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 ...
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 ...
NEW PDCI Report finds Health Canada significantly overstates benefits & underestimates negative impact of its proposed regulatory amendments
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...