Health and Biosciences: Targeted Regulatory Review
Published: January 2021
Last update: January 2021
Since the launch of the Health and Bioscience Sector Regulatory Review Roadmap (Roadmap), Health Canada has made great strides in advancing work on the 16 identified initiatives. These updates to the Roadmap initiatives provide an overview of the work that has been undertaken, as well as the next steps to implement these commitments.
While the COVID-19 pandemic has impacted progress on Health Canada’s plans outlined in the Roadmap, it has also reinforced the need for regulatory agility and flexible approaches to health product oversight. In its response to the pandemic, Health Canada launched temporary emergency measures that helped companies in the health and biosciences sector bring urgently needed health products, including medical supplies for COVID-19, to market. These temporary measures have provided an opportunity to pilot many of the agile regulatory solutions planned as part of Health Canada’s Roadmap. Health Canada will use this experience to inform policy and regulatory development as implementation of Roadmap commitments continue.
Revised timelines for all regulatory initiatives can be found in Health Canada’s Forward Regulatory Plan.
- In response to stakeholder concerns surrounding regulatory requirements on software medical devices, Health Canada published a guidance document on Definition and Classification of Software as a Medical Device (SaMD) in December 2019 as an initial step to address the challenges around “current medical device requirements creating barriers for a changing industry”. Moving forward, Health Canada is proposing amendments to the Medical Devices Regulations to implement an agile, modern licensing scheme to more effectively regulate medical devices throughout their lifecycle. These amendments will be advanced through the “Agile Licensing for Medical Devices” regulatory proposal. Stakeholders will be consulted in advance of the pre-publication of the proposed amendments in Canada Gazette, Part I, which is targeting spring 2022.
- To help address stakeholder concerns that “self-care products are subject to varying regulations”, Health Canada is proposing amendments to the Food and Drug Regulations to introduce a risk-based approach to the regulatory oversight of non-prescription drugs. These proposed amendments will be advanced as part of the “Agile Licensing for Drugs” regulatory proposal. Consultations with stakeholders will continue in advance of pre-publication of proposed regulatory amendments in Canada Gazette, Part I, which is targeting spring 2022.
- Health Canada undertook policy consultations and stakeholder engagement in winter 2020 as part of its proposal to reduce clinical trial records retention requirements from 25 years to 15 years. Health Canada is considering exceptions to the shortened retention period and may require a longer retention period for clinical trials posing elevated long-term risks to patient safety. In December 2020, Health Canada published a Notice of Intent with a 45-day comment period to inform stakeholders of the proposed policy direction, and to confirm the proposed amendments reflect stakeholders’ needs while still offering an appropriate level of protection for Canadians.
- Health Canada continues to move forward on the proposed amendments to the Food and Drug Regulations, and Medical Devices Regulations to clarify roles and responsibilities in recalls, as well as align recall reporting requirements with those in the United States. Public and industry stakeholders will be further consulted through the pre-publication of the proposed regulatory amendments in Canada Gazette, Part I, which is targeting spring 2022.
- Health Canada is developing an Instrument Choice Framework that would set out the considerations for how it determines which regulatory tool or instrument will be used to address a consumer product safety hazard. Stakeholders were consulted on the public-facing Instrument Choice Framework in fall 2020. Health Canada expects to publish the final version of the Instrument Choice Framework in winter 2021.
- On July 1, 2020, amendments to the Food and Drugs Act, the Food and Drug Regulations and the Natural Health Products Regulations came into force to allow for the distribution of samples of certain low risk non-prescription drugs and natural health products, and to expand the list of practitioners permitted to distribute drug samples. Health Canada published a guidance document to assist stakeholders with interpreting these new legislative and regulatory requirements. This completes Health Canada’s commitment in the Roadmap initiative “limitations on the distribution of drug samples are causing barriers to access for Canadians”. In administering these new regulations, Health Canada will continue to engage with stakeholders on how and when the list of non-prescription drugs that can be distributed as samples can be expanded.
- As part of the Budget Implementation Act, 2019, necessary legislative provisions were introduced to the Food and Drugs Act to support the modernization of the clinical trial regulations, as described under the initiative “clinical trial regulations are limiting growth”. Over the course of 2019 and 2020, Health Canada engaged with stakeholders on clinical trial modernization objectives. As part of Health Canada’s regulatory response to the COVID-19 pandemic, concepts from this proposal were piloted. Applicable lessons learned will help inform modernisation in this area. Consultation will continue in 2021-2022. Public and stakeholders will also have the opportunity to comment through the pre-publication of the proposed regulatory amendments in Canada Gazette, Part I, which is targeting spring 2022.
