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Health Canada Notice: Management of clinical trials during COVID-19
Author: Preetha Prabhu On Apr. 22, 2020, Health Canada published a notice to clinical trial sponsors regarding management of clinical trials during the COVID-19 pandemic....
The Ever-Changing Hard Surface Disinfectant Landscape in COVID-19 times
Author: Teri Dickinson , Manager, Regulatory Affairs, Dell Tech Laboratories Ltd. These days, the world of hard surface disinfectants and pathway to registration changes...
Regulatory Enrolment Process: Mandatory effective October 1, 2020
Author: Preetha Prabhu On Mar. 30, 2020, Health Canada published a notice that as of October 1, 2020 use of the Regulatory Enrolment Process (REP) will be mandatory for...
Health Canada’s Interim Expedited Licensing Approach for the Production and Distribution of Alcohol-Based Hand Sanitizers
Author: Joe McCarthy , Dell Tech Laboratories Ltd. To facilitate the safe and efficient production of Natural Health Product (NHP) hand sanitizers during the COVID-19...
PAAB: Update on Digitization of Advertising / Promotional Systems (APS)
Author: Preetha Prabhu In the light of evolving COVID-19, some manufacturers are modifying how their drug representatives interact with healthcare professionals. PAAB has...
Clinical Trial Regulatory Activities in eCTD
Author: Preetha Prabhu On February 19, 2020, Health Canada announced that the pilot for Clinical Trial regulatory activities in electronic Common Technical Document (eCTD)...
Information on Nitrosamine Impurity
Author : Preetha Prabhu In July 2018 Health Canada first became aware of the presence of nitrosamine impurity, N-nitrosodimethylamine (NDMA) in certain “sartan” angiotensin...
The Emerging Viral Pathogen 2019-nCoV (Coronavirus) and what it means for Broad Spectrum Virucide Disinfectants
Author: Teri Dickinson , Manager, Regulatory Affairs, Dell Tech Laboratories Ltd. On January 30, 2020 the World Health Organization (WHO) declared 2019-nCoV, as belonging to...
Canadian Product Monograph– Upcoming changes & Implementation Timeline
Author: Preetha Prabhu Health Canada is committed towards improving the accessibility and quality of drug product information for Canadians by making it more relevant and...
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 and...
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 1,...
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 new...
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 on a...
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”. In...
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 Canadians...
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...
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 traditionally...
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...