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Draft guidance on advanced therapeutic products framework: Developing tailored requirements, Schedule G

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Collaborative and iterative approach

Once we select an ATP candidate to proceed to the next step, we engage key critical partners to help us develop the tailored requirements. This process is transparent and involves engaging early and often with interested and affected parties.

Partners may include the following:

During the engagement process, we will consider the needs of the health care system as a whole.

Health Canada convenes and consults affected and interested parties through meetings, workshops, emails and other methods, which are determined on a case-by-case basis. For example, if we establish a reference group, it will consist of both technical experts and interested stakeholders. We will consult the group as often as needed to cover various topics related to the specific ATP candidate.

All stakeholders will learn together about the regulatory barriers and discuss approaches.

These consultations are opportunities to discuss and provide evidence-based insight and real time advice on potential solutions to address regulatory barriers. They also help to inform the development of the ATP-specific guidance document.

Public consultation on notice of intent and draft guidance

Health Canada will:

A notice of intent will be published in Canada Gazette, Part I. The draft ATP-specific guidance document on the new, anticipated tailored requirements will be published separately for public consultation.

Publication of ministerial order and final guidance

When a therapeutic product or class of therapeutic products is added to Schedule G of the act, Health Canada develops a ministerial order to add the ATP. The ministerial order and an accompanying statement are published in Canada Gazette, Part II. This statement:

At this time, we will also publish the ATP-specific guidance document that was finalized as a result of the public consultation. This document will set out the information referred to in subsection 21.92(2) of the act that will likely need to be provided in an ATP licence application filed by an applicant. This information will be required to enable the Minister to exercise discretion under subsection 21.92(1) of the act to decide whether to issue or amend a licence. These decisions on the final tailored requirements will be taken case-by-case for each ATP licence applicant.

The ATP-specific guidance document will also specify the form and manner that the application must be filed. If the Minister makes an order under section 21.95 of the act, the guidance document will also include information related to the order of permission.

Authorization of activities related to ATPs

After the Minister has added a description of an ATP or class of ATPs to Schedule G, the following activities are prohibited pursuant to section 21.9(1) of the act, unless the person is authorized to conduct the activity:

The prohibition applies, regardless of whether the activity conducted is for the purpose of sale or use of the ATP.

A person may be authorized to conduct the otherwise prohibited ATP activity by:

  1. holding an ATP licence
  2. being authorized under a section 21.95 ministerial order
    • also known as an order of permission
  3. conducting the otherwise prohibited activity in accordance with the respective regulations under the act
    • despite the listing on Schedule G, a person could still gain authorization for any of the prohibited activities through the schemes available in regulation, if and where possible

A person may be authorized to conduct activities in relation to an ATP through a combination of these 3 mechanisms.

Health Canada could decide to authorize some activities using the ATP framework, but other activities could be subject to other regulations under the act.

Once an ATP is described on Schedule G of the act, the tailored ATP pathway becomes an additional, optional pathway to authorize activities. The ATP framework is designed to give Health Canada the greatest possible flexibility when providing regulatory oversight of ATPs.

Application and issuance of an ATP licence

You need to submit an application to Health Canada to obtain a licence.

The ATP-specific guidance document will contain the application form, as well as information on such items as the management of applications, fees and performance standards.

An ATP licence may be issued or amended according to subsection 21.92(1) of the act if the applicant has provided sufficient evidence to support the conclusion that:

Once issued, the holder of the ATP licence may be subject to terms and conditions imposed on the licence. These could include, for example, requirements relating to clinical information, quality information, labelling and risk management plans.

Health Canada will monitor the compliance of ATP licence holders with the act and may undertake compliance and enforcement action when necessary. Post-market oversight (terms and conditions imposed and compliance monitoring) will be in keeping with the risk presented by the ATP product and tailored to fit specific product requirements.

We may refuse to issue or amend an ATP licence if the application is found to be incomplete or non-compliant with the requirements outlined in the act.

Terms and conditions imposed on an ATP licence

Terms and conditions are a regulatory tool that enables oversight of therapeutic products throughout their life cycle. They are used to manage and control risks associated with the ATP and the activity and to gather information on the product's safety, efficacy and quality.

Pursuant to subsection 21.92(3) of the act, Health Canada may impose terms and conditions on an ATP licence when we issue the licence. We do so based on information available to us on the product's benefits and risks.

We may also amend existing terms and conditions and impose new terms and conditions at any time after we issue the ATP licence if we receive new information.

Before imposing or amending a term or a condition on a licence, we will consider whether it may help to:

We will also consider whether the term(s) or condition(s) that may be imposed on a licence:

Terms and conditions will be imposed on a licence in a fair manner that allows the licence applicant an opportunity to be heard. Health Canada will aim to ensure that the:

ATP licence holders must comply with all terms and conditions listed on their ATP licence in the allotted time stated. Failure to comply with the terms and conditions is a contravention of section 21.7 of the act and an offence under section 31.2.

ATP licence holders who do not comply with the terms and conditions will be subject to compliance and enforcement actions.

Suspension and revocation of an ATP licence

The Minister may suspend or revoke an ATP licence, in whole or in part, if:

Reasons for a suspension or revocation may include concerns related to:

If we believe there are grounds to propose a partial or full suspension of an ATP licence (subsection 21.93(1) of the act), we will notify the licence holder in writing. We will give the reason for and the proposed date of the suspension. The licence holder will be given an opportunity to be heard.

The written notification will set out the steps and timeline for any corrective action, should it be required.

If we determine that the grounds to propose the suspension did not exist or have been corrected, we will not suspend the licence.

An ATP licence may be suspended without prior notice (subsection 21.93(2) of the act) if an immediate suspension is necessary to prevent injury to health. When deciding whether to suspend without notice, we consider the nature and severity of the injury and the probability of it occurring or re-occurring.

In this case, we give the licence holder an opportunity to make representations about the suspension as soon as it is reasonable to do so.

If we determine that the grounds for suspension did not exist or have been corrected, we will reinstate the licence.

In most cases, Health Canada will exercise the suspension power before revoking an ATP licence. An ATP licence may be partially or totally revoked (subsection 21.93(1) of the act) if it has not been demonstrated that the situation did not exist or has been corrected.

When an ATP licence is suspended or revoked, the authorization holder must stop all specified activities.

Making of an order

Health Canada may make an order (subsection 21.95(1) of the act) authorizing any person within a class of persons that is specified in the order to perform 1 or more of the following activities:

We may include terms and conditions in an order when it is published.

An order of permission is a general rule of application that allows a class of persons to conduct an activity provided that certain terms and conditions, if any, are met. A person in the class of persons authorized in the order may perform the activity(ies) related to the ATP as soon as the order is in force. However, they must first meet the terms and conditions.

Individual licences are not issued in the case of an order of permission.

Licensing offers a more targeted means of oversight and control over an activity compared to relying on terms and conditions in an order of permission. As licensing can represent a burden on both the affected party and Health Canada, the making of an order may be a more appropriate way to regulate the ATP activities in these instances.

We may indicate in the order of permission that certain provisions of other Food and Drugs Act regulations continue to apply to the authorized classes of persons.

Persons subject to an order of permission must comply with all of its terms and conditions, if any, pursuant to subsection 21.95(3) of the act. Failure to comply with the terms and conditions contravenes this section of the act and is an offence under section 31.2.

Persons who do not comply with the terms and conditions will be subject to compliance and enforcement actions.

Fees

Generally, fees for drug and medical device products and establishments are fixed.

We will consult interested and affected parties to develop the fees for each specific ATP if we determine that fees are appropriate for regulated activities related to a tailored ATP pathway.

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