products that are better aligned with healthcare system needs.
Activities within this initiative are numerous, and many address issues identified by stakeholders during the sectoral review consultations. For example, stakeholders identified that the process to get drugs and medical devices from early development to Canadian patients takes years, and requires several steps after Health Canada regulatory approvals. Health Canada is taking a more agile approach by streamlining its regulatory processes and aligning with health technology assessments by CADTH and INESSSFootnote 2. This would enable the pharmaceutical industry to bring new drugs to Canada more quickly, benefiting patients, and potentially increasing revenues for patented drug makers.
Health Canada is also reviewing the regulations related to self-care products, which include natural health products, non-prescription drugs and cosmetics. Currently, three different sets of rules apply to self-care products, each with different requirements and oversight. Some of these rules – specifically, the regulations for non-prescription drugs – are over 50 years old. In comparison, newer regulations for natural health products were established in 2004.
Proposals within the Self-Care Framework include:
- more risk-based regulating
- providing consumers the information they need to make an informed choice
- measures to eliminate unnecessary duplicative requirements
- measures that will remove regulatory obstacles, reduce the overall cost of compliance, and support innovation in the cosmetic market
The framework also includes very important health and safety measures, such as improved labelling for natural health products, to align with the measures in place for non-prescription drugs on store shelves. The proposed changes to these lower-risk types of self-care products will support consumer choice, as well as safety, while applying a level of regulatory oversight that is proportionate to risk. This will enable Health Canada to provide increased scrutiny to higher-risk products, while reducing the regulatory burden applied to lower-risk products.
There are several smaller, regulatory modernization projects underway, for example:
- A broad, multi-year plan to modernize regulations under the Controlled Drugs and Substances Act. Work is underway to publish proposed and final amendments to the Narcotic Control Regulations, the Benzodiazepines and Other Targeted Substances Regulations, and parts of the Food and Drug Regulations.
- A new regulatory framework for health products that are exported or shipped in transit through Canada. This will facilitate alignment with international commitments under the World Trade Organization Trade Facilitation Agreement (WTO-TFA) and the Canada-European Union Comprehensive Economic and Trade Agreement (CETA).
International alignment and harmonization
Stakeholders expressed the need for Health Canada to continue its efforts to harmonize and align international requirements. Health Canada is a participant in a large number of international fora that work towards harmonizing requirements, such as the:
- International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use
- North America Cooperative Engagement Framework on Consumer Product Safety
- Global List Informal Correspondence Group (ICG) of the United Nations Sub-Committee of Experts on the Globally Harmonized System of Classification and Labelling.
In addition, Health Canada has created a number of working groups with like-minded nations, such as the European Medicines Agency and the U.S. Consumer Product Safety Commission, to focus on issues of mutual concern. Health Canada has also established a number of mutual recognition agreements, memoranda of understanding, and confidentiality arrangements to enable the sharing of information with other regulators, which results in increased alignment of approaches for compliance and enforcement. Health Canada continues to pursue new agreements and arrangements, where possible.
Lastly, Health Canada has undertaken initiatives that make greater use of analyses completed by other regulatory agencies, such as considering assessments, test results or inspections, conducting joint or coordinated reviews, and accepting certain decisions made by trusted regulatory partners.
All of these efforts have resulted in various processes, requirements, and regulations that are better aligned with international partners. For example, Canada's Precursor Control Regulations and the U.S. Controlled Substances Act are aligned and designed to meet the requirements of the United Nations Convention Against Illicit Trafficking in Narcotic Drugs and Psychotropic Substances, which reduces burden on industry and also helps ensure that unauthorized shipments are stopped before the issuance of a permit. In addition, the good manufacturing practices requirements for drugs are written with a view to harmonize with standards from other countries and international organizations, such as the World Health Organization.
Health Canada will continue its efforts to increase international harmonization, while ensuring that decisions are made in accordance with Canadian requirements and standards to protect the health and safety of Canadians.
