Improving the regulatory review of drugs and devices
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
On this page
- Working together with you
- Consultations
- Our plan
- Orphan drugs / drugs for rare diseases
- Projects
- Reports and publications
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
Consultations
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.
Projects
- Aligned reviews for certain drugs
- Early scientific advice to manufacturers
- Use of foreign reviews and decisions
- Worksharing with other international regulatory authorities
- Expanding priority review pathways for drugs that meet health care system needs
- Improving access to biosimilars and biologics
- Improving access to generic drugs
- Building better access to digital health technologies
- Device advice for medical devices
- Renewal of the Special Access Programme
- Strengthening the use of real world evidence for drugs
- Strengthening the use of real world evidence and regulations for medical devices
- Appropriate cost recovery framework
- Public release of clinical information
Reports and publications
As related reports and publications become available, we will post them here.
- Consultation – Draft Guidance for Foreign Risk Notification, Annual Summary Reports, and Issue-related Analysis of Safety and Effectiveness for Medical Devices [2019-09-18]
- Canada Gazette, Part 1, Volume 153, Number 24: Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Post-market Surveillance of Medical Devices) [2019-06-15]
- Canada Gazette, Part 1, Volume 153, Number 19: Regulations Amending Certain Regulations Made under the Food and Drugs Act (Sale of a New Drug for Emergency Treatment) [2019-05-11]
- Canada Gazette, Part 1, Volume 153, Number 19: Regulations Amending Certain Regulations Concerning the Sale of Drugs (Public or Canadian Armed Forces Health Emergencies) [2019-05-11]
- Consultation – Draft Guidance Document for Industry and Practitioners on the Special Access Program (SAP) for Drugs [2019-05-10]
- Consultation on the Draft Guidance: Public or Canadian Armed Forces Health Emergencies – Drugs for Immediate Use or Stockpiling [2019-05-10]
- Consultation on Draft Guidance: Accelerated Review of Human Drug Submissions [2019-05-07]
- Optimizing the Use of Real World Evidence to Inform Regulatory Decision-Making [2019-04-16]
- Notice of Intent: Transitioning Product Monographs to a Structured Format [2019-04-10]
- Health Canada approves new drug to treat metastatic breast cancer through international and domestic joint reviews [2019-04-09]
- Consultation of Draft Guidance Documents: Identifying and Labelling Medicinal Ingredients, Generic Drug Equivalence: Medicinal Ingredients [2019-04-08]
- Canada Gazette, Part 1, Volume 153, Number 13: Regulations Amending the Food and Drug Regulations (Improving Access to Generics [2019-03-30]
- Regulations Amending the Food and Drug Regulations (Public Release of Clinical Information: SOR/2019-62) [2019-03-20]
- Elements of Real World Data/Evidence Quality throughout the Prescription Drug Product Life cycle [2019-03-05]
- Notice to industry: Health Canada and CADTH launch new initiative to provide early parallel scientific advice [2019-02-28]
- Notice: Device Advice: Health Canada has launched an e-Learning tool to aid in understanding the premarket regulatory requirements for medical devices in Canada [2019-02-06]
- Notice: Australia Canada Singapore Switzerland (ACSS) Consortium - Approval of Erleada [2018-07-13]
- Notice to industry: Aligned reviews between Health Canada and health technology assessment organizations [2018-06-22]
- Possible Changes to the Food and Drug Regulations: Generic Drug Equivalence and Related Terminology [2018-06-11]
- Public Release of Clinical Information - Draft Guidance Document [2018-04-13]
- Notice of intent: Strengthening the post-market surveillance and risk management of medical devices in Canada [2018-04-10]
- Meeting Announcement - Scientific Advisory Committee on Digital Health Technologies (SAC-DHT) [2018-06-07]
- Notice : Medical Device Cybersecurity [2018-08-15]
- Consultation: Pre-market Requirements for Medical Device Cybersecurity [2018-12-07]
- Consultation Notice for Draft Guidance Document – Pre-market Requirements for Medical Device Cybersecurity [2018-12-07]
- Draft Guidance Document – Pre-market Requirements for Medical Device Cybersecurity [2018-12-07]
- Notice: Release of the Draft Guidance Document: Licensing Requirements for Implantable Medical Devices Manufactured by 3D Printing [2018-11-08]
- Draft Guidance Document: Licensing Requirements for Implantable Medical Devices Manufactured by 3D Printing [2018-10-08]
- Defining decision-grade real-world evidence and its role in the Canadian context: A design sprint - Summary report of a workshop (you can request a French translation from hc.opeda-bpead.sc@canada.ca, this external link is in English only) [October 21, 2018]
Related Information
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