What we heard: Agile regulations for advanced therapeutic products and clinical trials

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We have undertaken extensive consultations and environmental scanning. The Health and Biosciences Sector Regulatory Review gave us an opportunity to further understand regulatory barriers to innovation in Canada. This allowed us to define a plan for more agile regulations that can keep pace with new:

The Health and Biosciences Sector Regulatory Review Roadmap outlined a number of regulatory modernization commitments. These included plans to modernize the regulations for clinical trials and advanced therapeutic products (ATPs).

We asked for feedback on these modernization efforts by posting a discussion paper online from June to September 2019.

We asked stakeholders 3 questions:

  1. What products would you want us to put forward for consideration under the ATP pathway?
  2. Can you suggest any good models of an enhanced client “concierge” service that would help companies wishing to be considered for the ATP pathway?
  3. What recommendations do you have for creating clinical trials regulations that would attract clinical trials to Canada and be an effective model in the Canadian context?

Feedback on the Advanced Therapeutic Product (ATP) Pathway

Health product innovations – including new methods of design, manufacture and use – are challenging our existing regulations. These include ATPs, drugs, devices, or a combination of both so novel, complex, and distinct that the current regulations aren’t equipped to handle them. Many blur the lines between traditional product classifications.

In addition, the growing number of personalized medicines can present regulatory challenges. For example, cell therapies prepared at the bedside and given to a specific patient for whom they are designed. These products fall outside the standard health care model, where drugs are:

As part of our regulatory innovation plan, we established a new pathway for ATPs. This follows the addition of new legislative provisions to the Food and Drugs Act (FDA) in June 2019. The new pathway will permit authorizing ATPs in a flexible and risk-based manner, with requirements tailored to ATPs’ unique characteristics.

We will only use the pathway when existing regulatory frameworks under the FDA cannot accommodate a product appropriately. Health Canada will consider potential candidates on a case-by-case basis, guided by criteria in the new legislative provisions. We will continue to regulate most drugs and devices under existing frameworks.

To help develop this new pathway, we asked stakeholders what products they would put forward for consideration. The most common product suggestions were related to:

Additional suggested products included:

Stakeholders gave additional advice on how we might prioritize products for the ATP pathway. Their recommendations included prioritizing products:

Feedback on concierge service to support the ATP Pathway

Innovators and industry will need guidance to navigate the new ATP pathway. We are planning to develop a specialized “concierge” service to better serve this need. In responding to the discussion paper, stakeholders discussed what they would like to see in this service.


Stakeholders recommended an equitable approach between small and large innovators. Small innovators may need more time and resources to understand and meet regulatory information and submission requirements. Crucially, the concierge should guide innovators through the entire ATP process and provide assistance in gaining market access.

Leveraging knowledge

Stakeholders further recommended a concierge with intimate knowledge of the ATP pathway and its criteria. The concierge should be able to:


Stakeholders suggested that the concierge operate as a free and accessible single window. Contact should be through human interaction, like a phone line or central online portal.

Engagement from stakeholders

The concierge should liaise with stakeholders who support or are part of the development and market access of ATPs. This includes engaging with others in the Canadian health and innovation ecosystem, such as:

The concierge would also liaise with the various pre- and post-market areas of Health Canada, including those responsible for:

Other concierge models

Stakeholders submitted models of concierge services from Canada and other jurisdictions for review. These included:

As we develop the concierge service for the ATP pathway, we will:

Feedback on clinical trial modernization

Clinical trials are an important first step in health product development. Due to evolving product complexity, there is a need for more flexible approaches to clinical trial types and designs. Studies increasingly focus on individual treatments rather than groups, with new technologies and data changing how studies are conducted. We are working to modernize our regulations to increase flexibility and risk-based oversight to:

We asked stakeholders for recommendations on how to create regulations that would:

Stakeholder input centred on several key themes.

Greater flexibility

Stakeholders recommended greater flexibility to accommodate innovations in how trials are conducted. This flexibility would also better meet patient needs to help them to participate in trials. Examples of how to achieve this included:

Risk-based oversight

Stakeholders highlighted risk-based oversight as an approach that could foster more clinical trials in Canada. This oversight would be based on less stringent regulatory requirements and reduced administrative barriers. For example, a risk-based approach to audit activities would:

Stakeholders further discussed how investigator-initiated trials with marketed therapeutics for off-label uses might be considered lower risk. They also discussed not being subject to the same application and reporting requirements as a new trial.

Assisting clinical trial conductors

Stakeholders suggested enhancing the assistance Health Canada provides to innovators who conduct clinical trials. This could take the form of education on trial processes and requirements, as well as guidance on:

Working together

Stakeholders also recommended increased international alignment and harmonization. This would:

Stakeholders asked Health Canada to continue to enhance its work as a central coordinator in the Canadian health innovation ecosystem. This will continue to foster connections between stakeholders and further collaboration.

Staying connected and learning more about regulatory innovation

The feedback we received from stakeholders throughout consultations will continue to inform Health Canada’s work as:

Stay connected and learn more by visiting Health Canada’s Regulatory Innovation Agenda webpage.

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