Health Canada#Branches

{{Distinguish||text=The Public Health Agency of Canada, the agency of the federal government responsible for public health}}

{{Infobox government agency

| agency_name = Health Canada

| type = Department

| seal =

| nativename = {{lang|fr|Santé Canada}}

| logo = Health Canada logo.gif

| jurisdiction = Canada

| headquarters = Ottawa, Ontario

| agency_type = Department responsible for federal health policy in Canada

| employees = 11,223 (March 2020){{Cite web|url=https://www.tbs-sct.gc.ca/ems-sgd/edb-bdd/index-eng.html#orgs/dept/127/infograph/people|title=GC InfoBase|website=www.tbs-sct.gc.ca|accessdate=Mar 5, 2021}}

| budget = $3.9 billion (2021–22){{Cite web|url=https://www.tbs-sct.gc.ca/ems-sgd/edb-bdd/index-eng.html#orgs/dept/127/infograph/financial|title=GC InfoBase|website=www.tbs-sct.gc.ca|accessdate=April 15, 2021}}

| minister1_name = Marjorie Michel

| minister1_pfo = Minister of Health

| minister2_name =

| minister2_pfo =

| deputyminister1_name = Greg Orencsak

| deputyminister1_pfo = Deputy Minister

| deputyminister2_name = Eric Costen

| deputyminister2_pfo = Associate Deputy Minister

| chief1_name =

| chief1_position =

| chief2_name =

| chief2_position =

| website = {{url|http://www.hc-sc.gc.ca/}}

}}

Health Canada (HC; {{langx|fr|Santé Canada, SC}})Health Canada is the applied title under the Federal Identity Program; the legal title is Department of Health ({{Langx|fr|Ministère de la Santé}}). is the department of the Government of Canada responsible for national health policy. The department itself is also responsible for numerous federal health-related agencies, including the Canadian Food Inspection Agency (CFIA) and the Public Health Agency of Canada (PHAC), among others. These organizations help to ensure compliance with federal law in a variety of healthcare, agricultural, and pharmaceutical activities. This responsibility also involves extensive collaboration with various other federal- and provincial-level organizations in order to ensure the safety of food, health, and pharmaceutical products—including the regulation of health research and pharmaceutical manufacturing/testing facilities.

The department is responsible to Parliament through the minister of health as part of the federal health portfolio."[https://www.canada.ca/en/health-canada.html Health Canada]". Canada.ca. Government of Canada (2025). Retrieved 15 March 2025. The deputy minister of health, the senior most civil servant within the department, is responsible for the day-to-day leadership and operations of the department and reports directly to the minister.

Originally created as the "Department of Health" in 1919—in the wake of the Spanish flu crisis{{Cite web |url=https://www.warmuseum.ca/firstworldwar/history/life-at-home-during-the-war/wartime-tragedies/influenza-1918-1919/ |title=Influenza, 1918-1919 {{!}} Canada and the First World War |date=2017 |orig-year=2008 |department=Canadian War Museum|publisher=Canadian Heritage |access-date=29 April 2020}}—what is known as Health Canada today was formed in 1993 from the former Health and Welfare Canada department (established in 1944), which split into two separate units; the other department being Human Resources and Labour Canada.{{Cite web|url=https://www.thecanadianencyclopedia.ca/en/article/health-canada|title=Health Canada|last=Cheung-gertler|first=Jasmin H.|date=2014|website=The Canadian Encyclopedia|publisher=Historica Canada|orig-year=2008|access-date=29 April 2020}}

Organization

Health Canada's leadership consists of:

Minister of Health
Deputy Minister
Associate Deputy Minister

= Branches =

The following branches, offices, and bureaus (and their respective services) fall under the jurisdiction of Health Canada:{{cite web|url=http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/index-eng.php|title=Health Canada's organizational structure|date=15 April 2020|website=Health Canada|publisher=Government of Canada|url-status=live|archive-url=https://web.archive.org/web/20101016061924/http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/index-eng.php|archive-date=2010-10-16|access-date=29 April 2020}}{{Tree list}}

