Blog

dreamstime xxl 124729831 upside down man 3
June 17, 2021Like

Health Canada’s newest regulatory pathway is for products that don’t quite ‘fit’

Effective novel and complex medicines are emerging. As science and technology progresses towards increasingly complex and personalized medicines, regulators have recognized the need for a more agile approach to licensing and compliance. The current regulatory framework simply doesn’t work for a select group of very novel, very complex products. Need..... Read More
pharmacist and doctor study info about tablets 05272021
June 7, 20211

An update on the new Structured Product Monograph (SPM)

Product Monographs are used to provide information about the appropriate use of a drug to physicians, pharmacists, nurses, healthcare professionals, and consumers. Health Canada aims to harmonize the structure of Product Monographs and convert them into a structured format called Structured Product Monograph (SPM) as a part of a regulatory..... Read More
dreamstime xxl 202580320 women on couch telehealth
May 28, 20211

Tips on conducting clinical trials during the pandemic.

As always, ensure patient safety remains the top priority. The COVID-19 pandemic has impacted the health risks associated with running ongoing clinical trials. As a result, Sponsors must take the initiative to implement measures to reduce or prevent the risk of becoming infected with COVID-19. One should consider the availability..... Read More
Customer scanning product through cell phone 03302021 2
March 30, 20212

Did you know that Health Canada now requires Drug Labelling in SPM format?

Health Canada is adapting its systems with advances in science to maximize the safety of Canadians, and one of their initiatives is to improve drug product labels. The Agency recognizes that the publicly available labelling information should be transitioned from unstructured formats, like Portable Document Format (PDF), to an advanced..... Read More
iStock 000003420564Large chimp resized
March 19, 20211

So, what’s going on with the AstraZeneca vaccine?

After several reports on European countries suspending the use of the AstraZeneca COVID-19 vaccine, many Canadians are wondering if it is safe to use.   What you should know Law – Manufacturers in the pharmaceutical industry are required by law to report Adverse Drug Reactions (ADRs) to regulatory agencies such..... Read More
gavel
March 2, 20212

Health Canada issues a new Interim Order for COVID-19 products

At the start of the COVID-19 pandemic, Health Canada issued an interim policy to allow the import of products that do not fully meet regulatory requirements, but were comparable, to meet the incredibly high demand for disinfectants and hand sanitizers. This policy allowed the government to resolve 25 Tier 3..... Read More
Health Canada approved COVID-19 vaccines
February 26, 20212

How effective are Health Canada approved COVID-19 vaccines?

Current Status Health Canada has approved three COVID-19 vaccines to date: Pfizer-BioNTech, Moderna, and most recently, Oxford- AstraZeneca. Both the Pfizer-BioNTech and Moderna vaccines were proven to be over 90% effective against COVID-19 in clinical trials, while the Oxford-AstraZeneca vaccine has proven 60% effective. With concerns over the highly transmissible..... Read More
dreamstime xxl 191198050 canada covid 19 12112020 scaled
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
dreamstime xxl 150888837 2
July 21, 20201

5 Benefits of Artificial Intelligence in Healthcare

1. Take a selfie from your phone and receive a diagnostic Sounds crazy right? Our phone cameras are so detailed, and the quality is only getting better. This trend really complements dermatology and ophthalmology specialties. There are applications that have unique algorithms that can determine features as specific as jawline..... 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
dreamstime xxl 124729831 upside down man 3
June 17, 2021Like

Health Canada’s newest regulatory pathway is for products that don’t quite ‘fit’

Effective novel and complex medicines are emerging. As science and technology progresses towards increasingly complex and personalized medicines, regulators have recognized the need for a more agile approach to licensing and compliance. The current regulatory framework simply doesn’t work for a select group of very novel, very complex products. Need..... Read More
pharmacist and doctor study info about tablets 05272021
June 7, 20211

An update on the new Structured Product Monograph (SPM)

Product Monographs are used to provide information about the appropriate use of a drug to physicians, pharmacists, nurses, healthcare professionals, and consumers. Health Canada aims to harmonize the structure of Product Monographs and convert them into a structured format called Structured Product Monograph (SPM) as a part of a regulatory..... Read More
dreamstime xxl 202580320 women on couch telehealth
May 28, 20211

Tips on conducting clinical trials during the pandemic.

