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 don't 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 complex and distinct.

We're establishing a new framework for ATPs based on new provisions in the Food and Drugs Act from June 2019. This framework will let us authorize ATPs in a flexible and risk-based manner. For more details, visit Advanced therapeutic products.

Innovators and industry will need guidance to navigate the new pathway. To serve this need, we plan to offer a specialized "concierge service." Users will have a 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 are committed to this initiative and will engage with stakeholders to help develop our approach.

Upcoming opportunities for comment

Underlying policy and operational work to implement this new framework is underway. This includes identifying the first ATP pathway.

For more project details and opportunities for comment, visit Advanced therapeutic products.

Contact us

Celia Lourenco
Director General
Biologic and Radiopharmaceutical Drugs Directorate
Health Products and Food Branch

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