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Antimicrobial Resistance and Health Canada’s Pathogens of Interest List
Author: Pinky Mazumder Antimicrobial resistance is currently recognized as a worldwide public health concern due to difficulty in treatment. In response, Health Canada is...
ICH E18: Genomic Sampling and Management of Genomic Data
Author: Bhavesh Patel, C. Chem. Health Canada recently announced the implementation of ICH guidance E18: Genomic Sampling and Management of Genomic Data (the “Guidance”). The...
Consultation on Prescription Drug Transparency
Author: Pinky Mazumder From September 28th to October 28th 2017, the Therapeutic Products Directorate (TPD) of Health Canada held an online consultation on five proposed...
Final Notice: Classification of Dental Plaque-Disclosing Products as Drugs
Author: Bhavesh Patel, C. Chem. Last month, Health Canada posted a notice for consultation with industry and other stakeholders of its intention to regulate dental...
Australia Canada Singapore Switzerland (ACSS) Consortium - New Chemical Entities Work Sharing Trial Phase I
Author: Karen Zhou The Australia Canada Singapore Switzerland (ACSS) Consortium was established to foster collaboration and synergy between regulatory authorities to address...
Health Canada Notice on eCTD submission of Master Files
Author: Pinky Mazumder On May 7, 2018 Health Canada published a notice announcing the start of a 90-day consultation on the submission of Master Files in eCTD format....
Medical Device Single Audit Program Reduction of Audit Times for small-sized enterprises – update
Author: Bhavesh Patel, C. Chem. Health Canada is continuing to work towards the target date of January 1, 2019 to transition to MDSAP Quality Management System certificates...
Health Canada implements ICH guidance E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population
Author: Karen Zhou Health Canada has announced the implementation of the ICH guidance E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric...
Health Canada Adapts to Digital Health Technologies
Author: Pinky Mazumder Digital health technologies are a rapidly growing area in the area of healthcare. These technologies encompass a wide range of products, from single...
Release of Proposed IMDRF Document: Definitions for Personalized Medical Devices
Author: Bhavesh Patel, C. Chem. The International Medical Device Regulators Forum (IMDRF) recently published a Proposed Guidance Document titled Definitions for Personalized...
Health Canada Continues to Tweak Requirements for MDSAP Transition
Author: Karen Zhou Manufacturers who sell medical devices in the Canadian market are required to submit MDSAP certificates by December 31, 2018. The Medical Device Single...
Health Canada Notice on ICH Selection and Justification of Starting Materials for the Manufacture of Drug Substances
Author: Pinky Mazumder On April 4th, 2018 Health Canada issued a Notice to announce its implementation of the ICH Q11 final guidance document on Questions and Answers:...
Health Canada: Guideline for Residual Solvents
Author: Bhavesh Patel, C. Chem. Health Canada recently announced the implementation of the ICH Guidance “Q3C(R6) Impurities: Guideline for Residual Solvents” (the “Guidance”)...
The Australia Canada Singapore Switzerland (ACSS) Consortium
Author: Pinky Mazumder With the evolving nature of medicines and treatments, regulatory agencies across the world are encountering similar challenges during the review and...
Administrative Processing of Submissions and Applications: Human or Disinfectant Drugs
Author: Bhavesh Patel, C. Chem. On March 1, 2018, the guidance document “Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs” (the...
CADTH Revisions to the Biosimilar Review Process and Resubmission
Author: Pinky Mazumder In late 2017, the Canadian Agency for Drugs and Technologies in Health (“CADTH”) announced an open consultation on proposed changes to the Common Drug...
Regulatory Enrollment Process and the Use of the Common Electronic Submission Gateway for Medical Devices
Author: Bhavesh Patel Health Canada is considering a pilot of the Regulatory Enrolment Process (“REP”) using the Common Electronic Submission Gateway (“CESG”) for Medical...
Health Canada’s Adoption of ICH M7
Author: Pinky Mazumder On January 19, 2018 Health Canada announced the adoption of the ICH guidance on M7: The Assessment and Control of DNA Reactive (Mutagenic) Impurities...
Health Sector Payment Transparency Act, 2017 - New Regulation
Author: Bhavesh Patel The Ministry of Health and Long-Term Care for the Province of Ontario recently published draft Regulations for the recently enacted Health Sector...
ICH Draft on Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Q12
Author: Pinky Mazumder On November 16, 2017 the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (“ICH”) published a draft...
Pan-Canadian Pharmaceutical Alliance for Generic Drugs
Author: Bhavesh Patel, C. Chem. All 13 Provinces and Territories have been working together to achieve greater value for brand name and generic drugs for publicly funded drug...
Validation Rules for Regulatory Transactions Submitted in the electronic Common Technical Document (eCTD) Format
Author: Bhavesh Patel, C. Chem. Late last year, Health Canada announced the revised validation rules for regulatory transactions in the electronic Common Technical Document...
Health Canada’s Guidance on Applications for Medical Device Investigational Testing Authorizations
Author: Pinky Mazumder In late 2017, Health Canada released a draft guidance document to assist sponsors, manufacturers, and importers on the authorization process for...
Guidance Document - Guidance for Manufacturers of Human Immunodeficiency Virus (HIV) Rapid Diagnostic Tests (RDTs) for use at the Point of Care or for Self-Testing
Author: Bhavesh Patel, C. Chem. In late 2017, Health Canada published a new guidance document concerning HIV RDTs, titled “Guidance for Manufacturers of Human...
Health Canada’s Notice on the Medical Device Single Audit Program
Author: Pinky Mazumder Late last year, Health Canada issued a notice to the industry on the reduction of audit times for the Medical Device Single Audit Program (“MDSAP”)....