Government Policies on Regulation
Health Canada heard from a number of stakeholders that there is a need to improve the regulation-making process in order to be more agile and make better-informed decisions. This may include the following:
- earlier, sustained and transparent engagement with stakeholders throughout the entire regulatory life-cycle;
- periodic reviews of existing regulations;
- development of rigorous and evidence-based cost benefit analyses; and
- giving consideration to supporting economic growth and innovation.
The Cabinet Directive on Regulation, which came into force September 1, 2018, sets out the Government of Canada's expectations and requirements for the development, management, and review of federal regulations. The Directive incorporates the principles raised by stakeholders and Health Canada is committed to meeting its guidelines. Engaging with the public is an important part of Health Canada's work. Health Canada will continue to engage Canadians throughout the implementation of the roadmap through open communication and consultation exercises on the specific projects. The input obtained during these public engagements will guide our discussions and inform our decision-making on policy and program development, service delivery, and statutory and regulatory initiatives.
Issues and Irritants
Health Canada's regulations were developed when products were predominantly produced domestically, in simpler, vertically-integrated systems. Today's manufacturing environment has complex global supply chains, where the majority of products used by Canadians are imported, and the products themselves are emerging, and evolving at a rapid pace. Canada's current regulatory frameworks are not designed to accommodate the variety and complexity of products now seeking to enter the Canadian market.
- Made in Canada approach built around domestic production practices and markets
- Prescriptive, one-size fits all approaches to regulations that could not easily adjust to new products
- Siloed regulatory frameworks that sometimes resulted in different requirements for similar types of products and services
- Global collaboration in standard setting and work sharing to improve regulatory efficiency and enable innovation
- Use of novel and flexible approaches to regulate innovative therapies and practices
- Integrated, risk-based approach to regulating product categories and services
This new environment and future outlook require that Health Canada develop and prioritize the following:
- Integrated regulatory frameworks to improve consistency and predictability across product categories
- A global approach to improve efficiency and reduce regulatory burden by leveraging partnerships with international regulators.
- Adopting a more risk-based approach to reduce burden and effectively deploy resources.
- Creating more agile, flexible frameworks to better support innovation and manage emerging risks.
The sectoral regulatory review provided an opportunity to update legislation and regulations, review and revise regulatory processes, and explore new approaches that would modernize Health Canada's oversight.
Specific comments from individual stakeholders have been organized under the four principle themes identified above: Integration, Global Systems, Risk-based Approaches and Agile Frameworks.
Regulations that respond to increasingly overlapping product categories.
Currently, there are different requirements for similar types of products based on out-dated product risk profiles. By relying on guidance to make product categorization decisions, small changes in product profile (e.g., the addition of a low risk ingredient) can be more easily managed by regulatory decision makers.
Stakeholder comments related to this theme focused on two key issues:
Current medical device requirements are creating barriers for a changing industry
Health Canada regulates medical devices to ensure their safety and effectiveness when they are used to diagnose or treat patients in the Canadian healthcare system. However, stakeholders have identified a number of concerns about how current regulations can hinder innovation. For example, manufacturers of software medical devices frequently modify their products in response to real-world performance, and have expressed frustration about requirements to bring in frequent new submissions for minor product improvements or fixes.
Health Canada proposes to address the concerns raised by taking the following actions:
- Providing an exemption for certain low risk digital health software from regulatory requirements (e.g., software intended to monitor heart rate and daily calorie intake to allow an individual to self-manage their weight and fitness levels).
- Exploring the need to amend provisions relating to the sale of devices (e.g., different distribution methods for accessing medical device software).
- Exploring an alternative to certify manufacturers of innovative software as a medical device through a novel regulatory approach.
Further, to continue building on the strong foundation of Canada's existing regulatory approach to medical devices, a Medical Devices Action Plan was recently launched. It lays out a three-part strategy, which will be achieved through improving how devices enter the market; strengthening monitoring and follow-up of devices once they are being used by Canadians; and providing more information to Canadians about the medical devices they use. The Action Plan will help industry by providing predictability about future changes and by increasing transparency around the department's proposed plan. In addition, the plan aims to increase consumer confidence in the medical devices they use through the focus on ongoing market monitoring and through information sharing.
