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.
Following the December 2, 2017 publication of proposed amendments to the Patented Medicines Regulations in Canada Gazette Part I, and the corresponding publication of the Regulatory Impact Assessment Statement, PMPRB has published a Guidelines Scoping Paper providing “…an outline of the PMPRB’s preliminary thoughts on how best to operationalize ... Read More
The pan-Canadian Pharmaceutical Alliance (pCPA) updated the status of negotiations on brand name drugs as of November 30, 2017:
39 negotiations are currently underway with 4 new files added since the last update of October 31, 2017:
Cerdelga (eliglustat): Used to treat Gaucher disease
Cerezyme (imiglucerase): Used to treat ... Read More
The mandatory public consultation process must be a tiresome inconvenience for Health Canada policy makers. At least that’s the perception from the release of its proposed amendments to the Patented Medicines Regulations (Regulations) and the accompanying Regulatory Impact Assessment Statement (RIAS) published in Canada Gazette Part I last week. Why ... Read More
Join us for a webinar on Dec 06, 2017 at 2:00 PM EST.
Register now!
Join PDCI’s Founder and Principal Consultant, Neil Palmer on this industry only webinar as he discusses the proposed amendments to the Patented Medicines Regulations as published in Canada Gazette Part 1 on December 2, 2017. What ... Read More
On December 1, 2017, Manitoba Health, Seniors and Active Living released a notice announcing a number of updates to their product submission criteria (last updated in 2007) to consider requirements introduced since 2007 including:
requirement to complete pan-Canadian Pharmaceutical Alliance (pCPA) negotiations for brand products;
the pCPA Centralized Price Confirmation ... Read More
Proposed regulatory text of amendments to the Patented Medicines Regulations is published by the Governor-in-Council in Canada Gazette Part I (CG1) on December 2, 2017. Interested persons may submit comments on the proposed regulations within 75 days of publication in CG1 (by ... Read More
On November 28, 2017, Québec’s Institut national d’excellence en santé et en services sociaux (INESSS) released a notice to manufacturers announcing further details on the continuous evaluation process.
Effective today, INESSS is initiating the consultation period for drug products for which a listing request was filed between October 2, 2017 and ... Read More
PMPRB reporting season has been a semi-annual event for Canadian patentees for more than two decades. The mandatory reporting provides necessary information for PMPRB to fulfill its mandate: both to ensure patented drug prices are not excessive relative to those in other comparable jurisdictions, and to report to Parliament on ... Read More
On November 27, 2017, the Canadian Agency for Drugs and Technologies in Health (CADTH) released a new CDR Update (Issue 131)
Collaborative Workspaces: Revised Process for Filing CDR Submissions and Resubmissions
The CADTH Common Drug Review (CDR) is aligning the process for secure file sharing with the ... Read More
