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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

What Health Canada Regulates: Health Products

How Health Canada engages with and informs Canadians

Information and privacy notice

Transparency of stakeholder communications for the regulatory review of drugs and devices

Page details

2025-02-28