Draft guidance on advanced therapeutic products framework: Adjusting and closing a tailored ATP pathway

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Adjusting tailored requirements

Health Canada will continue to collect information after an activity relating to an advanced therapeutic product (ATP) is authorized and being conducted.

We may require additional data for safety, efficacy, effectiveness or quality reasons, or if new requirements are necessary to identify, characterize or mitigate an emerging risk.

We will evaluate potential issues and take action when there are identified problems.

Transition considerations

By adding a therapeutic product or a class of therapeutic products to Schedule G of the Food and Drugs Act (act) Health Canada enables the use of a tailored ATP pathway.

By creating this temporary pathway, we can regulate these ATPs in a way that does not impede innovation, while protecting the health and safety of people in Canada.

When enough information is learned about the appropriate regulatory oversight for the ATP, we can:

Removal from Schedule G

Health Canada will remove the ATP from Schedule G if new regulations or amended regulations representing the appropriate level of oversight for a given ATP are implemented.

We will develop a ministerial order to amend Schedule G.

The order and an accompanying statement will be published in Canada Gazette, Part II,describing the order and rationale for removing the ATP from the schedule.

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