Health Canada
Office of Audit and Evaluation
Departmental Audit Committee
Director General / Chief Audit Executive's Office
Internal Audit and Special Examinations
Program Evaluation Division
Performance Measurement Planning and Integration
Practice Management
Chief Financial Officer Branch
Departmental Performance Measurement and Evaluation Directorate
Departmental Resource Management Directorate
Financial Operations Directorate
Internal Control Division
Materiel and Assets Management Directorate
Planning and Corporate Management Practices Directorate
Communications and Public Affairs Branch
Ethics and Internal Ombudsman Services
Marketing and Communications Services Directorate
Planning and Operations Division
Public Affairs and Strategic Communications Directorate
Stakeholder Relations and Consultation Directorate
Controlled Substances and Cannabis Branch
Corporate Services Branch
Departmental Secretariat
Health Products and Food Branch
Assistant Deputy Minister's Office
Biologic and Radiopharmaceutical Drugs Directorate
Food Directorate
Marketed Health Products Directorate
Medical Devices Directorate
Natural and Non-prescription Health Products Directorate
Office of Nutrition Policy and Promotion
Policy, Planning and International Affairs Directorate
Resource Management and Operations Directorate
Therapeutic Products Directorate
Veterinary Drugs Directorate
Healthy Environments and Consumer Safety Branch
Consumer and Hazardous Products Safety Directorate
Environmental and Radiation Health Sciences Directorate
Policy Planning and Integration Directorate
Safe Environments Directorate
Climate Change and Innovation Bureau
Water and Air Quality Bureau
New Substances Assessment and Control Bureau
Existing Substances Risk Assessment Bureau
Legal Services
Opioid Response Team
Controlled Substances Directorate
Opioid Response Team Directorate
Pest Management Regulatory Agency
Regulatory Operations and Enforcement Branch
Strategic Policy Branch

=Partner agencies=

In their responsibility of maintaining and improving the health of Canadians, the Minister of Health is supported by the Health Portfolio, which comprises Health Canada as well as:{{cn|date=August 2023}}

Additionally, Health Canada is a corporate partner of the Canadian Association of Emergency Physicians (CAEP).{{Cite web |date=2019 |title=Annual Report 2018-2019 |url=https://caep.ca/wp-content/uploads/2019/06/Annual-Report2019-V2.pdf |url-status=live |archive-url=https://web.archive.org/web/20220420013556/https://caep.ca/wp-content/uploads/2019/06/Annual-Report2019-V2.pdf |archive-date=2022-04-20 |access-date=2022-06-18 |website=Canadian Association of Emergency Physicians}}

== International collaboration ==

In December 2016, Health Canada approved the purchase of a new botulism antitoxin called heptavalent botulism antitoxin (BAT) from the American-based company Emergent Biosolutions, a global specialty biopharmaceutical company. The PHAC has identified botulism as a likely biological terrorist threat.{{Cite news|url=https://finance.yahoo.com/news/emergent-biosolutions-receives-health-canada-120000674.html|title=Emergent BioSolutions Receives Health Canada Approval for Botulism Antitoxin|date=2016-12-12|work=Yahoo Finance|access-date=2017-01-11|url-status=live|archive-url=https://web.archive.org/web/20170113063320/https://finance.yahoo.com/news/emergent-biosolutions-receives-health-canada-120000674.html|archive-date=2017-01-13}}

Labs and offices

= Offices =

Office of the Cameron Visiting Chair
Office of the Chief Dental Officer
The National Office of WHMIS
Nurse Recruitment
Public Services Health Medical Centre

= Laboratories =

Laboratory Centre for Disease Control
Sir Frederick G Banting Research Centre

Compliance and Enforcement Directorate

The Compliance and Enforcement Directorate provides support to Health Canada by enforcing the laws and regulations pertaining to the production, distribution, importation, sale, and/or use of consumer products, including but not limited to: tobacco, pest control materials, drugs and medical devices, biologics, and natural health products.{{cn|date=August 2023}}

The Directorate conducts inspections and investigations to ensure that products are safe, of good quality, and properly labelled and distributed, in order to better protect Canadians from potentially harmful products and consumables.{{cn|date=August 2023}}

