Health and Biosciences: Targeted Regulatory Review

Health Canada has made a number of advancements in implementing the Health and Biosciences Roadmap. Below is a summary of the key thematic outcomes and updates on specific initiatives. You will also find a link to earlier updates (February 2021).

Key outcomes

Integrated regulatory frameworks to improve consistency and predictability across product categories

Health Canada is advancing initiatives that address stakeholder concerns with differing requirements for similar types of products based on outdated risk profiles. For instance, we published final amendments to the Natural Health Products Regulations to improve labelling of natural health products in July 2022.

We are also working to amend 3 different sets of regulations (for natural health products, non-prescription drugs and cosmetics). This will enable a more risk-based approach to address oversight for self-care products and the misalignment of regulatory requirements.

These changes are part of Health Canada's modernized self-care framework.

A global approach to improve efficiency and reduce regulatory burden by leveraging partnerships with international regulators

In recognition of the increasingly global nature of the health sector, Health Canada is advancing initiatives to align Canadian regulations with international partners where appropriate.

For example, in 2021, Health Canada began advancing amendments and consulting stakeholders on Canada's drug exports and transshipments requirements. This will align the Canadian regulation of exported drugs to that of international partners and help maintain Canada's status as a manufacturer of high-quality drugs. Regulatory amendments to the Food and Drug Regulations were published in the Canada Gazette, Part Iin June 2021, with final regulations published in the Canada Gazette, Part II in June 2022.

Another example is the amendment to the Food and Drug Regulations and Natural Health Products Regulations made in February 2022 to reduce the number of years from 25 to 15 that industry must hold records for clinical trials. This is expected to save industry up to $9 million per year. This is in addition to a one-time retrospective cost saving of between $177 and $372 million from clinical trials currently holding records. These changes better align requirements with other jurisdictions, which will encourage clinical trials to be conducted in Canada and help to increase people's access to novel therapies.

In July 2020, Health Canada published information for regulated parties on the enforcement approach for the general prohibition under the Canada Consumer Product Safety Act. This aimed to improve regulatory transparency by providing clarity to industry around our expectations for the safety of products that are not on products that are not covered by product-specific regulations. By sharing performance criteria, this publication has helped to reduce hazards related to consumer products.

Since that time, 10 product categories have been identified under the general prohibition that pose a danger to human health and safety if they fail to meet specified performance criteria.

Adopting a more risk-based approach to reduce burden and effectively deploy resources

Health Canada is advancing initiatives that are moving regulatory regimes away from a one-size-fits-all approach.

For example, to introduce greater flexibility in the safe development of innovative therapies, we examined opportunities to streamline regulations across the lifecycle of clinical trial application and post-authorization processes across several product types, ranging from medical devices to drugs. The interim orders created in response to the pandemic in May 2020 were designed to make the authorization process for COVID-19-related clinical trials more efficient. They also enabled Health Canada to pilot and demonstrate the value and feasibility of some features that were being considered under this initiative, such as combining multiple trial phases into a single trial application.

Creating more agile, flexible frameworks to better support innovation and manage emerging risks

Health Canada recognizes that many innovative health products have unique characteristics, such as complex data acquisition or predictive capabilities. They also evolve more quickly than traditional products. Roadmap initiatives under this theme will help improve our ability to take calculated and considered risks regarding innovative health products. This will allow Health Canada to make more timely decisions on applications from regulated parties and improve people's access to cutting-edge technologies.

For instance, in 2021, Health Canada consulted stakeholders on proposed regulatory amendments for licensing drugs and medical devices. In December 2022, we pre-published the proposed amendments that would make the process more agile under this initiative in the Canada Gazette, Part I.

Health Canada is suggesting an approach that will balance the need to provide the people of Canada with timely access to new and innovative technologies/drugs with the need for appropriate levels of pre-market and post-market oversight. Applying terms and conditions on authorizations for drugs and medical devices will ensure drugs and medical devices are safe and effective.

It is envisioned that these agile, flexible frameworks will help Health Canada respond better to the rapid pace of innovation with these products while ensuring they are safe, effective and of good quality.

Novel regulatory approaches

As part of efforts to advance novel approaches, Health Canada advanced proposals that use new, more collaborative and flexible approaches to regulating. For instance, we introduced new authorities in the Food and Drugs Act through legislative changes in the Budget Implementation Act, 2019. These authorities created a new framework to authorize advanced therapeutic products (ATPs). ATPs are drugs or devices that are developed, fabricated and delivered to consumers in novel ways that current regulations were not designed to handle. Health products that make use of 3D printing are an example.

Health Canada launched a 75-day public consultation on the advanced therapeutic products framework guidance document in December 2022. We received 10 sets of stakeholder comments (119 comments in total), which are currently being reviewed. We will revise the guidance document based on the feedback received.

