Effective July 2, 2014, patient groups will now have 35 business days to prepare and submit their patient input submissions to CDR
This is possible due to the mandatory pre-submission advance notice policy which will be going into effect the same day. As per the policy, manufacturers must provide a minimum ... Read More
08
Jul2014
08
Jul2014
The Institut national d’excellence en santé et en services sociaux will have meetings with manufacturers who have submitted applications in advance of the deadline for the February 2015 Liste des médicaments update. Discussions will address clinical studies and economic and pharmacoeconomic aspects ... Read More
27
Jun2014
The Attorney General of Canada is appealing the May 27 decisions of Justice O’Reilly which concluded that generics firms marketing generic products (even under a licencing agreement from the patent holder) are not patentees for purposes of PMPRB price regulation so long as there is no monopoly (market exclusivity). See ... Read More
16
Jun2014
The Ministry of Health and Social Services has authorized the Institut National d’excellence en santé et en services sociaux (INESSS) (National Institute for Excellence in Health and Social Services) to issue 7 updates in 2015 to the Liste de médicaments. Updates will occur in February, March, April, June, July, October ... Read More
29
May2014
The Federal Court (Justice O’Reilly) issued decisions May 27 in two similar cases (Sandoz 2014 FC 501 and Ratiopharm 2014 FC 502) and concluded that generics firms that market generic products (even under a licencing agreement from the patent holder) are not patentees for purposes of PMPRB price regulation so ... Read More
27
May2014
On February 11, 2014, the pan-Canadian Oncology Drug Review (pCODR) invited stakeholder comments on proposed changes to the pCODR Procedures and related guidance documents.A summary of the stakeholder feedback can be found here.
In view of the stakeholder comments, effective June 1, 2014, pCODR will no longer ... Read More
26
May2014
CDR Consultation – Patient Input Template for Subsequent Entry Biologics (SEB)
CADTH has developed a patient input template for SEBs and is now seeking feedback on the proposed template.
Feedback should be emailed by June 6, 2014 to feedback@cadth.ca.
Temporary Suspension of a CDR Review Due to Incomplete Information
CADTH has recently encountered CDR submissions with ... Read More
25
May2014
Invitation to attend PMPRB Outreach sessions
Board Staff will be conducting training sessions regarding the online tool for the filing of the Form 2 information starting for the upcoming January to June 2014 filing.
The sessions will be given as follows:
Montreal: Wednesday June 11, 2014 from 1:00 p.m. to ... Read More
24
May2014
Common Drug Review (CDR) introduces new application fee for submissions
The Canadian Agency for Drugs and Technologies in Health (CADTH) is introducing an industry application fee for submissions made by drug manufacturers to CDR effective September 1, 2014 (April 1, 2015 for drugs submitted to the pan-Canadian Oncology Drug Review). All submissions with a ... Read More
23
May2014
Note worthy news featured in this edition include:
Anna Chodos and Beatrice Mullington retire
Final requirements for HDAP submissions
Online Filing of Form 2 - Project Update
CPI-Based Price-Adjustment Factors for 2015
The Hearing Panel approved a VCU in the Teva Canada Innovation G.P-S.E.N.C. and the medicine Copaxone matter
New Publication - NPDUIS Research ... Read More