JF

07

Feb2018

PMPRB Form 3 (R&D) Due Date Reminder

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

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 ... Read More

30

Jan2018

INESSS Releases Additional Information – Requests for Changes of an Administrative Nature

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

22

Jan2018

PMPRB myth busting (I): The imaginary link between Canadian price controls and R&D expenditures

The myth perpetuated by government and academics – and echoed in the media – is that the Patented Medicine Prices Review Board’s (PMPRB’s) current price control regime was somehow structured to go easy on patented drug prices in exchange for significant R&D commitments.  The upshot being that since the R&D ... Read More

15

Jan2018

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 December 31, 2017: 36 negotiations are currently underway with 5 new files added since the last update of November 30, 2017: Blincyto (blinatumomab) : Used to treat adult acute lymphoblastic leukemia Blincyto (blinatumomab) ... Read More

21

Dec2017

CADTH Common Drug Review Releases New Update

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

20

Dec2017

Happy Holidays from PDCI Market Access

14

Dec2017

TODAY at 1 pm: Government of Canada Officials to Speak on Proposed Regulatory Amendments

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.

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