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Step 2b draft Q3C(R8): Impurities: Guideline for Residual solvents – Released for public consultation

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

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...

Interim Order to facilitate COVID-19 Clinical Trials related to Drugs and Medical Device

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

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

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 drugs...

Health Canada Notice: Management of clinical trials during COVID-19

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...

The Ever-Changing Hard Surface Disinfectant Landscape in COVID-19 times

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

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

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)

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

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”...