What’s New – Regulatory Edition – Health Canada and FDA Updates
What’s New – Regulatory Edition – Health Canada and FDA Updates
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Health Canada’s PRCI Process – A Deep Drive into Transparency
Transparency in the approval and regulation of health products is crucial for maintaining public trust, ensuring patient safety, and enabling informed decision-making. Health Canada has taken significant advances toward ensuring transparency in its drug approval process. One of the key initiatives in this effort is the Public Release of Clinical Information (PRCI) process. This process …
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ICH M4Q(R2): An Update from ICH and CAPRA
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) plays a key role in global pharmaceutical regulatory alignment. The ICH M4Q(R2) guideline, a revision of the M4Q(1) (2002) guideline, aims to improve the efficiency of pharmaceutical submissions and lifecycle management. M4Q(R2) includes a restructuring of Module 2 and Module 3 …
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Updates to Health Canada’s Quality Guidance: New Drug Submissions and Abbreviated New Drug Submissions (December 2024)
Health Canada has introduced significant updates to its Quality (Chemistry and Manufacturing) Guidance for New Drug Submissions and Abbreviated New Drug Submissions. These changes, effective December 2024, are part of Health Canada’s modernization work and reflect changes in regulatory expectations since the 2018 version. The following key updates have been introduced: Nitrosamine Risk Assessment (S.3.2, …
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Why and How – Health Canada Master Files
The Master File (MF), formerly Drug Master File (DMF), is a regulatory filing used to provide supporting submission information to Health Canada, without revealing the contents to the sponsor of the drug submission. Health Canada is bound to protect the confidential business information (CBI) in the MF in compliance with the Food and Drugs Act …
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Navigating Risk Assessment in Ontario: An Overview of Ontario Regulation 153/04 Risk Assessments and Due Diligence Risk Assessments
Navigating Risk Assessment in Ontario: An Overview of Ontario Regulation 153/04 Risk Assessments and Due Diligence Risk Assessments What is a Risk Assessment? A risk assessment (RA) is an evaluation which estimates the likelihood and magnitude of adverse effects resulting from exposure of both human and ecological receptors to environmental contaminants. In Ontario, contaminated sites …
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Changes to Alberta Tier 1 Soil and Groundwater Remediation Guidelines for Human Health for Dioxins and Furans Explained
Alberta Environment and Protected Areas (EPA) released an update to the Alberta Tier 1 Soil and Groundwater Remediation Guidelines on June 27, 2024. As part of that update, changes were made to the Alberta Tier 1 Soil and Groundwater Remediation Guidelines for dioxins and furans. The changes are based on the findings of a panel …
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Acceptable Intake Limits Now More Clearly Defined for Nitrosamine Impurities and Nitrosamine Drug Substance-Related Impurities (NDSRIs)
Nitrosamines are a class of compounds with the chemical structure shown in Figure 1. In the International Council for Harmonisation (ICH) M7(R1) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk guidance document (ICH 2018), nitrosamine compounds were identified as a “cohort of concern” based on potent genotoxicity observed …
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Ethylene Glycol and Diethylene Glycol Contamination Risks and FDA’s New Guidance on Testing in High-Risk Drug Components
The FDA has recently issued new guidance for the pharmaceutical industry regarding the testing of ethylene glycol (EG) and diethylene glycol (DEG) in high-risk drug components in response to recent reports of fatal poisoning from DEG- or EG-contaminated oral liquid drug products1. In early 2023, the World Health Organization (WHO) issued worldwide health alerts regarding …
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Climate Change and Health Vulnerability Assessments
Introduction Climate change and population health are intrinsically intertwined. The impacts of climate change on health, safety and well-being are extensive and wide-ranging. These impacts include fatalities and injuries due to severe storms, landslides and floods; an increase in infectious diseases, including those from water-borne pathogens; heat-related illness and respiratory and cardiovascular disorders; increased UV …
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Risk Assessment and Traditional Food Consumption
Traditional food refers to those foods that are harvested from the local environment, including small and large game, birds, fish, and plants. Diets that include traditional foods are often more nutritious than those of market foods alone. Hunting, harvesting and preparing traditional foods with family and community members facilitates intergenerational knowledge transfer and contributes to cultural …
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Digging for Answers in Ontario’s Excess Soil Regulation and Beneficial Reuse Assessment Tool (BRAT)
Excess soil and the benefits of excess soil reuse Excess soil refers to soil that has been excavated from a site (typically during construction or redevelopment activities), which can no longer be used at the development site. Local reuse of excess soil can have many financial and environmental benefits associated with marked reductions in transportation …
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Priority Review vs NOC/c – Which Pathway is Right for Me?
Drug development and innovation is incredibly important to those with life-threatening and severely debilitating conditions. The process of getting a drug from discovery to the market is lengthy, taking an average of 10 years. However, expediting the process is difficult, as research and clinical trials take up a significant amount of time and cannot be …
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New Soil and Groundwater Quality Guidelines from the Canadian Council of Ministers of the Environment and Implications for Contaminated Sites Assessment in Canada
The Canadian Council for Ministers of the Environment (CCME) released soil and groundwater quality guidelines (see Table below) for the protection of human and ecological health for perfluorooctane sulfonate (PFOS) on September 21, 2021. CCME (2021) Soil Quality Guidelines for the Protection of Human and Ecological Health for Various Land Uses Agricultural Residential/Parkland Commercial Industrial …
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Health Impact Assessment in Canada’s Impact Assessment Process
Introduction The new Canadian federal Impact Assessment Act requires that human health be assessed by employing the “best practices in Health Impact Assessment methods” for federally designated projects. As such, under the new Impact Assessment (IA) process, there is a greater focus on assessing the potential impacts on human health and well-being. The new requirements …
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