Regulatory innovation for health products: Enabling advanced therapeutic products

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Why we need a pathway for advanced therapeutic products

Scientific and technological advances are accelerating the pace of change in health care. This is leading to the development of a range of innovative health products that are:

We have well-established protocols for both pre- and post-market oversight of traditional drugs and devices. However, our existing regulatory frameworks do not adequately address the characteristics of these new products. This leads to barriers in bringing these products to market and limits Canadians' access to new, potentially life-changing treatments.

Our plan

Advanced therapeutic products (ATPs) are drugs or devices that our current regulations were not designed to handle because they're so novel, complex and distinct.

We're establishing a new pathway for ATPs based on new provisions in the Food and Drugs Act from June 2019. This pathway will let us authorize ATPs in a flexible and risk-based manner. This approach is also known as a "regulatory sandbox" and will only be used when:

Most drugs and devices will continue to be regulated under existing regulatory frameworks.

Establishing a sandbox allows us to tailor regulatory requirements for a specific product type. It addresses the product's unique characteristics while maintaining high standards for patient safety, product quality and efficacy.

Regulating products in a sandbox will require consultation with:

Early alignment and coordination with these groups will also be critical to support access and adoption.

Designing and tailoring regulatory requirements this way ensures that we can adapt our regulatory system to new and emerging innovations in drug and medical device development.

Innovators and industry will need guidance to navigate the new pathway. To serve this need, we plan to enhance client services with a specialized "concierge" service for the ATP pathway. The concierge will give users a single point of contact for direct, well-informed interactions with a Health Canada representative for ATP products.

Implications from COVID-19

The COVID-19 pandemic affected the timelines for implementation of the ATP pathway and concierge service. We remain committed to advancing this initiative and will engage with stakeholders to inform our approach.

Upcoming opportunities for comment

Engagement will resume in 2021, focusing on the design and implementation of the new ATP pathway and concierge service.

We anticipate completing the underlying policy and operational work to implement this new pathway by the end of 2021. This includes the identification of a pilot for the first regulatory sandbox.

Extensive consultation will be a part of any product being considered for this pathway.

Contact us

Celia Lourenco
Director General
Biologic and Radiopharmaceutical Drugs Directorate
Health Products and Food Branch
E-mail: hc.atp-ptn.sc@canada.ca

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