Private: Gallery Post #1

11

Dec2017

PMPRB Releases Guidelines Scoping Paper with Overview of Potential New Framework

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

07

Dec2017

The pan-Canadian Pharmaceutical Alliance (pCPA): Negotiations Status Update

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

04

Dec2017

PDCI Webinar: Proposed Amendments to Patented Medicines Regulations – What Patentees Need to Know

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

04

Dec2017

Manitoba Health Amends Submission Requirements

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

01

Dec2017

Proposed Amendments to Patented Medicines Regulations Announced

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

29

Nov2017

INESSS Releases Additional Information on the Continuous Evaluation Process

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

28

Nov2017

CADTH Common Drug Review Releases New Update

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

27

Nov2017

2017 Québec City Healthcare Industry Forum

Join PDCI Market Access Inc.’s Nancy Paul Roc and Carla Freige at Québec’s International 11th edition of the Québec City Healthcare Industry Forum held on December 5 and 6, 2017 at the Hilton Québec. As in previous editions, the 2017 Québec City Healthcare Industry Forum will spark discussions between stakeholders in ... Read More

16

Nov2017

INESSS Releases Additional Information on the Continuous Evaluation Process

On November 13, 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. As of December 1, 2017, manufacturers can submit an application for registration to INESSS for a new innovative drug product or a ... Read More

16

Nov2017

CADTH Common Drug Review Releases New Update

On November 13, 2017, the Canadian Agency for Drugs and Technologies in Health (CADTH) released a new CDR Update (Issue 130). Revised Procedure for the CADTH Common Drug Review Resubmissions In August 2017, CADTH invited stakeholder comments and feedback on a proposal to revise the resubmission requirements for its Common ... Read More