Regulatory innovation for health products: Overview

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The need for regulatory innovation for health products

Health Canada is continuously looking ahead to understand the future drivers that will require us to adapt as a regulator. Our foresight efforts show that advances in science are resulting in more complex health products, such as:

  • gene editing
  • 3D bio-printing
  • continuously-learning, artificial intelligence applications

Health products are becoming increasingly personalized and precise, with the potential for delivery at a patient's bedside. Canadians are also:

  • demanding greater access to a wide range of health products
  • looking for more information to make decisions about their health

We need agile regulatory approaches to support access to these health technologies, while continuing to protect patient safety.

Groups such as the Health and Biosciences Economic Strategy Table have highlighted the need for greater agility and harmonization in our regulations to reduce barriers to innovation. This was reinforced during the 2018 Health and Biosciences Sector Regulatory Review consultations, where we engaged with hundreds of:

  • partners
  • innovators
  • patient groups
  • key stakeholders

The result of these consultations was the Health and Biosciences Sector Regulatory Review Roadmap. It outlined a number of commitments, including plans to modernize our regulations for:

  • clinical trials
  • drug and medical device licensing
  • advanced therapeutic products (ATPs)

We asked for feedback on these modernization efforts in a discussion paper. You can find more details about this consultation in our What We Heard report.

Implications from COVID-19

The COVID-19 pandemic created an unprecedented demand for health products and medical supplies to help manage and prevent the virus. In response, Health Canada introduced temporary measures to expedite the regulatory review of COVID-19 health products.

The pandemic has reinforced the need for regulatory agility to support timely access to needed health products without compromising:

  • safety
  • quality
  • efficacy

Our regulatory innovation agenda

The Regulatory Innovation Agenda aims to provide more regulatory flexibility to support innovative research and health product development. This will also help regulate the risks, benefits and uncertainties of more diverse and complex products.

There are 5 key pillars in our regulatory innovation agenda:

  1. Modernizing clinical trial regulations
  2. Enabling advanced therapeutic products
  3. Agile regulations for licensing drugs
  4. Agile regulations for licensing medical devices
  5. Information to Canadians mobile strategy

These pillars build on efforts to support timely access to health products through the regulatory review of drugs and devices initiative. While operational pressures from COVID-19 have affected the timelines for the agenda, we continue to be committed to advancing these goals.

Many parts of our vision for being a more agile regulator have helped our regulatory response to COVID-19.

These plans will also contribute to Canada's Biomanufacturing and Life Sciences Strategy. The strategy recognizes the importance of a best-in-class regulatory system that can enable the growth of the biomanufacturing and life sciences sector.

Moving forward, we will:

  • continue to engage with stakeholders and Canadians
  • build on lessons learned from the temporary agile measures in place for COVID-19
  • consult on all proposed policy and regulatory approaches as they are developed

Contact us

Ed Morgan
Director General
Policy, Planning and International Affairs Directorate
Health Products and Food Branch

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