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
08
Mar2018
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
01
Feb2018
On January 29, 2018, PDCI released a report critically evaluating Health Canada’s plan to change how patented medicine prices are regulated in Canada.
PDCI’s report - entitled Proposed Amendments to the Patented Medicines Regulations: A Critical Appraisal of the Cost-Benefit Analysis – includes perspectives on the Regulatory Impact Assessment Statement ... Read More
30
Jan2018
On January 29, 2018, Québec’s Institut national d’excellence en santé et en services sociaux (INESSS) released a notice to manufacturers. This notice is a supplement to the information published on August 18, 2017 regarding changes of an administrative nature.
Requests for withdrawals from the Liste des médicaments and the Liste des ... Read More
21
Dec2017
On December 12, 2017, the Canadian Agency for Drugs and Technologies in Health (CADTH) released a new CDR Update (Issue 132).
Update on Revised Process for Biosimilars
In August 2017, CADTH invited stakeholder comments and feedback on a proposal to revise the submission and review process for biosimilars through ... Read More
14
Dec2017
Government of Canada officials will hold a bilingual web-based information session about the proposed regulatory amendments. See the Government of Canada announcement for details on today’s webinar.