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Step 2b draft Q3C(R8): Impurities: Guideline for Residual solvents – Released for public consultation
The ICH Q3C core guideline was finalized under Step 4 in July 1997, providing recommendations on the use of less toxic solvents in the manufacture of drug substances and...
An update from NNHPD – Release of new web PLA form version 4
Author: Bhavesh Patel Quick Facts about Natural Health Products in Canada: Health Canada regulates natural health products (NHPs) so that Canadians can have confidence that...
Interim Order to facilitate COVID-19 Clinical Trials related to Drugs and Medical Device
Author: Preetha Prabhu On May 23, 2020, the Minister of Health signed an Interim Order (IO) Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19....
Interim Labelling of products during COVID-19: Hand sanitizers, disinfectants, soaps and cleaning products
Author: Preetha Prabhu According to Statistics Canada, demand for hand sanitizer increased by 735% for the week ending March 14, 2020, relative to the same period last...
Distribution of low risk DIN/NPN products as samples
Author: Teri Dickinson , Manager, Regulatory Affairs, Dell Tech Laboratories Ltd. Beginning July 1, 2020 , industry will be able to distribute certain non-prescription...
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...
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...
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”...
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...
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...
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...