ATP candidates

On this page

• What are suitable candidates
• How we identify candidates
• How you can suggest an ATP candidate
• Update on candidates

What are suitable candidates

ATP candidates are therapeutic products that are so unique, complex and distinct that they face a significant barrier under Health Canada's existing regulations.

Candidates that are suitable for a tailored ATP pathway may include:

• therapeutic products that are in pre-clinical and clinical stages of product development
• novel approaches to developing, manufacturing (centralized or decentralized) or distributing drugs and medical devices

How we identify candidates

To identify and choose candidates, we:

• conduct environmental scans
• consult stakeholders
• do a comprehensive analysis

Environmental scans on emerging or innovative technological, scientific or medical developments can help identify suitable candidates. These scans give an indication into what is currently happening in a rapidly evolving environment.

We involve stakeholders in several ways during this stage. Stakeholders include, for example:

• experts from Health Canada and other federal departments and agencies
• innovation hubs, innovators, drug and medical device industry and research stakeholders
• key health care system partners, provincial and territorial government and non-government bodies, and clinicians and hospitals
• other national and international regulators

Health Canada assesses the ATP candidates using a number of criteria:

• factors set out in regulations, if any
• other controls in place in existing legal frameworks and the extent that they are adequate to:
  • prevent harms to people or
  • prevent people from being deceived or misled
• novelty of the advanced therapeutic product compared to therapeutic products that are authorized
• risks and benefits of the ATP, including the measures that are available to adequately manage and control those risks

These are not criteria that must be met, but items we would consider to help us make a decision about an ATP candidate. The main item is whether a particular product could be regulated by the existing regulations. If there are doubts about this, we would conduct a comprehensive analysis.

The ATP framework is only 1 mechanism for bringing unique products to the Canadian market. After a comprehensive analysis, we may identify more appropriate mechanisms for specific products, such as a regulatory amendment, a guidance document update or a policy approach.

How you can suggest an ATP candidate

You may propose an ATP candidate. To do so, use the following form:

• ATP Candidate Identification Form

We will review and consider your suggestions. Some may be analyzed, while others may be placed in our environmental scan list. They may be good candidates at a future date.

Update on candidates

We are analyzing a number of advanced therapeutic products as candidates for this approach.

To date, we have looked at 2 possible candidates:

• adaptive machine learning-enabled devices (MLMDs) and
• fecal microbiota therapy for Clostridium difficile infection

Adaptive machine learning-enabled devices

We first identified adaptive MLMDs as a potential candidate in 2021. Since then we have learned more about these complex medical devices from stakeholders and our regulatory counterparts in other countries. We have decided that policy updates to the existing regulations are sufficient. We published a guidance on MLMDs that outlines pre-market considerations for these devices.

Learn more:

• Pre-market guidance for machine learning-enabled medical devices

Fecal microbiota therapy

We also looked at fecal microbiota therapy for treating Clostridium difficile infection as another candidate. Following a comprehensive analysis, we are now deciding on next steps. We will make our decision based on:

• discussions with stakeholders
• international regulatory frameworks
• the current status of fecal microbiota therapy as a commercial product