Drug and medical device 2017 accomplishments

Health Canada is recognized around the world as a highly respected regulatory authority.

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Agile and adaptive approval processes

The Canadian health care system is changing rapidly. We need to be able to adapt to changes in health care delivery while giving Canadians faster access to the drugs and medical devices they need.

We must continue to make sure that all drugs and medical devices we approve are of high quality and the benefits outweigh the risks.

In Budget 2017, the Government of Canada funded a series of projects to improve access to necessary prescription medications and medical devices.

Communicating the risks associated with opioids

Canada is facing a national opioid crisis. This is a complex health and social issue and we have committed to taking action.

Implementing regulations

Health Canada is responsible for implementing new regulations that give access to drugs that would help address an urgent public health need but are not yet authorized for sale in Canada. Drugs must have been approved in the United States, the European Union, or Switzerland.

Publishing draft regulations

We published draft regulations that would require risk management plans for opioids, and would require a patient information handout and warning sticker for all prescription opioids at the time of sale. The sticker and handout would better inform Canadian patients about the safe use of opioids and their associated risks.

Updating opioid labelling requirements

We are updating the labelling requirements for all prescription opioid drugs to add and clarify information that may help reduce risks to Canadians.

Reviewing drug submissions

We reviewed submissions for drugs, and combination drug/medical device products, indicated for the treatment of opioid use disorder and for safe pain management. Health Canada also wrote to industry to encourage them to pursue paths to market such products in Canada.

Better engagement: the patient voice

We could not do our work without help from the public, our partners, and stakeholders. Our stakeholders include the drug and medical device industries, and communities of medical and healthcare professionals. Patient and consumer voices are critical components in our work.

We met with patient and patient advisory groups throughout 2017 to get feedback and direction on our priorities. We will continue to seek out patient opinions, and incorporate them into our activities.

We use the Consultation and Stakeholder Information Management System (CSIMS) to share information on health topics and to invite people to take part in consultations.

We invite you to register as a member of an organization or as an individual, and participate more actively in our work.


Anticipating evolving health needs of Canadians

It is important for us to understand emerging health issues and new approaches that medical science has developed to secure health outcomes that respond to your needs.

Our goal is to identify and prioritize important and emerging health needs to ensure that future investments address the health challenges most likely to affect Canadians. We will identify high-impact health issues and undertake in-depth analysis to explore the implications for existing and new regulations and investment.

We are building networks to engage with stakeholders to inform and guide our work.

Planning for the future

Our planning initiative focuses on four key activities:


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