- Health Canada is creating a single window digital portal to facilitate the reporting of loss and theft under the Controlled Drugs and Substances Act. Health Canada began on-boarding stakeholders in February 2020 and continues to on-board stakeholders as part of this pilot project. Once a critical level of onboarding in the pilot is reached, the portal will be available to all stakeholders in winter 2021.
- Health Canada has fulfilled its commitments related to streamlining and clarifying provisions pertaining to licences and permits in the relevant regulations under the Controlled Drugs and Substances Act. In particular, these regulatory amendments helped modernize the licensing scheme for all classes of controlled substances, including by increasing the maximum duration of a licence from one to three years, and increasing the validity of an import or export permit from three to six months. The final regulatory amendments were published in Canada Gazette, Part II, on June 12, 2019, and came into force on December 9, 2019.
- In fulfillment of Health Canada’s commitments to modernize the Hazardous Materials Information Review Act, specifically the exemption from disclosure requirements, legislative amendments were completed as part of the Budget Implementation Act, 2019. On March 18, 2020, an Order in Council brought the legislative amendments to Hazardous Materials Information Review Act into force. This initiative is complete.
- In response to stakeholder concerns that “the licensing system for most health products is rigid and hard to understand”, Health Canada is proposing to develop an adaptive, modern licensing scheme that will regulate health products and devices throughout their lifecycles. Moving forward, Health Canada plans to proceed with two proposals: “Agile Licensing for Drugs” (including pharmaceuticals, biologics, radiopharmaceuticals and veterinary drugs) and “Agile Licensing for Medical Devices”. As part of Health Canada’s regulatory response to the COVID-19 pandemic, concepts from these proposals were piloted and applicable lessons learned will help inform their advancement. Stakeholders will be consulted in advance of the pre-publication of the proposed regulatory amendments in Canada Gazette, Part I, which is targeting spring 2022 for both proposals.
- As part of its proposal to modernize Drug and Medical Device Establishment Licensing Frameworks, Health Canada is putting forward three regulatory proposals.
- The first proposal focuses on changes associated with exports and transshipments of drugs, and is currently targeting the pre-publication of the proposed regulatory amendments to the Food and Drug Regulations in Canada Gazette, Part I in spring 2021.
- The second proposal focuses on modernizing medical device establishment licensing and is currently in the policy development stage. Public and industry stakeholders will be consulted through the pre-publication of the proposed regulatory amendments Part I, which is targeting spring 2022.
- The third proposal focuses on amendments to the Food and Drug Regulations to modernize drug establishment licensing as part of the initiative: “the licensing system for most health products is rigid and hard to understand”. Public and industry stakeholders will be consulted through the pre-publication of the ”proposed regulatory amendments” in Canada Gazette, Part I, which is targeting fall 2021.
- Health Canada is looking 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. To minimize burden on the health care system in the midst of a global pandemic, Health Canada will delay publication of a Notice of Intent until implicated stakeholders (e.g., hospitals and other health care professionals) have the capacity to engage on the proposed regulatory amendments. Health Canada is currently targeting publication of the Notice of Intent in spring 2021.
- Health Canada is also proposing to amend regulations on controlled drugs and substances to better support the operational realities of pharmacies, enable more innovation, and bring greater clarity and consistency across the regulations. As part of this, Health Canada issued a Notice to Interested Parties in 2019, which initiated a 60-day public comment period ending on May 7, 2019. Public and industry stakeholders are expected to be consulted again through the pre-publication of the proposed regulatory amendments related to pharmacies in the Canada Gazette, Part I, which is targeting in fall 2021.
Health Canada's Novel Approaches
Additional details can be found on Health Canada's Program and Policy Initiatives and Novel Regulatory Approaches.
- Health Canada completed legislative and regulatory amendments to allow for the distribution of samples of certain low-risk natural health products and non-prescription drugs that meet the necessary regulatory requirements. The Regulations Amending the Food and Drug Regulations (Finished Product Testing) were published in Canada Gazette, Part II on April 29, 2020 and came into effect on July 1, 2020. Health Canada is proposing to expand the list of certain non-prescription drugs for which testing requirements do not apply. Public consultations were held from August to October 2020.
- Under the initiative “enabling advanced therapeutic products”, Health Canada is implementing a new regulatory pathway for advanced therapeutic products. Legislative changes in the Budget Implementation Act, 2019 introduced new authorities in the Food and Drugs Act that enable the use of customized regulatory requirements to allow the agility and flexibility necessary to determine the appropriate oversight of innovative health products. It is anticipated that the underlying policy and operational work to implement this new pathway, including the identification of a pilot for the first regulatory sandbox, will be completed by the end of 2021.
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