As always, ensure patient safety remains the top priority. The COVID-19 pandemic has impacted the health risks associated with running ongoing clinical trials. As a result, Sponsors must take the initiative to implement measures to reduce or prevent the risk of becoming infected with COVID-19. One should consider the availability..... Read More
Customer scanning product through cell phone 03302021 2
March 30, 20212

Did you know that Health Canada now requires Drug Labelling in SPM format?

Health Canada is adapting its systems with advances in science to maximize the safety of Canadians, and one of their initiatives is to improve drug product labels. The Agency recognizes that the publicly available labelling information should be transitioned from unstructured formats, like Portable Document Format (PDF), to an advanced..... Read More
iStock 000003420564Large chimp resized
March 19, 20211

So, what’s going on with the AstraZeneca vaccine?

After several reports on European countries suspending the use of the AstraZeneca COVID-19 vaccine, many Canadians are wondering if it is safe to use.   What you should know Law – Manufacturers in the pharmaceutical industry are required by law to report Adverse Drug Reactions (ADRs) to regulatory agencies such..... Read More
gavel
March 2, 20212

Health Canada issues a new Interim Order for COVID-19 products

At the start of the COVID-19 pandemic, Health Canada issued an interim policy to allow the import of products that do not fully meet regulatory requirements, but were comparable, to meet the incredibly high demand for disinfectants and hand sanitizers. This policy allowed the government to resolve 25 Tier 3..... Read More
Health Canada approved COVID-19 vaccines
February 26, 20212

How effective are Health Canada approved COVID-19 vaccines?

Current Status Health Canada has approved three COVID-19 vaccines to date: Pfizer-BioNTech, Moderna, and most recently, Oxford- AstraZeneca. Both the Pfizer-BioNTech and Moderna vaccines were proven to be over 90% effective against COVID-19 in clinical trials, while the Oxford-AstraZeneca vaccine has proven 60% effective. With concerns over the highly transmissible..... Read More
dreamstime xxl 191198050 canada covid 19 12112020 scaled
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
dreamstime xxl 150888837 2
July 21, 20201

5 Benefits of Artificial Intelligence in Healthcare

1. Take a selfie from your phone and receive a diagnostic Sounds crazy right? Our phone cameras are so detailed, and the quality is only getting better. This trend really complements dermatology and ophthalmology specialties. There are applications that have unique algorithms that can determine features as specific as jawline..... 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
microsoft erp for life sciences
April 2, 20161

Press Release – AXOQCS™ Microsoft ERP for Life Sciences

AXOQCS™ is complete business solution developed for Microsoft Dynamics AX that provides quality and compliance functionality Milton, ON – AxSource® Global, the leading Microsoft DynamicsTM Partner in North America, announces today an extension of its pioneer enterprising product portfolio – it’s new product, AXOQCSTM (pronounced “AXO”-“QCS”) – an augmented IT solution..... Read More
dreamstimesmall 1128808
July 8, 20161

Press Release – New Medical Device Clients For AXOQCS™

New Medical Device Clients For AXOQCS™: Rapid Self Test Inc. And Body Heat Pads Inc. AXOQCS™ is a complete business solution developed for Microsoft Dynamics AX that provides quality and compliance functionality for companies in the life sciences industry Milton, Ontario – (April 15, 2016): AXSource® Global, the leading Microsoft Dynamics™ Partner..... Read More
Health Canada to start providing public access to protected drug and medical device data
March 25, 2019Like

Greater Healthcare Transparency for Canadians: Health Canada to start providing public access to protected drug and medical device data

Millions of Canadians rely on drugs and medical devices to maintain their quality of life and overcome medical ailments. However, access to the clinical evidence that is used to approve these therapeutic products is restricted to Health Canada. Consequently, Canadians are shielded from safety issues, adverse events, and results from..... Read More