Health Canada

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December 11, 20201

What you need to know about the Pfizer-BioNTech Vaccine

Health Canada has authorized the first COVID-19 vaccine – a tremendous milestone for Canadians. Canada is the third country to approve the Pfizer-BioNTech vaccine, after the UK and Bahrain. This vaccine is an mRNA vaccine intended for use in people 16 years of age or older. It will be given..... Read More
Pharmaceutical Companies are using Artificial Intelligence to support their Pharmacovigilence Systems
August 27, 20191

Pharmaceutical Companies are using Artificial Intelligence to support their Pharmacovigilance Systems

Adverse drug reactions (ADRs) refer to unwanted or harmful reactions experienced following the administration of a medication. In Canada alone, the Adverse Drug Reaction Institute has estimated that there are approximately 200,000 severe ADRs each year, though it is believed that 95% of ADRs are not reported to drug manufactures..... Read More
What is Pharmacovigilance?
July 28, 20191

What is Pharmacovigilance?

Pharmacovigilance (PV) is defined by the World Health Organization (WHO) as ‘the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem’. It provides the foundation for monitoring and evaluating adverse drug reactions (ADRs) and is a key component of effective..... Read More
Active Pharmaceutical Ingredient API Registration in Canada
September 30, 20161

Active Pharmaceutical Ingredient (API) Registration in Canada

An active pharmaceutical ingredient (API) is an active ingredient or raw material used in the fabrication of a pharmaceutical drug dosage form. API quality directly impacts the safety and efficacy of the finished pharmaceutical dosage form. Poorly manufactured and contaminated active ingredients have been associated with negative health outcomes, including..... Read More
Regulatory Strategy
June 30, 2016Like

Natural Health Products (NHPs) and Regulatory Strategy

Natural health products (NHPs) include any substance or combination of substances including plants, plant materials, algae, bacteria, fungi, non-human animal material, their extracts, isolates, synthetic duplicates, vitamins, amino acids, essential fatty acids and their synthetic duplicates or minerals and probiotics that are either to diagnose, treat, mitigate a disease, disorder,..... Read More
drug regulatory requirements in canada
April 30, 20161

Drug Regulatory Requirements for Canada

Navigating through Canadian Drug Regulatory Processes AXSource Consulting Inc. helps its client manufacturers navigate through all the hurdles in the drug regulatory process. These usually include initial product classification, coordinating with Health Canada and consulting with drug manufacturers for successful market authorization, management of Health Canada regulatory filings for pre-market..... Read More