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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
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
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
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
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
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)
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?
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.
Summary on Recent Intellectual Property Hold for Notifiable Change Submissions
On April 7th, 2017, Health Canada released the Intellectual Property Hold for Notifiable Change Submissions notice. This notice is geared towards subsequent entry manufacturers and sponsors as per the Patented Medicines (Notice of Compliance) Regulations and the Food and Drug Regulations.
An Update on the Regulatory Progress of Biosimilars in Canada, the EU and the U.S.
In the last 10 years, biosimilar regulatory guidelines have evolved significantly in Canada, the European Union (EU) and the United States of America (U.S.). Anchored on the patent expiration date, there is a wave of biosimilars development in Western countries as well as other countries – all demanding cheaper versions of biologic medicines for their citizens.
Plain Language Labelling Summary
A few years ago on June 13th, 2015, the Plain Language Labelling Regulations became effective for prescription drugs in Canada.
Health Canada Begins Consultations on Mandatory Reporting by Health Care Institutions
Health Canada has commenced consultations on proposed changes to the Food and Drug Regulations and Medical Devices Regulations that would require mandatory reporting of serious adverse drug reactions and medical device incidents by health care institutions.