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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...
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...
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...
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...
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...
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...
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...
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...
Summary on Recent Intellectual Property Hold for Notifiable Change Submissions
Author: Pinky Mazumder On April 7th, 2017, Health Canada released the Intellectual Property Hold for Notifiable Change Submissions notice. This notice is geared towards...
An Update on the Regulatory Progress of Biosimilars in Canada, the EU and the U.S.
Author: Oxana Iliach, PhD[1] , Raymond Huml MS, DVM, RAC1 Introduction In the last 10 years, biosimilar regulatory guidelines have evolved significantly in Canada, the...
Plain Language Labelling Summary
Author: Pinky Madhur A few years ago on June 13th, 2015, the Plain Language Labelling Regulations became effective for prescription drugs in Canada. This new regulation...
Health Canada Begins Consultations on Mandatory Reporting by Health Care Institutions
Author: Mark Vanderveken and Alanna Tevel Health Canada has commenced consultations on proposed changes to the Food and Drug Regulations and Medical Devices Regulations...
Patients and Philanderers: Why the Ashley Madison Report has Something Important to Say about Cybersecurity Standards for Patient Data
Author: John Beardwood A) Introduction Privacy legislation in Canada, the U.S. and elsewhere, while imposing detailed requirements on issues such as consent, often reverts...