These adjustments will respond to stakeholder calls for an updated approach that will be agile enough to keep pace with new technologies. They will also support digital health care innovation in Canada, while ensuring proper oversight to safeguard Canadians and optimize patient safety and benefits. Further, they will provide clarity to industry that is currently lacking for products that fall outside of the traditional manufacturer-to-consumer model.
Addressing these concerns was identified as an early action in the 2018 Fall Economic Statement. Proposed legislative amendments are being sought as part of the Budget Implementation Act, 2019. If needed, Health Canada anticipates advancing proposed regulatory amendments in Canada Gazette, Part I in spring 2022 and final publication of the regulatory amendments in Canada Gazette, Part II in spring 2023. For further details, see:
- Health Canada's latest updates
Self-care products are subject to varying regulations
Health Canada is working to better align regulations across self-care products. Currently three different sets of regulations apply to certain self-care products based on the type of ingredients used as opposed to the risk they present. For example, a consumer looking to purchase sunscreen would find various options on the store shelf that look very similar. However, depending on the ingredients and the claims made, a sunscreen can be regulated as a natural health product, a non-prescription medication, or a cosmetic. This makes it difficult for consumers to make informed choices and creates an uneven playing field for industry, discouraging the development of new and innovative self-care products in Canada.
Health Canada proposes to amend the Food and Drug Regulations, Natural Health Products Regulations and the Cosmetics Regulations to introduce a more risk-based approach for self-care products. Health Canada intends to introduce agile, responsive and appropriate processes for the registration of low-risk products (such as toothpaste, sunscreens and cough drops being able to access the market through an automatically validated system), and a licence application with pre-market review for higher-risk products (such as recent prescription drug switches or non-steroidal anti-inflammatories (NSAIDS) which will require clinical data and a label review).
The modernized self-care regulations would address the unnecessarily burdensome requirements to bring low-risk products to market, the one-size fits all approach to fees for those products, the delays to market for new low-risk products, and the duplicative requirements for products that have been proven to meet the testing requirements and quality standards in other trusted jurisdictions. Canadians would benefit from the changes by having improved access to new products and being better able to make informed choices. Canadians will be able to have confidence that the self-care products they use will be safe, effective and of high quality.
To make the necessary changes to implement this initiative, Health Canada anticipates advancing proposed amendments to the Food and Drug Regulations and the Natural Health Product Regulations in Canada Gazette, Part I in spring 2020. For further details, see:
Theme: Global Systems
A global marketplace increases the need to reduce barriers to trade and collaboration with international partners in setting standards and sharing work.
In the past, Canadian production supplied our market. The increasingly global nature of the sector requires that we align ourselves with international partners as appropriate.
Stakeholder comments related to this theme have been grouped into three issues, for which action will be taken.
Clinical trial record retention timelines are misaligned and burdensome
During consultations on the sectoral review, Health Canada heard that the current record retention period for clinical trials is overly burdensome and misaligned with other jurisdictions, creating a barrier to economic growth and innovation in Canada. To encourage clinical trials to be conducted in Canada and to increase Canadians' access to novel therapies, Health Canada is proposing to amend the Food and Drug Regulations to reduce the current record retention requirement from 25 years to a minimum of 15 years. This proposed amendment would improve alignment with other jurisdictions and reduce regulatory burden to better support the conduct of clinical trials in Canada without compromising the health and safety of Canadians.
This initiative was identified as an early action in the 2018 Fall Economic Statement. To make the necessary changes to implement this initiative, Health Canada anticipates advancing proposed amendments to the Food and Drug Regulations in Canada Gazette, Part I in spring 2020. Final publication of the regulatory amendments in Canada Gazette, Part II is anticipated in winter 2021. This will be the first step in a process of updating the approach to clinical trials more generally, as further described in the Modernization of the Regulation of Clinical Trials initiative. For further details, see:
- Health Canada's latest updates
Recall reporting expectations for drug and medical devices are unclear and are not all aligned with the U.S.
