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Clinical Trial Regulatory Activities in eCTD

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

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

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...

Canadian Product Monograph– Upcoming changes & Implementation Timeline

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

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

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

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

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

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

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

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

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...