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Regulatory innovation for health products: Overview

Overview

Modernizing clinical trial regulations

Enabling advanced therapeutic products

Agile licensing for drugs

Agile licensing for medical devices

Information to Canadians - mobile strategy

On this page

The need for regulatory innovation for health products

Implications from COVID-19

Our regulatory innovation agenda

Contact us

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:

Modernizing clinical trial regulations

Enabling advanced therapeutic products

Agile regulations for licensing drugs

Agile regulations for licensing medical devices

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

Email:

hpfb.engagement-mobilisation.dgpsa@hc-sc.gc.ca

Related links

Consultation on agile regulations for the licensing of drugs and medical devices

Health Canada's action plan on medical devices

What we heard report on the clinical trial regulatory modernization initiative

What we heard on agile regulations for advanced therapeutic products and clinical trials

Modernizing Canada's food regulations

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2022-12-16