Recalls are actions taken by a company to remove a product from the market that may present a health and safety hazard. Health Canada relies on recalls to address and correct issues that present risks to consumers. Stakeholders have raised that the timelines and expectations they have to meet for reporting recalls on drugs and medical devices are unclear, and in the case of medical devices, are misaligned with requirements in the United States. This creates administrative burden on industry.
Health Canada proposes to amend both the Food and Drug Regulations and the Medical Devices Regulations to update existing recall requirements to:
- establish clear responsibilities for industry on the conduct of a recall; and
- align recall reporting requirements with those in the US.
It is proposed that the overly broad definition of the term "recall" in the Medical Device Regulations be repealed in order to address the current requirement to notify Health Canada of actions which do not involve removing a device from the market. In parallel, a risk-based threshold for reporting recalls of medical devices being removed from the market will be developed.
These proposed amendments are intended to improve the effectiveness of recalls in Canada and to strengthen recall requirements to minimize the exposure of Canadians to defective or unsafe drugs and medical devices. It would improve the predictability and efficiency of recalls for industry without negatively impacting the health and safety of Canadians.
To make the necessary changes to implement this initiative, Health Canada anticipates advancing proposed amendments to the Food and Drug Regulations and the Medical Device Regulations in Canada Gazette, Part I in winter 2020. Final publication of the regulatory amendments in Canada Gazette, Part II is anticipated in winter 2021. For further details, see:
- Health Canada's latest updates
Consumer product requirements are not always aligned with international partners and rely too heavily on regulatory approaches
The consumer product industry has expressed a clear preference for relying more heavily on standards, particularly those which strengthen further alignment with major trading partners, for the protection of consumers from the potential hazards of consumer products.
Health Canada is proposing to develop an Instrument of Choice Framework that would set out the considerations and the process for how it determines which regulatory tool or instrument will be used to address a consumer product safety hazard and protect Canadians, such as guidance materials, voluntary standards, or regulations. More specifically, the Framework will establish clear terms for how the Consumer Product Safety Program identifies and considers appropriate standards that will facilitate increased use of the general prohibitions. This framework would comply with the Cabinet Directive on Regulation.
Industry will benefit from a clear articulation of instrument choice decisions, more timely guidance on how to address emerging risks, and reduced regulatory barriers through increased international alignment with trusted regulatory partners.
Health Canada expects to consult stakeholders on the modernized Instrument of Choice Framework by fall 2019 to facilitate implementation of this initiative. For further details, see:
- Health Canada's latest updates
Theme: Risk-based Approaches
Shifting from one-size-fits-all approaches to applying a level of regulatory oversight that is flexible and proportionate to risk.
Slow regulatory responses to rapidly changing markets have meant that evolving product types have been force-fit into regulatory regimes that were not designed with such evolution in mind. This type of one-size-fits-all approach has proven especially inappropriate for low-risk products that have been subject to requirements better applied to products presenting higher risk. A wider range of modern regulatory tools is needed to adapt to changes more quickly. These tools could include using incorporation by reference to enable updates to requirements, which may change based on new science or product innovation.
Stakeholder comments related to this theme have been grouped into three issues, for which action will be taken.
Clinical trial regulations are limiting growth
Clinical Trials are an important step in the development of new therapies entering the Canadian health care system and marketplace. They play a key role in the access to drugs and devices for Canadians.
Stakeholders have raised concerns that current regulations for clinical trials are reducing Canada's competitiveness in attracting clinical trials, and constraining the sector's growth in various ways across the business lines of prescription and non-prescription drugs, medical devices, natural health products, veterinary drugs and foods. For example, infant formula manufacturers are not permitted to conduct clinical trials in Canada to generate the evidence required to demonstrate the safety and nutritional adequacy of a new infant formula, and the requirements for medical device investigational trials are out of step with international counterparts.
Health Canada proposes to modernize the regulation of clinical trials across business lines in order to introduce a coherent and comparable risk-based approach and afford greater flexibility in the safe development of innovative therapies. Health Canada is also proposing to examine opportunities to streamline regulations across the lifecycle of clinical trial application and post-authorization processes toward a more simplified, predictable environment for regulated parties that would be more efficient and easier to use. These changes are expected to facilitate patient access to more potentially life-saving trials and new therapies, while providing greater public access to information on clinical trials.