Finally, the Health and Biosciences Roadmap has played a role in supporting Canada's pandemic response and recovery and in strengthening future emergency preparedness. For example, Health Canada is implementing regulatory flexibilities for the licensing for drugs and medical devices, building on lessons learned through interim orders applied in response to COVID-19. As a result of these flexibilities, such as simplified application pathways and the introduction of broad terms and conditions powers for COVID-19 therapeutic products, we helped:

support over 800 medical devices to gain market access
support over 4,450 new hand sanitizers onto the market
Canada be one of the first countries in the world to approve 5 COVID-19 vaccines

Considerations

The COVID-19 pandemic had an impact on Health Canada's ability to implement a few initiatives identified in the Roadmap. For example, we had to re-direct available resources to support our COVID-19 response. Our main focus during the pandemic was to make sure that people in Canada had access to the critical products and devices they needed. Thus, roadmap initiative implementation challenges included resource constraints and a limited stakeholder engagement due to the pandemic.

Despite these challenges, roadmap initiatives continue to support reducing burden, aligning with international partners and introducing measures that help to increase regulatory flexibility in the health and biosciences sectors.

Updates on specific initiatives

Regulatory modernization to enable software as a medical device

To improve the regulation of medical devices throughout their lifecycle, Health Canada explored different ways to appropriately regulate adaptive machine learning-enabled medical devices (MLMD).
In September 2023, new draft guidance was published for public consultation. It will outline expectations for application information to be provided for MLMD, including considerations for adaptive MLMD.
Health Canada will also continue to monitor and engage in technical and international developments on the regulation of software as a medical device.

Introduce a risk-based approach for self-care products

To advance a modernized self-care framework, Health Canada is proposing regulatory amendments to make it easier for non-prescription drugs to access the market. The amendments also introduce a risk-based approach to regulatory oversight for all self-care products.
In summer 2021, Health Canada published a notice to interested parties on the proposal to amend the Cosmetic Regulations. The proposed Regulations Amending Certain Regulations Concerning the Disclosure of Cosmetic Ingredients were published in the Canada Gazette, Part I on February 11, 2023. We plan to publish the amended regulations in the Canada Gazette, Part II in spring 2024.
On July 6, 2022, Health Canada published final amendments to the Natural Health Products Regulations in the Canada Gazette, Part II. We also updated guidance on the labelling of natural health products and evidence for homeopathic medicines.
On December 8, 2022, Health Canada launched the Non-Prescription Drug Action Plan. This plan advances the concepts of the self-care framework by reducing burden where possible and aligning the level of oversight of non-prescription drugs with their level of risk through policy and operational changes to fast-track their market access ahead of regulatory amendments.
On June 22, 2023, the government passed legislation to amend the Food and Drugs Act. This extended powers conferred by the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) to natural health products. With these changes, Health Canada will be able to protect the health of people in Canada by taking stronger action when serious health or safety issues are identified with natural health products on the market.

Alignment of clinical trial records retention timelines

Health Canada published a notice of intent in December 2020 on proposed amendments to the Food and Drug Regulations and the Natural Health Products Regulations and published regulatory amendments in the Canada Gazette, Part II on March 2, 2022.
The amendments reduce the number of years from 25 years to 15 years that industry must hold records and is expected to save sponsors between $4.2 million and $8.9 million per year. There is also an additional one-time retrospective total sponsors' cost savings expected between $177 million and $372 million from clinical trials sponsors currently holding records.
This initiative is complete.

Clarifying and aligning recall requirements

Health Canada is proposing to amend both the Food and Drug Regulations and the Medical Devices Regulations to update existing recall requirements. This would establish clear responsibilities for industry on how to report recalls and align medical device recall reporting requirements with those in the United States.
The proposed amendments to the recall reporting requirements are expected to address industry and stakeholder concerns on international alignment for both the Medical Devices Regulations and the Food and Drug Regulations. Consultations with public and industry stakeholders for the recall portion of this package were completed through a notice of intent published in the Canada Gazette, Part I on December 11, 2021, for a 60-day consultation period. The Regulations Amending the Food and Drug Regulations and the Medical Devices Regulations (Recalls, Establishment Licenses and Finished Product Testing) were pre-published in the Canada Gazette, Part I on April 15, 2023.
Health Canada plans to publish the final amendments in the Canada Gazette, Part II (part of the modernizing drugs and medical devices establishment licensing frameworks initiative, #10 in the public roadmap) in spring 2024.

Optimizing choice of instrument for consumer products

This initiative, which is now complete, involved clarifying the process for improving the safety of consumer products.
Health Canada published the instrument choice framework for the Canada Consumer Product Safety Act in June 2021. The framework sets out considerations and process for determining which regulatory tool or instrument would be used to address a consumer product safety risk.
Health Canada also published information for regulated parties on the enforcement approach for the general prohibition under the Canada Consumer Product Safety Act. This information gives industry a clear indication of our expectations for product safety on unregulated products or known unregulated hazards.

