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November 4, 2021Like

Have you heard of Good Machine Learning Practice (GMLP)?

Health Canada, the US Food & Drug Administration, and the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) have collaborated to identify 10 guiding principles to govern the development of Good Machine Learning Practice (GMLP). Medical devices that use artificial intelligence (AI) and machine learning (ML) technologies are increasingly recognized..... Read More
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September 30, 20212

FDA enhances its KASA System for Drug Substance

What is KASA? KASA is an assessment tool that was designed to maximise the efficiency of the regulatory review process. The tool relies on structured data to eliminate some of the redundancies of more traditional assessment formats (narrative text and lengthy summaries). KASA stands for Knowledge-Aided Assessment and Structure Application..... Read More
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July 30, 20212

5 Common Hurdles with CSV

In today’s health product industry, software systems are commonly used in manufacturing, inventory control and Quality Management Systems (e.g., complaint handling, CAPA management, document control). Due to their impact on product quality compliance, regulatory agencies such as FDA, Health Canada and EMA, to name a few, require that computerized systems..... Read More
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June 17, 20212

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
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June 7, 20212

An update on the new XML Product Monograph (XML PM)

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 the XML Product Monograph (XML PM) as a part of..... Read More
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May 28, 20212

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
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March 30, 20212

Did you know that Health Canada now requires Drug Labelling in XML PM 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
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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
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