Benefits of this proposal include the following:
- Reduced costs for industry and academics,
- Natural health product investigators will benefit from decreased approval timelines for their trials,
- Enabling investigational testing of medical devices by independent researchers and healthcare professionals (not only manufacturers), and
- Improving alignment with global partners and best practices.
This initiative was announced in Budget 2019. Proposed legislative amendments are being sought as part of the Budget Implementation Act, 2019. To make the necessary changes to implement this initiative, Health Canada anticipates advancing proposed amendments to the Food and Drug Regulations, the Medical Device Regulations and the Natural Health Products Regulations in Canada Gazette, Part I in fall 2021. Final publication of the regulatory amendments in Canada Gazette, Part II is anticipated in spring 2022. For further details, see:
- Health Canada's latest updates
Limitations on the distribution of drug samples are causing barriers to access for Canadians
The Food and Drugs Act prohibits the distribution of prescription drugs, non-prescription drugs (NPDs) and natural health products (NHPs) as samples to anyone other than a physician, dentist, veterinary surgeon or pharmacist under conditions set out in regulation; this prohibition restricts the distribution of NPDs and NHPs to the general public.
Health Canada proposes to address this by amending the Food and Drugs Act and its regulations to enable the distribution of certain authorized low risk non-prescription drugs and natural health products as samples, directly to consumers under certain conditions. In addition, the list of practitioners permitted to distribute drug samples would also be expanded to include those with prescribing authority under provincial and territorial law. Broader authorities would allow industry to better market their low-risk products to consumers and ultimately grow to be more competitive in the health product market. It will also enable public health associations and public health authorities to support public health initiatives (for example, the distribution of sunscreens at public outdoor events).
Health Canada intends to introduce legislation to make necessary changes to implement this initiative, at the earliest opportunity. To implement this initiative, Health Canada anticipates advancing proposed amendments to the Food and Drug Regulations and the Natural Health Products Regulations in Canada Gazette, Part I in fall 2021. Final publication of the regulatory amendments in Canada Gazette, Part II is anticipated in spring 2022. For further details, see:
- Health Canada's latest updates
Additional IT tools are needed to facilitate interaction with Health Canada
Health Canada's current system for required reporting by regulated parties under the Controlled Drugs and Substances Act (e.g. reporting of loss and theft of a controlled substance, sales, and inventory data) is extremely burdensome and inefficient, for both stakeholders and the regulator.
Health Canada proposes to create a single window digital portal to facilitate the reporting of loss and theft under the Controlled Drugs and Substances Act. For industry this portal would reduce burden and introduce greater efficiencies through the use of technology, streamlining reporting obligations and allowing for the submission of more reliable data. The online portal would be accompanied by guidance and procedures for use by the regulated parties. This measure would assist Health Canada in ensuring that controlled substances remain in legal distribution channels and not interfered with in valid commercial, medical and scientific activities.
Health Canada expects to implement this initiative in winter 2020. For further details, see:
- Health Canada's latest updates
Theme: Agile Frameworks
Regulatory frameworks that are flexible and less prescriptive to better respond to innovation and emerging risks, and reflect updated science and technology.
An agile framework is responsive to health products that are developed faster than traditional products, may involve complex data acquisition, storage, analysis and predictive capacities, have limited data available to support their safe use, are designed for individual patients, and evolve quickly. In addition, Health Canada wants to be in a position to take calculated and considered risks as a regulator that achieve the following results:
- permit Canadians access to the cutting edge technologies, which have the potential to protect, extend, or improve their quality of life;
- improve the rapidity and predictability of Health Canada's decisions on applications from regulated parties; and
- manage burden on regulated parties.
Stakeholder comments related to this theme have been grouped into five issues, for which action will be taken.
