Regulating advanced therapeutic products

Advanced therapeutic products

Advanced therapeutic products (ATPs) are drugs or devices, or any combination of drugs and devices, that our current regulations were not designed to handle because they're so complex or distinct.

Scientific and technological advances are speeding the pace of change in health care. This is leading to innovative health products that are:

personalized
developed at point of care
manufactured, distributed and used in ways that differ significantly from traditional health products

Canada's regulatory approach for advanced therapeutic products

Legislative provisions introduced in the Food and Drugs Act from June 2019 created a new framework to authorize ATPs.

This framework allows Health Canada to customize regulatory requirements for these products to:

maintain appropriate, yet flexible, regulatory oversight
promote innovation in drug and medical device development
ensure high standards for patient safety, product quality and efficacy and effectiveness
reduce barriers to bringing ATPs to market in Canada, thus providing access to new, potentially life-changing treatments

We will continue to regulate most drugs and devices within our existing regulatory frameworks. The new framework will provide the ability to authorize ATPs in a flexible and risk-based manner for products that significantly challenge our current system.

How the framework will work

In assessing whether a product may be eligible for the framework, Health Canada will consult with stakeholders and consider factors such as:

the risks and benefits associated with the product, and steps available to manage and control these risks
how different the product is from already approved drugs or devices
whether there are other appropriate controls in place, for example through provincial and territorial legislation

Regulating products in the ATP framework will require consultation and collaboration with:

those directly involved in the development and use of these products, such as:
- patients
- industry
- academia
- innovators
- hospitals and clinics
health system partners including:
- health technology assessment bodies
- provincial and territorial representatives
international regulators

This will allow for a transparent process and the development of tailored requirements to allow access to the product or class of products in Canada. Furthermore, early alignment and coordination with these groups supports access to and adoption of these products within the health care system.

If a product or class of products qualifies for the ATP framework, the Minister of Health will add it to Schedule G in the Food and Drugs Act. Once an item is added to Schedule G, there are 2 ways to access the tailored ATP pathways:

a licensing scheme that requires authorization from Health Canada before marketing a product in Canada
an order of permission where conditions must be met before the product can be put on the Canadian market

In addition to customized authorization requirements, under the licensing scheme, the Minister can impose terms and conditions to each product licence. These terms and conditions:

may allow earlier access to promising therapies
will ensure appropriate oversight to mitigate risks

Health Canada will tailor an oversight framework for post-market obligations for each ATP.
Health Canada, in collaboration with the sponsor(s), will monitor the safety and effectiveness of ATPs. We can amend tailored requirements and terms and conditions as we gain new information and experience. We can suspend or cancel licences if deemed necessary.

Lastly, Health Canada can amend existing regulations or develop new regulations for the ATP after we have gathered enough experience with how we need to regulate the ATP.

International harmonization

Health Canada recognizes the importance of harmonizing requirements internationally, and has the ability to leverage what has worked well in other jurisdictions using the ATP framework.

Enhanced support for innovators

Innovators and industry will need guidance to navigate the new framework. To serve this need, we plan to offer a specialized "concierge" service for the ATP framework. Users will have a point of contact for direct, well-informed interactions with a Health Canada representative for ATP products through this enhanced level of service.

Candidates

Health Canada takes an early and collaborative approach to stakeholder engagement to identify potential ATPs.

The department relies on stakeholder input to help evaluate a number of technology areas as potential candidates for the ATP framework. The department:

uses environmental scans and stakeholder feedback to identify candidates
consults with key internal and external partners to evaluate candidates against the ATP criteria

In 2021, adaptive machine learning-enabled medical devices (aMLMDs) were identified as potentially needing a different regulatory approach. Using an external reference group, Health Canada gained insight and increased knowledge of these complex devices, which informed the development of a tailored regulatory approach. However, our continued analysis and engagement with stakeholders, as well as international developments from regulatory counterparts, led us to the conclusion that the existing regulatory framework could appropriately oversee these products with some policy updates. As a result, we developed a new draft guidance on MLMDs. For more information, stakeholders are encouraged to visit the public consultation.

In 2021, work was also undertaken on a second ATP candidate: fecal microbiota therapy for Clostridium difficile infection. Following an in-depth analysis, the options are being analyzed to determine the best way forward, taking into consideration:

engagement with stakeholders
international regulatory frameworks
the current status of commercialized development of fecal microbiota therapy

Health Canada continues to explore the candidacy of other product classes for the ATP framework.

Transparency

Health Canada is committed to transparency and openness to strengthen trust in our regulatory decisions. Health Canada will apply these principles to ATPs as appropriate. For example, stakeholders will continue to:

be involved in proposing ATP candidates
inform the tailored regulatory pathway that is developed for each ATP

Health Canada is committed to communicating information concerning ATPs to the public. The most up-to-date information will be available on this web page.

Opportunities for comment

Health Canada published a draft guidance document on the advanced therapeutic products framework for stakeholder comment on December 28, 2022.

The department will engage stakeholders as it develops the tailored requirements for ATP candidates.

We encourage stakeholders to contact us with questions and feedback regarding ATPs.

Contact us

Biologic and Radiopharmaceutical Drugs Directorate
Health Products and Food Branch
E-mail: atp-ptn@hc-sc.gc.ca

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Date modified:: 2023-09-26

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