Promoting competition and innovation in Canada’s health sector, including the pharmaceutical industry, is a strategic priority for the Competition Bureau. In 2021, the Bureau announced that it joined its counterparts in the...more
As previously reported... on September 16, 2020, Canada’s Minister of Health approved an Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (the ISAD Interim Order), which...more
4/16/2021
/ Canada ,
Coronavirus/COVID-19 ,
Deadlines ,
Health Canada ,
Intellectual Property Protection ,
Manufacturers ,
Minister of Health ,
Patented Medicines ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Prescription Drugs ,
Vaccinations
On March 12, 2021, Health Canada released for consultation its new Draft Guidance Document on Electronic media in prescription drug labelling. The draft Guidance sets out Health Canada’s expectations for drug manufacturers...more
The Canadian Agency for Drugs and Technologies in Health (CADTH) published an interesting new report on January 29, 2021 about Health Technology Trends to Watch. The report identifies the following list of emerging trends...more
3/30/2021
/ 3D Printing ,
Artificial Intelligence ,
Augmented Reality ,
CADTH ,
Canada ,
Connected Items ,
Coronavirus/COVID-19 ,
Diagnostic Tests ,
Health Canada ,
Health Technology ,
Life Sciences ,
Medical Devices ,
Pain Management ,
Pharmaceutical Industry ,
Popular ,
Regenerative Medicine ,
Telehealth ,
Virtual Reality ,
Virus Testing
UPDATE: The Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) were published in the Canada Gazette on September 1, 2021. These amendments are intended to provide Health Canada with...more
12/18/2020
/ Advertising ,
Canada ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Food & Drug Regulations ,
Health Canada ,
Imports ,
Infectious Diseases ,
Interim Measures ,
Life Sciences ,
Medical Devices ,
New Guidance ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Amendments ,
Record Retention ,
Supply Chain ,
Supply Shortages ,
Vaccinations
On September 28, 2020, the Regulations Amending Certain Regulations Made under the Food and Drugs Act (Sale of a New Drug for Emergency Treatment) (Regulations) came into force. Health Canada subsequently published a Notice,...more
11/9/2020
/ Canada ,
Controlled Substances ,
Final Guidance ,
Food and Drug Act ,
Health Canada ,
Health Care Providers ,
Hospitals ,
Life Sciences ,
Manufacturers ,
New Regulations ,
Patented Medicine Prices Review Board (PMPRB) ,
Pharmaceutical Industry ,
Pharmacies ,
Physicians ,
Prescription Drugs
Health Canada has instituted numerous measures to help address and combat COVID-19, from facilitating access to COVID-19 products to protecting the public from false or misleading advertisements claiming to prevent, treat or...more
COVID-19 has resulted in the launch of numerous new products, as well as numerous new claims about existing products. Products can be classified as drugs (including natural health products and hard surface disinfectants) or...more
Health Canada has recognized for many years that the current regulatory regime on drug sampling, which significantly restricts the distribution of drug samples to both consumers and health care professionals, is outdated. For...more
6/9/2020
/ Amended Regulation ,
Health Canada ,
Health Care Providers ,
Manufacturers ,
Natural Products ,
New Guidance ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
Pharmacies ,
Physicians ,
Prescription Drugs
The federal government has been proactive in seeking help from industry in tackling the pandemic. For example, Health Canada contacted Health Product Licence Holders to let them know specific areas where they may be able to...more
5/18/2020
/ Canada ,
Clinical Trials ,
Health Canada ,
Medical Devices ,
Medical Research ,
Medical Supplies ,
Personal Protective Equipment ,
Regenerative Medicine ,
Research and Development ,
Supply Chain ,
Supply Shortages ,
Vaccinations
UPDATE: The Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 was made on March 1, 2021 and repeals and replaces the Interim Order Respecting Drugs, Medical...more
4/22/2020
/ Canada ,
Clinical Trials ,
Controlled Substances ,
Coronavirus/COVID-19 ,
Expedited Approval Process ,
Food and Drug Act ,
Guidance Documents ,
Health Canada ,
Medical Devices ,
Personal Protective Equipment ,
Pharmacies ,
Prescribing Authority ,
Prescription Drugs ,
Public Health Emergency ,
Relief Measures ,
Temporary Regulations ,
Transparency ,
Vaccinations ,
Virus Testing
UPDATE: The Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 was made on March 1, 2021 (see Notice here) and repeals the Interim Order Respecting the Importation and...more
4/9/2020
/ Canada ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Health Canada ,
Imports ,
Infectious Diseases ,
Interim Rule ,
Manufacturing Facilities ,
Medical Devices ,
Medical Research ,
Medical Supplies ,
Personal Protective Equipment ,
Pharmaceutical Industry ,
Public Health Emergency ,
Vaccinations ,
Virus Testing
Orders of prohibition relating to polymorphic form patent for PRISTIQ upheld on appeal -
As previously reported, the Federal Court, in a pair of decisions, granted orders prohibiting Apotex and Teva from marketing their...more
3/5/2019
/ Apotex ,
Appeals ,
Biologics ,
Canada ,
Costco ,
Damages ,
Dismissals ,
FDA Approval ,
Filing Deadlines ,
Fines ,
Generic Drugs ,
Health Canada ,
Health Insurance ,
Janssen Pharmaceuticals ,
Leave to Appeal ,
Marketing ,
Medical Devices ,
Minor Children ,
Mylan Pharmaceuticals ,
New Guidance ,
Novartis ,
Orders of Prohibition ,
Patent Applications ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Pharmacies ,
PMNOC Regulations ,
Post-Market Approval ,
Prescription Drug Coverage ,
Prescription Drugs ,
Rebates ,
Risk Assessment ,
Supreme Court of Canada ,
Teva Pharmaceuticals
The Canadian Federal government’s proposed amendments to the Cannabis Act and Regulations were published last month. Until February 20, 2019, Health Canada will be accepting comments on the proposed amendments, which set out...more
1/28/2019
/ Advertising ,
Beer ,
Caffeine Products ,
Canada ,
Cannabis Act ,
Decriminalization of Marijuana ,
Drug Approvals ,
Food and Drug Administration (FDA) ,
Health Canada ,
Labeling ,
Licensing Rules ,
Marijuana-Infused Edibles ,
Product Packaging ,
Proposed Amendments ,
Public Comment ,
Wine & Alcohol
In her report on the 2008 Canadian listeriosis outbreak, Independent Investigator Sheila Weatherill highlighted the need for “substantial consolidation and modernization” of the legislative and regulatory framework governing...more
8/2/2018
/ Agricultural Sector ,
Canada ,
Canadian Food Inspection Agency (CFIA) ,
Exports ,
Food and Drug Administration (FDA) ,
Food Borne Bacteria ,
Food Manufacturers ,
Food Safety ,
Food Supply ,
Foreign Suppliers ,
FSMA ,
Health Canada ,
Imports ,
Licensing Rules ,
New Regulations ,
Reasonable Prevention Procedures ,
Safe Food for Canadians ,
Verification Requirements
Health Canada News -
Health Canada issues updated guidance on PMNOC Regulations -
Health Canada has issued updated guidance reflecting the September 21, 2017 amendments: Guidance Document: Patented Medicines (Notice of...more
7/3/2018
/ Adverse Action Report ,
Biosimilars ,
Canada ,
Cannabis Act ,
Health Canada ,
Hospitals ,
Intellectual Property Protection ,
Medical Devices ,
Patent Litigation ,
Patented Medicines ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Proposed Regulation