The licensing system for most health products is rigid and hard to understand
Industry stakeholders raised concerns that current frameworks regulating pharmaceuticals, biologics, radiopharmaceuticals, veterinary drugs and medical devices are outdated, inflexible, cumbersome and no longer aligned with the realities of their sector.
Health Canada has an interest in ensuring that regulatory frameworks for health products are flexible enough to accommodate the continuous change in the sector. Through amendments to the Food and Drug Regulations and Medical Devices Regulations, Health Canada is proposing to advance an adaptive, modern licensing scheme to effectively regulate health products throughout their lifecycles. Under the new framework, Health Canada would be better able to address innovative products using adaptive oversight, such as products targeting narrow patient groups for which less pre-market evidence may be available.
Greater flexibility in the licensing of products is expected to allow industry to rely on a balance between pre-market and post-market evidence, in certain cases.
This proposal is also linked to an initiative described in the Agri-food and Aquaculture Sector Regulatory Review Roadmap for the purpose of establishing an agile, life-cycle-based approach to licensing of veterinary drugs.
Health Canada anticipates advancing initial proposed regulatory amendments as follows:
Proposed amendments to the Food and Drug Regulations in Canada Gazette, Part I in fall 2021, and proposed amendments to the Medical Devices Regulations in Canada Gazette, Part I in spring 2022. These regulatory amendments would be targeted for final publication in the Canada Gazette, Part II in 2023.
For further details, see:
- Health Canada's latest updates
The establishment licensing scheme for drugs and medical devices is burdensome and does not facilitate export
Industry stakeholders have commented that predictable regulatory decision timelines are an important factor in deciding whether to market new drugs and medical devices in Canada. Delays in licencing can lead to companies bypassing the Canadian market entirely with their innovative products. They have also raised concerns about the reputation and competitiveness of Canada's drug and medical device export sectors, given the exemption of drugs and devices manufactured solely for export from most requirements in the Food and Drugs Act, and therefore subject to limited oversight. As such, foreign jurisdictions have limited assurance that exported products have been made according to Canada's requirements.
Health Canada proposes to address these concerns in two phases through amendments to the Food and Drug and Regulations and Medical Devices Regulations. The first phase would replace burdensome annual review requirements with less prescriptive and more flexible provisions. These changes would streamline the review process for issuing and reviewing establishment licences by reducing the amount of information required to be submitted. As well, this proposal would introduce terms and conditions for medical devices establishment licenses that may create new exemptions for start-up companies that utilize innovative programs operated and overseen by other government departments. Using terms and conditions in this manner would allow for new and innovative medical devices companies to begin operations sooner. The proposal would also address export requirements to improve the international reputation of the quality of drugs and medical devices that are exported from Canada.
The second phase would use a regulatory sandbox approach through the new advanced therapeutic pathway in the Food and Drugs Act to examine ways in which Health Canada could experiment with licensing the activity of producing the product, rather than licensing individual products. For example, it is not possible to treat personalized health products produced via 3D printing as medical devices that need to be licensed with Health Canada prior to use due to the unique nature of each printed product. For these types of advanced therapeutic products, it would be more appropriate to regulate the production activity through tailoring quality management requirements to the specific risks associated with 3D printing.
Health Canada anticipates pre-publishing the proposed regulatory amendments in the Canada Gazette, Part I in early winter 2020. Final publication of the regulatory amendments in Canada Gazette, Part II is anticipated in winter 2021. For further details, see:
- Health Canada's latest updates
The licensing scheme in the current regulations for controlled substances creates unnecessary burden
Licensed dealers of controlled substances have difficulties understanding and complying with certain aspects of the regulations for various classes of controlled substances relating to licences and permits. Licensed dealers commented that inconsistent requirements in those regulations cause undue administrative burden, requiring more frequent licence renewals and amendments and enabling only relatively short and inconsistent maximum validity periods for import and export permits.
Health Canada is streamlining and clarifying provisions pertaining to licences and permits in the relevant regulations. These amendments will ensure a modernized licensing scheme for all classes of controlled substances, increase the maximum duration of a licence from one to three years, and increase the validity of an import or export permit from three to six months.
