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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Author: Pinky Mazumder In late 2017, Health Canada released a draft guidance document to assist sponsors, manufacturers, and importers on the authorization process for...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”)....
The ACSS (Australia-Canada-Singapore-Switzerland) Consortium and the Generic Medicines Work Sharing Trial
Author: Bhavesh Patel, C. Chem. Last month the ACSS Consortium announced the launch of the Generic Medicines Work Sharing Trial, an innovative work sharing model for the...
ICH Publishes New Guidance on Pediatric Clinical Trials and Genomic Data
Author: Bhavesh Patel, C. Chem. The ICH has published and adopted two new guidance documents relating to drug development. The first document, an addendum to ICH E:11...
Health Canada’s Proposed Cannabis Regulatory Framework
Author: Pinky Mazumder Bill C-45, the proposed Cannabis Act (the “Act”) , was introduced earlier in 2017 and is scheduled to be in force by July 2018. The Act will provide...
New Guidance Document: Use of a Foreign-sourced Reference Product as a Canadian Reference Product
Author: Bhavesh Patel, Chartered Chemist On November 24, 2017 Health Canada published the Guidance Document “Use of a Foreign-sourced Reference Product as a Canadian...
Toward a Strengthened Assisted Human Reproduction Act
Author: Pinky Mazumder The increase in infertility in Canada has seen many Canadians turn to assisted human reproductive technologies to assist with family planning. With the...
Guidance Document - Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs)
Author: Bhavesh Patel, C. Chem. Natco Pharma (Canada) Inc. On October 30, 2017, Health Canada released the final version of the Guidance Document - Quality (Chemistry and...
Proposed Amendments to the Patented Medicines Regulations
Author: Pinky Mazumder A significant portion of all healthcare-related expenditures in Canada is attributed to prescription drugs. Despite this, prescription drug costs have...
Certificate of Supplementary Protection for Pharmaceuticals, Biologics and Veterinary Drugs.
Author: Bhavesh Patel, C. Chem. Natco Pharma (Canada) Inc. Health Canada has released the Guidance Document - Certificate of Supplementary Protection Regulations which...
Health Canada’s guidance on Fees for Review of Submissions
Author: Pinky Mazumder Health Canada's guidance document on the Fees for the Review of Drug Submissions and Applications provides sponsors information concerning the fees...
Patented Medicines (Notice of Compliance) Regulations due to Comprehensive Economic and Trade Agreement (CETA)
Author: Bhavesh Patel, C. Chem. Natco Pharma (Canada) Inc. Health Canada recently published the Notice - Patented Medicines Notice of Compliance Regulations as an update for...
FDA Regulatory Reform
Author: Pinky Mazumder On September 8th, 2017, the Food and Drug Administration signaled the start of a major regulatory overhaul by publishing a docket in the Federal...
Ontario to Require Public Disclosure of Industry Payments to Health Care Professionals
Author: Mark Vanderveken On September 27, 2017, the Government of Ontario tabled a bill to enact the Health Sector Payment Transparency Act, 2017, (the “Act”) which will...
First Nations Health Authority (FNHA) Transition to BC Pharmacare
Author: Bhavesh Patel, C. Chem., Natco Pharma (Canada) Inc. Beginning October 1, 2017, the FNHA will partner with BC PharmaCare to administer the FNHA PharmCare plan - a...
New Health Canada Consultation on Low-Dose Codeine Products
Author: Pinky Mazumder On September 9th 2017, Health Canada released a notice in Canada Gazette Part I concerning the non-prescription availability of low-dose codeine...
Health Canada’s Proposed Modification for Multiphasic Modified Release Drugs
Author: Pinky The guidance on Comparative Bioavailability Standards: Formulations Used for Systemic Effects provides sponsors with standards and parameters to consider for...
Health Canada-Use of Certificates of Suitability as supporting information in Drug Submissions
Author: Pinky Mazumder What are CEPs Certificates of Suitability (CEPs), issued by the European Directorate of Quality of Medicines and Healthcare (EDQM), are used to support...
Changes to the Manufacturer's name and/or Product Name
Author: Pinky Mazumder The Policy on Changes in Manufacturer’s name and/or Product Name (CMPN) applies to drug submissions to Health Canada where the manufacturer's and/or...
Comprehensive Economic and Trade Agreement (CETA) and Canada’s Pharmaceutical Sector
Author: Bhavesh Patel, C. Chem. Natco Pharma (Canada) Inc. On October 30th, 2016, Prime Minister Justin Trudeau, European Commission President Jean-Claude Juncker and...
Changes to the Annual Drug Notification Form (ADNF)
Author: Bhavesh Patel, C. Chem. Natco Pharma (Canada) Inc. Editor: Madhur Jadawala, B.Sc. Pharm. Quality & Compliance Services Inc. On March 14, 2017, Health Canada published...
Planning to File Your 505(b)(2) Product in Canada?
Author: Dr. Jan Sedgeworth Vice President, Regulatory Affairs at Intrinsik Corp. Canada may not be top of the list of countries that companies target for first registration...