On April 4, 2018, Québec’s Institut national d’excellence en santé et en services sociaux (INESSS) released a notice to manufacturers announcing further details on the evaluation process.
Pre-NOC Evaluations
Manufacturers can submit an application for registration to INESSS for a new innovative drug product, a new biosimilar drug product, a new product ... Read More
05
Apr2018
29
Mar2018
Reminder: New prices for generics under pCPA/CGPA agreement become effective April 1st, 2018
In January 2018, the pan-Canadian Pharmaceutical Alliance (pCPA) and the Canadian Generic Pharmaceutical Association (CGPA) announced a five-year agreement that will reduce drug prices for all Canadians who use prescription generic drugs, participating public drug plans, and employee ... Read More
21
Mar2018
Since launching a pilot project to expand clinician participation in the pan-Canadian Oncology Drug Review (pCODR) process in February 2016, the Canadian Agency for Drugs and Technologies in Health (CADTH) has received input from clinicians, the pCODR Expert Review Committee and the Provincial Advisory Group on ways to enhance ... Read More
09
Mar2018
On March 8, 2018, the Canadian Agency for Drugs and Technologies in Health (CADTH) released a new CDR Update (Issue 134).
CADTH Common Drug Review Submissions May Be Filed up to 180 Days before Market Authorization
In support of the Health Canada’s Regulatory Review of Drugs and Devices (R2D2) initiative and ... Read More
08
Mar2018
The PMPRB has released its March 2018 NEWSletter. This is the first NEWSletter posted by the PMPRB in several months.
While the details of the framework to modernize the PMPRB Guidelines remain to be worked out through consultation, its basic structure can be described as a risk-based approach to pricing review ... Read More
27
Feb2018
This afternoon Federal Finance Minister Bill Morneau unveiled his government’s third budget, focussing on a strong middle class, gender equality, indigenous reconciliation, and – as leaked yesterday upon the resignation of Ontario Health Minister Eric Hoskins – a new Advisory Council on the Implementation of National Pharmacare.
According to Budget 2018, ... Read More
23
Feb2018
On February 21, 2018, the Gazette officielle du Québec announced that draft regulations, relating to the implementation of fees for manufacturers submitting a scientific evaluation to the Institut national d’excellence en santé et en services sociaux (INESSS), have been submitted to the government of Québec for approval.
The fees will vary ... Read More
14
Feb2018
On February 13, 2018, the Canadian Agency for Drugs and Technologies in Health (CADTH) released a new CDR Update (Issue 133).
Revisions to CADTH’s Biosimilar Review Process In August 2017, CADTH issued a consultation to seek input on how biosimilar reviews could be enhanced in Canada. Based on the ... Read More
08
Feb2018
The pan-Canadian Pharmaceutical Alliance (pCPA) updated the status of negotiations on brand name drugs as of January 31, 2018:
35 negotiations are currently underway with 2 new files added since the last update of December 31, 2017:
Spinraza (nusinersen): Used to treat 5q Spinal Muscular Atrophy
Victoza (liraglutide): Used ... Read More
07
Feb2018
This is a reminder to patentees of their filing requirements respecting revenues and development expenditures. These filing requirements are contained in section 5 of the Patented Medicines Regulations.
All patentees must submit their Form 3 information for 2017 by March 1, 2018. Form 3, the template created by the PMPRB to ... Read More