The FDA is seeking feedback on its document entitled Decentralized Clinical Trials for Drugs,...
Health Canada
ICH E6(R3) Guideline on Good Clinical Practice Available for Public Comment
Recently, Health Canada announced the ICH E6(R3) Guideline on Good Clinical Practice is available...
Health Canada is Seeking Feedback
Health Canada is seeking feedback on a search portal being built to replace the existing Clinical...
U.S. FDA and Health Canada will be co-hosting a regional public consultation
The U.S. FDA and Health Canada will be co-hosting a regional public consultation on Wednesday, May 11, 2022 from 1:00pm-4:00pm EDT to provide information and receive comments on current ICH working group activities and anticipated future topics. The purpose of the...
Health Canada Changes Time for Keeping Clinical trial Records for Drugs and Natural Health Products
Health Canada is pleased to announce they have reduced the period for keeping clinical trial records for drugs and natural health products from 25 years to 15 years. This change reflects amendments to the Food and Drug Regulations and Natural Health Products...
Health Canada’s Consultation Summary
Dr. Carole Légaré from Health Canada spoke at the N2 Annual Conference and provided an overview and results from stakeholder consultations conducted with Health Canada. The consultation summary is now available here.
Register for the upcoming Good Clinical Practice virtual symposium
Register for the upcoming Good Clinical Practice virtual symposium in partnership with the US Food and Drug Administration (FDA) and Health Canada (HC), being held March 7-9, 2022. Register here
Health Canada is looking for your feedback by December 14, 2021
N2 is working in partnership with Health Canada (HC) on their consultation to seek input from Canadians and key stakeholders on their draft of GUI-0043: “Risk classification guide of observations related to clinical trial inspections of human drugs.” Feedback will be...
Submit your COVID-19 related questions for Health Canada by Friday!
To make sure the questions relate to COVID-19 and not the Guide 100 or other Health Canada issues on COVID-19 questions already addressed by the COVID-19 guide, Health Canada would like us to collect questions in advance. We have not received any questions to date, so...
Notice: Expedited Review of Health Product Submissions and Applications to address COVID-19
Date: March 18, 2020 Our file number: 20-104980-839 On March 18, 2020, the Minister of Health approved an Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19. The interim order will enable an expedited review of medical...
Drugs and medical devices recently authorized by Health Canada
As part of Health Canada's commitment to make information available to patients and the public, Health Canada recently shared a News Release related to drugs and medical devices recently authorized by Health Canada. Between July and November 2019, Health Canada...
Vanessa’s Law: Updates & Implications for Members
In 2014, Canada passed C-17, the Protecting Canadians from Unsafe Drugs Act, also known as Vanessa's Law, which empowers Health Canada to develop regulations governing mandatory reporting of SADRs and MDIs to the federal government. HealthCareCAN regularly produces...
Guidance Document: Part C, Division 5 of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects” (GUI-0100)
Health Canada has released their new guidance document for clinical trial researchers to comply with Part C, Div 5 of the Food & Drug Regulations. Review the document here.