Welcome to the CAPRA Blog
Pan-Canadian Pharmaceutical Alliance for Generic Drugs
All 13 Provinces and Territories have been working together to achieve greater value for brand name and generic drugs for publicly funded drug programs. These initiatives, formerly known as the Pan-Canadian Pricing Alliance and the Generic Value Price Initiative, are now referenced collectively as the pan-Canadian Pharmaceutical Alliance (pCPA).
Validation Rules for Regulatory Transactions Submitted in the electronic Common Technical Document (eCTD) Format
Late last year, Health Canada announced the revised validation rules for regulatory transactions in the electronic Common Technical Document (“eCTD”) format.
Health Canada’s Guidance on Applications for Medical Device Investigational Testing Authorizations
In late 2017, Health Canada released a draft guidance document to assist sponsors, manufacturers, and importers on the authorization process for investigational testing of medical devices. The draft guidance, titled “Applications for Medical Device Investigational Testing Authorizations”, is open for consultation and supersedes the previous guidance document from 1999 (“Preparation of an Application for Investigational Testing – Medical Devices”).
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
In late 2017, Health Canada published a new guidance document concerning HIV RDTs, titled “Guidance for Manufacturers of Human Immunodeficiency Virus (HIV) Rapid Diagnostic Tests (RDTs) for use at the Point of Care or for Self-Testing” (the “Guidance Documents”). The Guidance Document provides manufacturers of Class IV HIV RDTs for point of care or self-testing applications with specific guidance on the analytical and clinical data as well as labelling considerations as part of the device application process.
Health Canada’s Notice on the Medical Device Single Audit Program
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
Last month the ACSS Consortium announced the launch of the Generic Medicines Work Sharing Trial, an innovative work sharing model for the coordinated assessment of applications for generic medicines.
ICH Publishes New Guidance on Pediatric Clinical Trials and Genomic Data
The ICH has published and adopted two new guidance documents relating to drug development.
Health Canada’s Proposed Cannabis Regulatory Framework
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 restricted access to cannabis for recreational purposes, as well as regulate its production, importation, exportation, distribution, sale, and possession.
New Guidance Document: Use of a Foreign-sourced Reference Product as a Canadian Reference Product
On November 24, 2017 Health Canada published the Guidance Document “Use of a Foreign-sourced Reference Product as a Canadian Reference Product”, for sponsors who are seeking to demonstrate pharmaceutical equivalence and bioequivalence with a Canadian Reference Drug under paragraph (c) of C.08.001.1 of the Food and Drug Regulations. The Guidance Document replaces previous guidance which had been in place since 1995.
Toward a Strengthened Assisted Human Reproduction Act
The increase in infertility in Canada has seen many Canadians turn to assisted human reproductive technologies to assist with family planning.
Guidance Document - Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs)
On October 30, 2017, Health Canada released the final version of the Guidance Document - Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (“NDS”) and Abbreviated Drug Submissions (“ANDS”)
Proposed Amendments to the Patented Medicines Regulations
A significant portion of all healthcare-related expenditures in Canada is attributed to prescription drugs. Despite this, prescription drug costs have continued to rise, with Canada having some of the world’s highest prices for prescription drugs.