Health Canada is working towards making the necessary changes to implement this initiative by publishing final regulations in Canada Gazette, Part II in spring 2019. For further details, see:
- Health Canada's latest updates
Regulations on controlled drugs and substances do not accommodate shifts in models of health care delivery
Health Canada heard from the health sector, including hospitals and health care facilities, that health care models are shifting from a primarily hospital-based environment to include other health care facilities like long-term care homes and palliative care facilities. The current regulations do not adequately accommodate this shift and a lack of regulatory oversight in these facilities is a known gap in mitigating the diversion of controlled substances.
Health Canada is proposing to modernize regulatory requirements to better reflect ways in which controlled substances are used within health care facilities. This would allow these facilities to achieve greater efficiencies without some of the barriers posed by outdated regulations and would support innovation in the area of healthcare service delivery. Health Canada anticipates pre-publishing proposed regulatory amendments in the Canada Gazette, Part I in fall 2020. For further details, see:
- Health Canada's latest updates
In addition, limited access to pharmacists in remote communities places limits on access to controlled substances required for medical purposes as only pharmacists are able to dispense controlled substances. These strict regulations decrease the efficiency of increasingly prevalent third-party prescription filling services that fill orders for other pharmacies ("central-fill pharmacy"), which can improve access to medicines for rural and remote communities.
Health Canada proposes to amend regulations to reflect the new operational realities of pharmacies and enable more innovation. These proposed changes will permit pharmacies to modernize processes to achieve efficiencies in healthcare service delivery through the deployment of technology across the business (e.g. enabling activities such as tele-pharmacy and central-fill). These proposed changes have the potential to reduce costs, improve patient compliance, reduce medication error and introduce economies of scale with automation. Modernizing the regulations would enable innovation in healthcare service delivery and pharmacy operations.
Health Canada is proposing to pre-publish the necessary regulatory changes in the Canada Gazette, Part I in fall 2020. Final publication of the regulatory amendments in Canada Gazette, Part II is anticipated in fall 2021. For further details, see:
The process to claim information as confidential for workplace chemicals is unpredictable and burdensome
The Workplace Hazardous Materials Information System (WHMIS) requires suppliers to disclose the chemical name and concentration of hazardous ingredients in their products on safety data sheets. The Hazardous Materials Information Review Act allows suppliers and employers to apply for exemptions from these disclosure requirements. Industry stakeholders have commented that the exemption claim process in Canada is unpredictable, burdensome and slow.
Workplace Hazardous Materials Information System (WHMIS) is a communications system to help Canadian workplaces safely use hazardous chemicals. Information is provided through product labels, safety data sheets and worker education programs.
Health Canada proposes to modernize the Hazardous Materials Information Review Act. As a result of the proposed amendments, businesses would be able to rely on a stable and predictable process when filing a claim for exemption. They can also expect to have information and decisions communicated in a more efficient and transparent way and in a format Canadians are familiar with. These amendments would reduce regulatory burden by removing unnecessary activities, including the lengthy and out-dated appeals process – thereby allowing businesses to directly file an application for Judicial Review, and introduce more nimble enforcement tools, to help ensure a level playing field for all businesses. While the proposed amendments support businesses, the changes would result in more effective protection of the health and safety of Canadian workers.
Proposed legislative amendments are being sought as part of the Budget Implementation Act, 2019. For further details, see:
- Health Canada's latest updates
Health Canada's Novel Approaches
Health Canada has identified two proposals that not only address issues raised by stakeholders, but will use new, more collaborative and flexible approaches to regulation.
Details of the policy, program and novel approaches identified below can be found on Health Canada's Program and Policy Initiatives and Novel Regulatory Approaches.
Enabling advanced therapeutic products
The health and biosciences sector is changing rapidly, particularly with respect to developing emerging technologies such as artificial intelligence, digital health, and 3D printing. The growing suite of advanced and/or personalized health products and therapies are increasingly challenging existing regulatory requirements. Stakeholders and Health Canada agree that the existing requirements are not well suited to the growing suite of advanced therapeutic products and therapies.
