Search Results for Health Canada

Showing 1 – 14

Health Canada Seeks to Update User Fees for Drug and Device Firms By Zachary Brennan - Published 13 October 2017

Health Canada this week opened for consultation a proposal to update and increase some of the fees it assesses for pharmaceutical and medical device companies, noting that the last update came in 2011 and was based on 2007 data.

Categories: News, Canada, Health Canada, Biologics and biotechnology, Drugs, Government affairs, Submission and registration, Veterinary products

Tags: pharmaceutical fees, medical device fees, Health Canada fees

Canada Reimbursement Profile By Matthew Brougham, MSc, William O'Neil, PhD, Dima Samaha, MAS, PharmD - Published 04 October 2017

This profile summarizes reimbursement processes in Canada, presents information for key stakeholders and highlights what should be considered early in the development process.

Categories: Features, Canada, Health Canada, Drugs, Medical Devices, Reimbursement

Tags: CADTH, Health Canada, INESSS, pCPA, PMPRB

Health Canada Opens Consultation on Mandatory Adverse Drug Reaction, Device Incident Reports By Zachary Brennan - Published 28 June 2017

Health Canada on Tuesday opened up a consultation on changes to the country's Food and Drug Regulations and Medical Devices Regulations that would make it mandatory for certain health care institutions to report serious adverse drug reactions (ADRs) and medical device incidents (MDIs).

Categories: News, Canada, Health Canada, Drugs, Government affairs, Medical Devices, Postmarket surveillance

Tags: Health Canada, Vanessa's Law, adverse event reporting

Health Canada Looks to Raise the Bar for Regulating Natural Health Products By Zachary Brennan - Published 04 October 2016

A controversial new proposal from Health Canada would add new regulatory scrutiny for natural health products and bring them in line with higher scientific standards used to regulate over-the-counter drugs.

Categories: News, Canada, Health Canada, Cosmetics, Over the counter drugs, Nutritional and dietary supplements

Tags: Health Canada, natural health products, cosmetics, OTC drugs, non-prescription drugs

Health Canada Updates Bioavailability Requirements for Highly Variable Drugs By Zachary Brennan - Published 18 April 2016

Health Canada on Monday unveiled new comparative bioavailability requirements for drugs exhibiting large pharmacokinetic within-subject variation in terms of absorption.

Categories: News, Canada, Health Canada, Clinical, Drugs, Research and development

Tags: Health Canada, bioequivalence, highly variable drug products, bioavailability, pharmacokinetic

Health Canada Details New Confidential Info Disclosures in Draft Guidance By Zachary Brennan - Published 14 March 2016

Health Canada is proposing to disclose more confidential business information (CBI) to eligible persons for the purpose of protecting or promoting human health or the safety of the public, according to new draft guidance.

Categories: News, Canada, Health Canada, Clinical, Drugs, Government affairs, Manufacturing, Medical Devices, Postmarket surveillance, Quality

Tags: Health Canada, confidential business information, confidential data

Pfizer, Health Canada Recall Children’s Advil After 'Clump' Concerns By Zachary Brennan - Published 15 February 2016

Pfizer is voluntarily recalling 126 lots of Advil liquid products for infants and children in Canada because “clumps” may form in the bottles affected and lead to higher or lower doses given to infants and children if the products are not shaken well before each use.

Categories: News, Canada, Health Canada, Crisis management, Product withdrawl and retirement, Quality

Tags: Pfizer, children's Advil, infant Advil, Health Canada

Health Canada Outlines 2016 Deficiencies at Actavis, Sanofi, Gilead and Other Manufacturing Facilities By Zachary Brennan - Published 05 February 2016

As part of Health Canada’s transparency push, the regulator is unleashing new information about its work, including an updated good manufacturing practice (GMP) inspection database that reveals new GMP deficiencies for Actavis, Sanofi-Aventis, Gilead, Baxter and other manufacturing facilities from inspections conducted in January 2016.

Categories: News, Canada, Health Canada, Audit, Biologics and biotechnology, Compliance, Drugs, Manufacturing, Medical Devices, Quality

Tags: Health Canada, Gilead, Sanofi, Actavis, Baxter, GMP inspections

Health Canada Makes New Transparency Pledge By Zachary Brennan - Published 27 January 2016

Over the next three years, Health Canada says it will enhance its early warning systems on drug and device safety issues, particularly those in other countries, further communicate explanations for regulatory decisions and update and expand guidance on regulatory requirements.

Categories: News, Canada, Health Canada, Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Medical Devices, Postmarket surveillance

Tags: Health Canada, GMP inspections, quality control, data integrity

Health Canada to Require Precautionary Statements in Antimicrobial Labels By Zachary Brennan - Published 16 November 2015

As part of efforts to encourage the more prudent prescribing and use of antimicrobials, Health Canada on Monday announced it will now require the inclusion of precautionary statements in antimicrobial product labelling.

Categories: News, Canada, Health Canada, Active pharmaceutical ingredients, Crisis management, Drugs, Labeling, Regulatory intelligence, Regulatory strategy

Tags: Health Canada, antimicrobials, antibiotics, superbugs, drug labels, labeling

Health Canada Overruled on Apotex Import Ban By Zachary Brennan - Published 04 November 2015

A Canadian federal court has ruled against Health Canada’s decision to restrict pharmaceutical imports from two Apotex facilities in India, though the US FDA still bans products from these facilities.

Categories: News, India, Canada, US, FDA, Health Canada, Drugs, Manufacturing, Postmarket surveillance, Product withdrawl and retirement, Quality, Regulatory intelligence, Regulatory strategy

Tags: Apotex, Health Canada, data integrity, India drug manufacturing, Rona Ambrose

Canada's Medical Marijuana Regulations, An Overview By Rachelle D'Souza - Published 26 August 2015

This article presents an overview of Canada's medical marijuana regulations regarding individual prescription access and compliance measures for licensed producers.

Categories: Articles, Features, Canada, Health Canada

Tags: marijuana, medical marijuana, Canada, Health Canada

US Bests Canada in Approving New Drugs to Treat Cancer, Study Finds By Michael Mezher - Published 28 January 2015

A new study appearing in the medical journal Cancer this week examines the differences in approval times for cancer drugs at the US Food and Drug Administration (FDA) and Health Canada.

Categories: News, Canada, US, FDA, Health Canada, Prescription drugs, Regulatory intelligence, Regulatory strategy, Reimbursement, Submission and registration

Tags: Cancer, Oncology, Drug Approvals, FDA vs Health Canada

Latest Information on Health Canada Review and Approval Times for MDEL Applications By Stewart Eisenhart, Emergo Group - Published 25 September 2014

Health Canada regularly publishes performance data with respect to Medical Device License applications (Class 2-4); however, the data publically available for Medical Device Establishment License (MDEL) applications has generally been limited.  To gain a better understanding of MDEL applications, Emergo's Vancouver office contacted Health Canada under Canada’s Access to Information Act asking for additional information.

Categories: News, Canada, Health Canada, Manufacturing, Medical Devices, Submission and registration

Tags: Canada, Health Canada, MDEL, Medical Device Establishment License