Compliance and Enforcement Directorate is divided into six distinct programs:{{cite web |url=http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/rapb-dgrp/reg/on-eng.php#a5 |title=About Health Canada - Ontario Region - Compliance and Enforcement |website=Health Canada |archive-url=https://web.archive.org/web/20131029200146/http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/rapb-dgrp/reg/on-eng.php |archive-date=2013-10-29}}

Canada Vigilance Program
Controlled Substances Program
Inspectorate Program
Pesticide Compliance Program
Product Safety Program
Tobacco Control Program

= Canada Vigilance Program =

Health Canada's Canada Vigilance Program (CVP) "collects and assesses reports of suspected adverse reactions to health products marketed in Canada," including prescription and over-the-counter medications, natural health products, biotechnology products, vaccines, blood products, human cell products, human tissue products, human organs, disinfectants and radiopharmaceuticals. The program has been in effect since 1965.{{Cite web |last=Health Canada |date=2022-06-15 |title=Canada Vigilance Program |url=https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/canada-vigilance-program.html |url-status=live |archive-url=https://archive.today/20230509195237/https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/canada-vigilance-program.html |archive-date=2023-05-09 |access-date=2023-06-19 |website=Government of Canada}}

Pharmacovigilance related to Adverse Events Following Immunization (AEFI) is a shared responsibility between Health Canada and the Public Health Agency of Canada.{{Cite web |last=Lamoureux |first=Kevin |date=2023-06-12 |title=Order Paper Question - Q-1448 |url=https://archive.org/details/order-paper-question-q-1448 |access-date= |website=Internet Archive |publisher=Government of Canada}}

Related legislation

Acts for which Health Canada has total or partial responsibility:{{cite web |url=http://www.hc-sc.gc.ca/ahc-asc/legislation/acts-lois/index_e.html |title=About Health Canada - Legislation & Guidelines - Acts |access-date=2007-04-15 |url-status=dead |archive-url=https://web.archive.org/web/20070519041022/http://www.hc-sc.gc.ca/ahc-asc/legislation/acts-lois/index_e.html |archive-date=2007-05-19 }}

Assisted Human Reproduction Act
Canada Health Act
Canadian Centre on Substance Abuse Act
Canadian Environmental Protection Act
Canadian Institutes of Health Research Act
Cannabis Act
Controlled Drugs and Substances Act
Comprehensive Nuclear Test-Ban Treaty Implementation Act
Department of Health Act
Financial Administration Act
Fitness and Amateur Sport Act
Food and Drugs Act
Hazardous Materials Information Review Act
Hazardous Products Act
Patent Act
Pest Control Products Act
Pesticide Residue Compensation Act
Quarantine Act
Radiation Emitting Devices Act
Tobacco Act & Act to Amend the Tobacco Act (sponsorship)

Acts which Health Canada is involved or has special interest in:

Broadcasting Act
Canada Labour Code
Canada Medical Act
Canada Shipping Act
Canadian Food Inspection Agency Act
Emergency Preparedness Act
Energy Supplies Emergency Act
Excise Tax Act
Federal-Provincial Fiscal Arrangements Act
Feeds Act
Immigration and Refugee Protection Act
National Parks Act
Nuclear Safety and Control Act
Non-Smokers Health Act
Queen Elizabeth II Canadian Research Fund Act
Trade Marks Act

Special access program

Health Canada has a special access program that health care providers may use to request medications that are not currently commercially available in Canada.{{cite web |last1=Canada |first1=Health |title=Health Canada's special access programs: Request a drug |url=https://www.canada.ca/en/health-canada/services/drugs-health-products/special-access/drugs.html |website=www.canada.ca |access-date=13 September 2021 |date=23 December 2002}}

