1. PAAB’s Accelerated Review Options -
In July 2022, the Pharmaceutical Advertising Advisory Board (PAAB) will launch four Accelerated Review Options (ARO) to its standard pre-clearance pathway, covering a range of...more
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
UPDATE: The Interim Order No. 2 respecting clinical trials for medical devices and drugs relating to COVID-19: Notice was made on May 3, 2021 (see Notice here) and repeals the Interim Order respecting clinical trials for...more
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