Modernization of the regulation of clinical trials

Health Canada consulted stakeholders on the clinical trials regulatory modernization initiative from May to July 2021 and published a What We Heard Report in February 2022 summarizing feedback.
Health Canada also consulted stakeholders on a proposed regulatory framework for clinical trials on food for a special dietary purpose. A What We Heard Report on the framework was published in February 2022.
Health Canada expects to pre-publish the proposed clinical trial regulations and make corresponding amendments to the Food and Drug Regulations, Natural Health Products Regulations and the Medical Devices Regulations in the Canada Gazette, Part I within the next few years.

Removing barriers around the distribution of drug samples

On July 1, 2020, legislative amendments to the Food and Drugs Act and regulatory amendments to the Food and Drug Regulations and the Natural Health Products Regulations came into force. Health Canada produced a guidance document to help stakeholders interpret these new legislative and regulatory requirements.
This initiative is complete.

Electronic reporting portal for controlled drugs and substances

Health Canada tested a single window digital portal in winter 2020 to help stakeholders report loss and theft under the Controlled Drugs and Substances Act. In November 2021, we launched the public facing portal for stakeholders to self-enroll.
This initiative is complete.

Flexible lifecycle-based licensing for drugs and medical devices

Health Canada consulted stakeholders on the Agile Regulations for Licensing Drugs and Medical Devices proposal through a notice of intent published in the Canada Gazette, Part I on July 31, 2021.
Health Canada developed a regulatory package under the agile licensing regulatory proposal. This was pre-published in the Canada Gazette, Part I on December 17, 2022, along with multiple supporting draft guidance documents for comment. We plan to publish the final regulations in the Canada Gazette, Part II in spring 2024.
On May 7, 2022, Health Canada pre-published a proposal in the Canada Gazette, Part I to consult on new regulations for biocides under the Food and Drugs Act. We also sought feedback on a related draft guidance document. We held a separate consultation for a proposal to amend the Fees in Respect of Drugs and Medical Devices Order to introduce new fees for biocides.
Health Canada is considering plans for additional modernization of the Food and Drug Regulations and the Medical Devices Regulations beyond the commitments made under this roadmap initiative.

Modernizing drugs and medical devices establishment licensing frameworks

Health Canada published regulatory amendments to the Food and Drug Regulations on exports and transhipments of drugs in the Canada Gazette, Part II on June 8, 2022.
Health Canada is planning 2 phases of amendments to the medical device establishment licensing (MDEL) framework and drug establishment licensing (DEL) framework.
Phase I of amendments to the Medical Devices Regulations and Food and Drug Regulations were pre-published in the Canada Gazette, Part I on April 15, 2023. Final publication in the Canada Gazette, Part II is targeted for spring 2024.
For Phase II, the DEL framework package is targeting fall 2023 for pre-publication in the Canada Gazette, Part I and fall 2024 for final publication in the Canada Gazette, Part II. The MDEL framework is targeting fall 2024 for pre-publication in the Canada Gazette, Part I and fall 2025 for final publication in the Canada Gazette, Part II.

Modernizing regulations under the Controlled Drugs and Substances Act with respect to licences and permits

This initiative is complete.
Health Canada modernized the regulations for licences and permits under this act. For more information, refer to the February 2021 progress update.

Modernizing regulations under the Controlled Drugs and Substances Act with respect to pharmacists, hospitals and other health care facilities

Health Canada plans to pre-publish the proposed new Controlled Substances Regulations in the Canada Gazette, Part I in spring 2024.

Modernization of the Hazardous Materials Information Review Act

This initiative is complete.
Health Canada modernized the regulations for the registration and review of claims for exemption from information disclosure requirements related to confidential business information. For more information, refer to the February 2021 progress update.

Enabling advanced therapeutic products

Health Canada identified 2 potential candidates for the advanced therapeutic product (ATP) framework in spring 2021:
- adaptive machine learning-enabled medical devices (MLMD)
- fecal microbiota therapy (FMT) for recurrent Clostridium difficile infection

External reference groups then met in summer and fall 2021 to help develop tailored regulatory requirements for these candidates.

In January 2022, Health Canada posted a new ATP webpage to give information about the ATP framework, candidates being considered, stakeholder engagement and next steps.
In December 2022, Health Canada published a draft ATP Framework guidance for public consultation.
While work on other ATP candidates continues, Health Canada has determined that the use of an ATP pathway is not required to regulate MLMD. We intend to use existing regulations and authorities to oversee MLMD.
Health Canada is exploring the candidacy of other product classes for inclusion in the ATP framework. We are looking at options to find the best way for fecal microbiota therapy to move forward as an ATP candidate.

Exploring reduction of duplicative requirements for imported lower-risk health products (sunscreen pilot)

This initiative is complete.
Health Canada modernized the regulations for licenses and permits under this act. For more information, refer to the February 2021 progress update.

Archived updates

February 2021

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Date modified:: 2023-11-07

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