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Health Canada Getting Tougher on Opioid and Illegal Advertising
Author: John Wong, Director, Regulatory Drug Advertising & Promotion, TPIReg/Inomar Strategies In light of the on-going and escalating opioid crisis, the Federal Health...
Guidance Document Regarding Administrative Processing of Submissions and Applications: Human or Disinfectant Drugs
Author: Bhavesh Patel, C. Chem. Health Canada recently published a guidance document to clarify the requirements for eligible drug submissions and applications processed...
Release of Draft Guidance Document: Regulatory Requirements for Drug Identification Numbers (DINs)
Author: Karen Zhou Health Canada recently released a draft guidance on regulatory requirements for Drug Identification Numbers (DINs). The intent of the document is to...
Health Canada Notice on the Discontinuation of Acknowledgement Letters for Regulatory Activities
Author: Pinky Mazumder On January 30, 2019, Health Canada published a Notice announcing a proposal to discontinue acknowledgement letters (Acknowledgement of Information...
Canadian Cannabis Survey 2018
Health Canada has been actively collecting data to better understand how Canadians view and use cannabis.
Health Canada Assessment Suggests that Talc May be Harmful to Human Health
In late 2018, Health Canada and Environment and Climate Change Canada announced the completion of the draft screening assessment of talc. Talc (Chemical Abstracts Service Registry Number 14807-96-6) is a naturally occurring mineral typically found in consumer products (e.g. cosmetics, natural health products, talcum powder, food, plastics, paper).
Health Canada Requests Feedback on Potential Impacts and Uses if Company Names were added to the Generic Submissions Under Review List
Health Canada has recently requested feedback on a Phase III premarket transparency initiative to include the name of the sponsor on the list of new drug submissions and supplements for new uses currently under review.
Improving Safety, Effectiveness and Quality – The Medical Device Action Plan
In a sweeping move to strengthen the safety, effectiveness and quality of medical devices, Health Canada has rolled out a three part Medical Device Action Plan for 2019.
Summary of Annual Trends of Adverse Reaction Case Reports submitted to Health Canada
With the purpose of protecting the health of Canadians and monitoring the safety of products on the market, Health Canada collects reports of health product adverse events from manufacturers/importers as well as from healthcare professionals.
Post-NOC Level III Change Updates
A post-NOC change is any change made to a new drug that has received a notice of compliance (NOC) pursuant to C.08.004 of the Food and Drug Regulations.
Cybersecurity – Draft Guidance Document
Medical devices play a pivotal and ever increasing role in improving access to care for patients. Through data exchange with network environments, medical devices facilitate timely diagnoses and treatments and improve access to healthcare information. The tradeoff is that that devices can become vulnerable to cyberattacks.
Proposed Amendments to Regulations under the Ontario Drug Benefit Act and the Drug Interchangeability and Dispensing Fee Act
The Ministry of Health & Long-Term Care recently announced proposed amendments to the regulatory scheme affecting private label drug products.