A framework for regulating and authorizing advanced therapeutic products
On this page
- Why we need this framework
- How the framework works
- International harmonization
- Support for innovators
Why we need this framework
Most therapeutic products are regulated using existing rules under the Food and Drugs Act (act) and its regulations. However, these regulations do not adequately address the unique characteristics of some complex and distinct therapeutic products. We call these advanced therapeutic products (ATPs).
In 2019, the act was amended to address the regulation of ATPs.
The amendments made it possible to use a flexible and risk-based approach to regulate products that face a significant regulatory barrier. We can:
- establish tailored requirements to authorize an ATP with the ability to apply terms and conditions to each product authorization
- amend the product authorization requirements and any terms and conditions from time to time as new information and experience are gained
The ATP framework provides a way to test regulatory requirements and the oversight of therapeutic products before making changes to regulations. As more becomes known about a specific ATP, longer-term regulatory requirements may be established, as appropriate, to set standard rules for a product type.
How the framework works
We first consult stakeholders to understand the challenges. Next, we develop tailored requirements based on the unique characteristics of each type of therapeutic product (called an ATP candidate). Last, we add a description of the ATP to Schedule G of the act (the Minister has the final decision on whether to add this).
Learn more about how to get involved.
To sell, import or manufacture an ATP, persons can meet the tailored requirements and obtain an authorization. There are 2 ways to obtain an authorization:
- Through an application to Health Canada
- If necessary, we may apply terms and conditions to the ATP licence to manage risks or uncertainties or to mitigate harms.
- Through an order of permission made by the Minister
- An order could be given as a general permission instead of an ATP licence. Individuals or organizations subject to an order would still need to meet certain requirements.
In addition, all ATPs are subject to compliance and enforcement powers under the act.
Once we have determined the appropriate requirements, we either:
- create new regulations or
- amend existing regulations
International harmonization
It's important to harmonize Canadian requirements with those of international regulators and other key jurisdictions where appropriate. Harmonization helps to reduce barriers to entry in Canada.
We will consider best practices and how other jurisdictions have addressed the oversight of specific ATPs when we develop tailored requirements.
Support for innovators
Health Canada provides access to world-class regulatory knowledge, expertise and experience to organizations of all backgrounds and sizes. We provide support in various ways, such as by:
- coordinating pre-submission or pre-application meetings
- giving advice on the classification of therapeutic products
- giving advice on the appropriate regulatory pathway
Through our Office of Advanced Therapeutic Products, we provide additional support to stakeholders to help navigate the ATP process.
Send us an email at atp-ptn@hc-sc.gc.ca.
Related links
Page details
- Date modified: