Improving the regulatory review of drugs and devices

From: Health Canada

Health Canada is collaborating with our international partners on issues related to drug and medical device clinical trials, authorizations, risk assessments, and potential shortages. Learn about how we are engaging our international partners on COVID-19 health products issues.

Our health care system is changing rapidly. We need a regulatory system that adapts to changes in health care delivery while giving people faster access to the drugs and medical devices they need. We must also continue to make sure that all drugs and devices we approve are:

  • safe
  • effective
  • of good quality

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Working together with you

Please sign up to our Consultation and Stakeholder Information Management System (CSIMS) to stay engaged on any of our projects through:

  • meetings
  • webinars
  • publications
  • consultations
  • policy documents


To develop and implement this plan, consultations will take place between now and 2021.

Our plan

Our current regulatory system is in need of some improvements to:

  • make it more efficient
  • support timely access to therapeutic products and
  • build better linkages within the health care system as a whole

This plan includes providing more timely access to drugs and devices, including orphan drugs / drugs for rare diseases by:

  • expanding the priority review process, to decrease review time for products needed by the health care system, including drugs for rare diseases
  • renewing the Special Access Programme to improve access to products that are not now authorized for sale in Canada
  • improving access to generics, biosimilar drugs and biologics by ensuring more timely review of these products
  • building better access to digital health technologies (such as remote monitoring devices) and developing targeted review processes for these applications
  • formalizing a pre-clinical meeting framework where medical device manufacturers will be able to receive advice and recommendations especially on their investigational testing protocols  

We also plan to make better use of real-world evidence to support regulatory decisions across a product's life cycle for both drugs and medical devices. "Real-world evidence" is data collected outside the strictly controlled environment of clinical trials (for drugs) and investigational testing (for medical devices) once a product is marketed.

In addition, we will modernize our operations to:

  • release information so Canadians know more about the products Health Canada authorizes
  • update how much industry pays for a submission to be reviewed, so that tax payers will carry a lower cost for the regulatory review of products

We will consult broadly with stakeholders on our plan and the individual projects, including:

  • patient groups
  • health partners
  • industry

By 2021, we will implement a plan to work together more with our health partners at home and abroad, including:

  • health technology assessment organizations, to reduce the time between Health Canada approvals and reimbursement recommendations
  • international regulators, to explore the idea of joint reviews to increase efficiencies and expertise in the review process
  • international regulators, to make use of foreign decisions to support access to products otherwise not available in Canada

Orphan drugs / drugs for rare diseases

We understand the particular needs and challenges of Canadians with rare diseases and are committed to improving access to medications that treat these conditions. With this plan, we intend to increase the availability of drugs that meet the needs of the health care system, including drugs for rare diseases.

Learn more about how current regulations apply to drugs for rare diseases.


Reports and publications

As related reports and publications become available, we will post them here.

Related Information

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