Using the advanced therapeutic products framework

On this page

• Developing a tailored ATP pathway
• Using a tailored ATP pathway
• Monitoring ATPs
• Closing a tailored ATP pathway

Developing a tailored ATP pathway

Health Canada will use the ATP framework when we need to test tailored requirements to determine the appropriate level of oversight for an ATP candidate. These requirements form part of a tailored pathway for ATP candidates.

The steps to developing a tailored pathway are as follows:

• consult with stakeholders to develop tailored requirements
• develop a draft guidance document
• consult with stakeholders to propose adding a therapeutic product to Schedule G of the Food and DrugsAct (act) and draft guidance document
• finalize the guidance document based on stakeholder feedback
• propose adding the therapeutic product to Schedule G of the act and publish the final guidance document

The guidance document may include:

• pre-market requirements that are anticipated
• examples of post-market terms and conditions
• instructions on how to file an application for an ATP licence
• information related to an order of permission

Using a tailored ATP pathway

An authorization is required to conduct 1 or more of the following activities for an ATP:

• manufacture
• prepare
• preserve
• package
• label
• test
• store
• import
• advertise
• sell

An authorization can be in the form of an:

• ATP licence
• order of permission or
• authorization through the applicable schemes set out in regulation under the act

A person may be authorized to conduct activities through 1 or a combination of these 3 mechanisms.

The ATP licence

Applicants should review the guidance document relevant to their advanced therapeutic product before they apply for an ATP licence. They may need to contact us before they submit their application.

Once they complete and submit their application, we will review it.

We may issue or amend an ATP licence if the applicant has provided sufficient evidence to show that the:

• benefits outweigh the risks and
• risks and the activity are adequately managed and controlled

Organizations that hold an ATP licence may be subject to terms and conditions imposed on the licence.

Terms and conditions are based on information available to us on the product's benefits and risks. If we receive new information after issuing an ATP licence, we may:

• amend existing terms and conditions
• impose new terms and conditions

The order of permission

We may issue an order of permission to any person within a class of persons that is specified in the order. Examples of a class of persons are hospitals, pharmacists and physicians.

This order would permit the person within the class to conduct an activity or activities, as long as they comply with any terms and conditions that may be imposed.

Fees

Fees for therapeutic products and establishments are fixed, in accordance with the Fees in Respect of Drugs and Medical Devices Order.

We may determine that fees are appropriate for the regulated activities related to a tailored ATP pathway. Costing will be conducted in a transparent manner and stakeholders will be consulted.

Monitoring ATPs

As with other therapeutic products, stakeholders will be responsible for monitoring their advanced therapeutic products.

Organizations that hold an ATP licence and persons subject to an order of permission must:

• understand their obligations under the act
• comply with the tailored requirements for ATPs and all terms and conditions
• monitor the safety, effectiveness and quality of their unique product over its lifecycle and
• take steps to respond to changes in a product's safety, effectiveness and quality to ensure the benefits continue to outweigh the risks

Health Canada:

• monitors the safety and effectiveness of an advanced therapeutic products over its lifecycle
• applies the act and associated regulations to monitor and mitigate safety signals
• introduces legislative and regulatory obligations to mitigate any emerging safety signals and
• undertakes compliance and enforcement action when necessary

The nature of post-market surveillance for ATPs will depend on what is known about the product:

• when it's approved for the Canadian market and
• over the course of its lifecycle

Appropriate post-licensing vigilance measures could be decided on accordingly. Measures could include, for example:

• collecting safety information
• detecting, analyzing and reporting safety issues that may impact the authorization decision
• reporting real-world safety and usage data
• taking other vigilance or risk mitigation activities using instruments such as:
  • registries
  • safety studies
  • risk management plans

Those who do not comply with the tailored pathway requirements or with terms and conditions would be subject to compliance and enforcement actions by us.

Learn more:

• Compliance and enforcement policy framework
• Compliance and enforcement policy for health products (POL-0001)

To protect the health and safety of people in Canada, we could take a number of actions, such as:

• suspend or revoke an ATP licence, in whole or in part
• amend or repeal an order of permission

Reasons for suspending or revoking an ATP licence may include concerns about the:

• safety, effectiveness or quality of the product
• holder or person in a class not complying with terms and conditions

We may suspend an ATP licence without notice if an immediate suspension is necessary to prevent harm to people. Before doing so, we would consider the nature and severity of the harm and how likely it is to occur or reoccur.

In most cases, we would suspend an ATP licence, rather than immediately revoke it.

Once an ATP licence is suspended or revoked, the licence holder cannot conduct the specified activities set out in the licence.

Closing a tailored ATP pathway

A tailored ATP pathway can be used for several years. We need time to:

• test and adjust the tailored requirements and
• change regulations

When we have gathered enough information about how to regulate the ATP, we will either:

• incorporate the tailored requirements into existing regulations or
• create new regulations under the act

Any permanent regulatory changes as a result of this ATP tailored pathway are subject to the requirements set out in the Cabinet directive on regulation. Such changes include publishing proposals for consultation in the Canada Gazette.