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Health Canada’s guidance on Fees for Review of Submissions

Health Canada’s guidance on Fees for Review of Submissions

Health Canada's guidance document on the Fees for the Review of Drug Submissions and Applications provides sponsors information concerning the fees associated with the review of submissions.

Patented Medicines (Notice of Compliance) Regulations due to  Comprehensive Economic and Trade Agreement (CETA)

Patented Medicines (Notice of Compliance) Regulations due to Comprehensive Economic and Trade Agreement (CETA)

Health Canada recently published the Notice - Patented Medicines Notice of Compliance Regulations as an update for the public regarding the recently implemented amendments to the Patented Medicines (Notice of Compliance) Regulations which came into effect on September 21, 2017 as part of Canada’s obligations under the Comprehensive Economic Trade Agreement with the European Union. 

FDA Regulatory Reform

FDA Regulatory Reform

On September 8th, 2017, the Food and Drug Administration signaled the start of a major regulatory overhaul by publishing a docket in the Federal Register (the “Docket”) requesting input from interested parties regarding unnecessary regulatory burdens

Ontario to Require Public Disclosure of Industry Payments to Health Care Professionals

Ontario to Require Public Disclosure of Industry Payments to Health Care Professionals

On September 27, 2017, the Government of Ontario tabled a bill to enact the Health Sector Payment Transparency Act, 2017, (the “Act”) which will implement reporting of transfers of value from the pharmaceutical and medical device industries to prescribed recipients.

First Nations Health Authority (FNHA) Transition to BC Pharmacare

First Nations Health Authority (FNHA) Transition to BC Pharmacare

Beginning October 1, 2017, the FNHA will partner with BC PharmaCare to administer the FNHA PharmCare plan - a fully paid drug benefits plan for FNHA clients.

New Health Canada Consultation on Low-Dose Codeine Products

New Health Canada Consultation on Low-Dose Codeine Products

On September 9th 2017, Health Canada released a notice in Canada Gazette Part I concerning the non-prescription availability of low-dose codeine products

Health Canada’s Proposed Modification for Multiphasic Modified Release Drugs

Health Canada’s Proposed Modification for Multiphasic Modified Release Drugs

The guidance on Comparative Bioavailability Standards: Formulations Used for Systemic Effects provides sponsors with standards and parameters to consider for pharmacodynamics studies and comparative bioavailability studies against the reference product.

Health Canada-Use of Certificates of Suitability as supporting information in Drug Submissions

Health Canada-Use of Certificates of Suitability as supporting information in Drug Submissions

Certificates of Suitability (CEPs), issued by the European Directorate of Quality of Medicines and Healthcare (EDQM), are used to support the safety and efficacy of drugs. In the Health Canada guidance on Use of Certificates of Suitability as Supporting Information in Drug Submissions, CEPs can be submitted by applicants/sponsors in place of complete manufacturing information or the restricted portion of a Type 1 Active Substance Master File (ASMF)1.

Changes to the Manufacturer's name and/or Product Name

Changes to the Manufacturer's name and/or Product Name

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 product’s name is being changed due to a merger, corporate restructuring, licensing agreement, or a buy-out. According to this Health Canada Policy, a licensing agreement is defined as “an agreement between two firms whereby one firm supplies a drug product to another firm for sale under the second firm’s name”.

Comprehensive Economic and Trade Agreement (CETA) and Canada’s Pharmaceutical Sector

Comprehensive Economic and Trade Agreement (CETA) and Canada’s Pharmaceutical Sector

On October 30th, 2016, Prime Minister Justin Trudeau, European Commission President Jean-Claude Juncker and European Council President Donald Tusk signed the Comprehensive Economic and Trade Agreement (CETA) during the European Union-Canada Leaders’ Summit in Brussels, Belgium.

Changes to the Annual Drug Notification Form (ADNF)

Changes to the Annual Drug Notification Form (ADNF)

On March 14, 2017, Health Canada published a notice outlining upcoming changes to the Annual Drug Notification Form.

Planning to File Your 505(b)(2) Product in Canada?

Planning to File Your 505(b)(2) Product in Canada?

Canada may not be top of the list of countries that companies target for first registration of their product (although it may be for orphan drugs – however, that’s a subject for another day!), but it’s usually in the next tier after USA and Europe, since typically Canada represents about 10% of the market size of the USA.