COVID-19 response

{{anchor|Supriya Sharma}}The chief medical advisor of Health Canada, Supriya Sharma,{{cite news |last1=Rabson |first1=Mia |title='Unprecedented': How Canada approved five vaccines for COVID-19 in under a year |url=https://nationalpost.com/news/the-need-for-speed-how-canada-approved-five-vaccines-for-covid-19-in-under-a-year |access-date=28 April 2021 |work=The Canadian Press |publisher=The National Post |date=March 28, 2021}} as of April 2021, oversees the COVID-19 vaccine approval process in Canada.{{cite news |last1=Ritchot |first1=Mélanie |title=Nunavut to get 6,000 doses of Moderna vaccine in first shipment |url=https://nunatsiaq.com/stories/article/moderna-vaccine-approved-by-health-canada/ |agency=Nunavut News |publisher=Nortext Publishing Corporation (Iqaluit) |date=23 December 2020}}

In March 2021, the National Advisory Committee on Immunization made a declaration of a pause for the administration of the AstraZeneca vaccine to Canadians under the age of 55.{{cite news |last1=Cochrane |first1=David |last2=Tasker |first2=John Paul |title=Immunization committee to recommend provinces stop giving AstraZeneca vaccine to those under 55: sources |url=https://www.cbc.ca/news/politics/astrazeneca-under-55-1.5968128 |publisher=CBC |date=29 March 2021}}{{cite news |last1=Gillies |first1=Rob |title=Canada pauses AstraZeneca vaccine for under 55 |url=https://www.dailyherald.com/article/20210329/news/303299894 |agency=Associated Press |publisher=Chicago Daily Herald |date=29 March 2021}}

Criticisms

An editorial published by the Canadian Medical Association Journal has called for Health Canada to more strictly regulate natural health products. The editorial cited weaknesses in current legislation that allow natural health products to make baseless health claims, to neglect side-effects research prior to products reaching market, and to be sold without being evaluated by Health Canada.{{cite web|last=Gauntlet Editorial Board|title=Editorial: Mis-informed consent|url=http://thegauntlet.ca/story/15947|work=Editorial|publisher=The Gauntlet|access-date=18 December 2011|url-status=live|archive-url=https://web.archive.org/web/20120307040150/http://www.thegauntlet.ca/story/15947|archive-date=7 March 2012}}

On 10 September 2012, a report on CBC Television questioned the safety of drugs sold in North America.{{cite web|date=10 September 2012|url=https://www.cbc.ca/news/health/drug-safety-expert-questions-medications-made-overseas-1.1172550?corth|title=Drug safety expert questions medications made overseas|access-date=2012-09-11|url-status=live|archive-url=https://web.archive.org/web/20130329203552/http://www.cbc.ca/news/health/story/2012/09/10/drug-safety-china-india.html?corth|archive-date=2013-03-29}} The Canadian Press reported that Health Canada is secretive regarding inspections about drugs manufactured overseas, leaving the public unsure about the safety of these drugs.{{cite web|last=Bains|first=Camille|date=10 September 2012 |title=Health Canada mum on plant inspections: researcher|publisher=The Canadian Press|website=via BC - CTV News.ca |url=https://bc.ctvnews.ca/health-canada-mum-on-plant-inspections-researcher-1.949889|access-date=24 July 2022}}

Drug approvals process

Health Canada aims to provide responses to pharmaceutical innovators within 300 days of submitting a drug for review. However, for submissions filed between 2015 and 2019, only 33 percent received a response within that target. Fully 18 percent waited over a year, and almost 5 percent over two years. The average delay for a standard review was 335 days. Health Canada's accelerated pathway for approval dubbed "conditional compliance" reduces its target timeline to 200 days, but its actual average delay was still 302 days, and only 8 percent of applicants received responses within the 200-day target.{{Cite news|last=Post|first=Special to Financial|date=2021-06-16|title=Opinion: Let's have permanently quicker drug approvals|language=en|work=Financial Post|url=https://financialpost.com/opinion/opinion-lets-have-permanently-quicker-drug-approvals|access-date=2021-10-18}}

It has been suggested that government entities should make use of rolling submissions, as was done for COVID-19 vaccines, to proceed with the examination of partially complete submissions and accept new information as it becomes available, and also that drugs already approved in other jurisdictions should be approved more rapidly to avoid redundancy.