Welcome to the CAPRA Blog
Software as a Medical Device (SaMD): Definition and Classification
Author: Teri Dickinson , Manager, Regulatory Affairs, Dell Tech Laboratories Ltd. The Medical Devices Regulations have been established under the authority of the Food...
Cost Recovery - Fees in Respect of Drugs and Medical Devices
Author: Teri Dickinson , Manager, Regulatory Affairs, Dell Tech Laboratories Ltd. After two years of extensive engagement, new fees and policies will come into force April...
Health Canada collaborates with U.S. and Australian regulators through Project Orbis: A framework for concurrent review of oncology products
Author: Preetha Prabhu On Dec. 6, 2019, Health Canada issued a News Release titled “International collaboration among Canadian, U.S. and Australian regulators leads to...
Changes to the Cosmetic Ingredient Hotlist
Author: Teri Dickinson, Manager, Regulatory Affairs, Dell Tech Laboratories Ltd. The Cosmetic Ingredient Hotlist is an administrative tool that Health Canada uses to...
Biosimilar Pharmaceuticals in Canada: Fact Sheet
Author: Bhavesh Patel This past August, Health Canada published a document titled “Biosimilar Biologic Drugs in Canada: Fact Sheet” to provide a comprehensive overview...
Health Canada Issues Important Safety Information for Ranitidine Products
By: Pinky Mazumder On September 13, 2019 Health Canada issued an Important Safety Information to the general public titled “Health Canada assessing NDMA in ranitidine”....
Regulatory Enrolment Process (REP) Pilot for Clinical Trials
Author: Bhavesh Patel Health Canada intends to launch a pilot project for clinical trial regulatory activities on November 1, 2019. The pilot project will be called the...
Health Canada: Drug and Medical Device Highlights 2018
Author: Bhavesh Patel Health Canada published the report on drugs for human use, medical devices and drugs for veterinary use. The report sets out new drugs and medical...
Health Canada Notice on ICH Q3D (R1) the Guideline for Elemental Impurities
By: Pinky Mazumder On May 31st, 2019, Health Canada issued a Notice titled the Release of the Finalised Guideline for ICH Q3D (R1): Guideline for Elemental Impurities and...
Special Access Program - Draft Guidance
Author: Karen Zhou The Food and Drug Regulations (“FDR”) contains emergency provisions (Part C, Division 8, sections C.08.010 and C.08.011 of the FDR) to provide...
Improving Access to Clinical Data
Author: Karen Zhou Health Canada has published final regulations that allow for the public release of clinical data on drugs and medical devices. Typically, clinical...
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...