Welcome to the CAPRA Blog
Health Canada’s Scanning and Consultations on What’s Next for Health Product Regulation
By: Pinky Mazumder With the rapid evolution of healthcare technologies, Health Canada undertook a scanning exercise to identify key drivers involved in shaping the future of...
Health Canada Getting Tougher on Opioid and Illegal Advertising
Author: John Wong, Director, Regulatory Drug Advertising & Promotion, TPIReg/Inomar Strategies In light of the on-going and escalating opioid crisis, the Federal Health...
Guidance Document Regarding Administrative Processing of Submissions and Applications: Human or Disinfectant Drugs
Author: Bhavesh Patel, C. Chem. Health Canada recently published a guidance document to clarify the requirements for eligible drug submissions and applications processed...
Release of Draft Guidance Document: Regulatory Requirements for Drug Identification Numbers (DINs)
Author: Karen Zhou Health Canada recently released a draft guidance on regulatory requirements for Drug Identification Numbers (DINs). The intent of the document is to...
Health Canada Notice on the Discontinuation of Acknowledgement Letters for Regulatory Activities
Author: Pinky Mazumder On January 30, 2019, Health Canada published a Notice announcing a proposal to discontinue acknowledgement letters (Acknowledgement of Information...
Canadian Cannabis Survey 2018
Health Canada has been actively collecting data to better understand how Canadians view and use cannabis. Collection of detailed information on cannabis use has...
Health Canada Assessment Suggests that Talc May be Harmful to Human Health
Author: Pinky Mazumder In late 2018, Health Canada and Environment and Climate Change Canada announced the completion of the draft screening assessment of talc. Talc...
Health Canada Requests Feedback on Potential Impacts and Uses if Company Names were added to the Generic Submissions Under Review List
Author: Bhavesh Patel, C. Chem. Health Canada has recently requested feedback on a Phase III premarket transparency initiative to include the name of the sponsor on the list...
Improving Safety, Effectiveness and Quality – The Medical Device Action Plan
Author: Karen Zhou In a sweeping move to strengthen the safety, effectiveness and quality of medical devices, Health Canada has rolled out a three part Medical Device Action...
Summary of Annual Trends of Adverse Reaction Case Reports submitted to Health Canada
Author: Pinky Mazumder With the purpose of protecting the health of Canadians and monitoring the safety of products on the market, Health Canada collects reports of health...
Post-NOC Level III Change Updates
Author: Karen Zhou A post-NOC change is any change made to a new drug that has received a notice of compliance (NOC) pursuant to C.08.004 of the Food and Drug Regulations. ...
Cybersecurity – Draft Guidance Document
Author: Karen Zhou Medical devices play a pivotal and ever increasing role in improving access to care for patients. Through data exchange with network environments, medical...
Proposed Amendments to Regulations under the Ontario Drug Benefit Act and the Drug Interchangeability and Dispensing Fee Act
Author: Bhavesh Patel, C. Chem. Natco Pharma (Canada) Inc. The Ministry of Health & Long-Term Care recently announced proposed amendments to the regulatory scheme...
Software as Medical Devices (SaMD) – Where to go from here?
Author: Karen Zhou In an era of mobile apps on smartphones and tablets, Canada’s current software regulatory framework is long overdue for revision. Because the healthcare...
Device Advice: Health Canada Launching a New Pilot Project to Formalize Regulatory Advice Framework for Medical Device Manufacturers
Author: Bhavesh Patel, C. Chem. Health Canada recently announced it is the process of formalizing a meeting framework called "Device Advice: Pre-Clinical Meetings", where...
Health Canada Update on Investigational Testing Authorizations for Medical Devices
Author: Pinky Mazumder Investigational Testing Authorization (ITA) issued by Health Canada, allows for the testing of Class II, III, and IV medical devices with human...
Toward Global Harmonization - Health Canada to Adopt IMDRF Table of Contents Format for Class III and IV Applications
Author: Karen Zhou In another move toward global harmonization, by April 1, 2019, medical device manufacturers will be required to submit premarket applications for Class...
The Long-Awaited Legalization of Cannabis in Canada
Author: Pinky Mazumder On October 17th, 2018, the long-awaited legalization of cannabis will come into effect. Cannabis will no longer be subject to the Controlled...
Upcoming Guidance Development on the Licensing Requirements for 3D-Printed Devices
Author: Bhavesh Patel, C. Chem. Natco Pharma (Canada) Inc. Health Canada recently announced the development of a draft guidance document to assist medical device...
Certificate of Supplementary Protection (CSP) – Updated Guidance
Author: Karen Zhou Health Canada recently announced an update to Guidance Document: Certificate of Supplementary Protection Regulations . The purpose of the guidance is to...
Health Canada: Plan to Phase out Most Uses of Clothianidin and Thiamethoxam
Author: Bhavesh Patel Neonicotinoids are a class of pesticides used to control insects on a variety of agricultural crops, including seed treatments, and on turf and...
Vanessa’s Law – Taking a First Look
Author: Karen Zhou Vanessa’s Law (Protecting Canadians from Unsafe Drugs Act ), first enacted in 2014, added section 21.1(3) to Canada’s Food and Drugs Act to permit the...
Guidance on Notifying Health Canada of Foreign Actions
Author: Pinky Mazumder The guidance document on Notifying Health Canada of Foreign Actions (the “Guidance Document”) is intended to help Market Authorization Holders...
Strengthening Post-market Surveillance and Risk Management of Medical Devices in Canada
Author: Bhavesh Patel, C. Chem. Health Canada recently informed stakeholders, in particular manufacturers and importers of medical devices, of its intent to propose...
Health Canada: Transition to Global Medical Device Nomenclature
Author: Karen Zhou Health Canada has announced that it is initiating the transition to the Global Medical Device Nomenclature (GMDN) as a medical device categorization...