Health Canada is proposing to address this by introducing authorities for an advanced therapeutic products pathway in the Food and Drugs Act. This new scheme would enable the use of customized regulatory requirements that would allow the agility and flexibility necessary to determine the appropriate oversight of innovative health products. Minimizing barriers to market entry for the most advanced biomedical innovations that do not fit into the current regime would be examined, while making sure that effectiveness and safety are well-monitored and managed for best patient outcomes. The ability to create tailored authorization pathways for advanced therapeutic products would support timely access for patients, while optimizing safety and benefits, as well as strengthen innovation in the health and biosciences sector.
This initiative was announced in Budget 2019. Proposed legislative amendments are being sought as part of the Budget Implementation Act, 2019. The underlying policy work and the co-creation of a regulatory sandbox could be completed by early Winter 2021. For further details, see:
- Health Canada's latest updates
Re-testing requirements for imported lower risk drugs are duplicative and create administrative burden that outweigh the risk of the products
Health Canada is piloting reduced testing requirements for sunscreens imported from the United States, Mexico, Japan and countries for which Canada has a Mutual Recognition Agreement to verify there is no impact to health or safety. Industry has raised that the required re-testing and quarantine creates administrative burden and may reduce Canada's competitiveness in a global market.
Eliminating duplicative or unnecessary testing requirements reduces the operational costs and time associated with bringing a product to market in Canada without compromising the safety of Canadians. Close collaboration between industry and Health Canada will be continued throughout the expanded pilot to ensure the sharing of information. Timelines, scope and success indicators for the pilot will inform any changes to the regulatory framework for self-care products.
The pilot project was expanded in February 2019 and Health Canada proposes to formalize regulatory changes in 2020. For further details, see:
- Health Canada's latest updates
Sector Issues and Irritants not being addressed by Health Canada
Health Canada heard a number of suggestions from stakeholders during the consultations for this sectoral review that, while carefully considered, will not be addressed through this Roadmap for various reasons. These issues are outlined below, along with an explanation of why Health Canada will not take action at this time.
The following are areas within Health Canada's regulatory oversight that were recently reviewed and modernized, or are in the process of being modernized, and were therefore not included in the scope of the Review.
- Cannabis, tobacco and vaping
- Pricing of patented medicines
- Monitoring of medical assistance in dying
- Assisted human reproduction
- Cost recovery
- Regulation of radiation emitting devices, and the Canadian Environmental Protection Act, 1999
In these instances, consultations have either been ongoing parallel to the regulatory review process or additional time is needed to determine whether recently developed or implemented approaches have been effective before further adjustments are considered.
Health Canada is not currently able to take action to address all issues raised through the regulatory review consultation. Changes proposed to the following areas were carefully considered, but were not included as action items in this review:
- compliance and enforcement for consumer products
- data protection
- drugs for urgent public health needs
- multiple licences, inspections and reports
- implementation of the medical device single audit program
- record retention requirements for workplace chemicals
Suggestions put forward were excluded from the review if they would have unduly compromised our mandate to protect health and safety, have elicited divergent stakeholder views, or would have required agreements from foreign jurisdictions.
The completion of this sectoral roadmap represents an important milestone for Health Canada, however consultation with stakeholders will continue. Consideration will be given to other areas in the future, such as a thorough review of existing consumer product regulations, which could be considered for potential future rounds of regulatory review. Additionally, the department will move forward to address the stock review element of the Cabinet Directive on Regulation.
While it was not possible to address all suggestions received as part of the review process, it is expected that industry stakeholders across all product lines will be able to identify positive change from this Roadmap.
- Footnote 1
In this instance, the reference to the Health Portfolio includes: Health Canada, Public Health Agency of Canada, and Patented Medicines Price Review Board. It does not include reference to the Canadian Food Inspection Agency.
- Footnote 2
Canadian Agency for Drugs and Technologies in Health (CADTH) and Institut national d'excellence en santé et en services sociaux (INESSS) provide reimbursement recommendations respecting health technologies for provinces and territories.
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