Effective novel and complex medicines are emerging.

As science and technology progresses towards increasingly complex and personalized medicines, regulators have recognized the need for a more agile approach to licensing and compliance. The current regulatory framework simply doesn’t work for a select group of very novel, very complex products.

Need an example?

Think of stem cell therapies that are developed at the point-of-care. Think of adaptive AI algorithms in software that update themselves automatically, using real-world data. Think of 3D-printers used to create medical devices such as surgical instruments or implants, at the point-of-care. Think of Chimeric Antigen Receptor (CAR) T-cells; created using a patient or donor’s immune cells and delivered at the point-of-care.

These products are very different from traditional pharmaceutical and medical device models for manufacturing, distribution, and use.

Health Canada’s ATP pathway.

This led to the decision to establish a new Advanced Therapeutic Products (ATP) Pathway. ATP products are defined as health products that are novel, complex and distinct in the ways they are developed, fabricated, and delivered to patients and consumers. In 2019, the Canadian Food and Drugs Act was updated to allow Health Canada to implement customized regulatory requirements to determine the appropriate oversight needed for innovative healthcare products.

Health Canada intends to pilot the new ATP pathway by March 2022 and will begin targeted stakeholder engagement this year. The objectives are to raise awareness of the new ATP pathway, obtain stakeholder feedback, and gain insight into potential ATP candidates. This work is critical to ensuring we can appropriately manage drugs and devices to assure the health and safety of consumers.

The ATP process will feature a ‘regulatory sandbox’ for Health Canada and stakeholders to determine the regulatory requirements for pre-market evidence and post-market surveillance of ATP product types. A Health Canada concierge service will also be introduced and will serve as a single point of contact for ATP products and enquiries.

A closer relationship with regulators.

From a licensing and compliance perspective, we’re looking at a more involved and iterative relationship with regulators. International regulatory authorities are working together to explore new ways to regulate these novel ‘misfit’ products. Determining the critical elements of safety, efficacy and compliance will require working closely with Subject Matter Experts (SMEs) in niche areas of science, technology, and healthcare. Using a ‘regulatory sandbox’ to allow stakeholders to try different methods and ideas for regulation will bring us closer to making innovative products more readily available for safe consumer use.

The AXSource perspective.

At AXSource, we believe regulatory and quality professionals will need a greater understanding of the science and technologies that underlie ATP products. As a recognized industry-leader in regulatory affairs and software and system validation, we are prepared to advise you on appropriate compliance measures for your organization’s needs.

Contact us today for support with your innovative products and technologies at info@axsource.com.