Private: Gallery Post #1

23

Feb2018

Québec Gazette Announces Draft Regulations for Implementation of Fees for INESSS Submissions

On February 21, 2018, the Gazette officielle du Québec announced that draft regulations, relating to the implementation of fees for manufacturers submitting a scientific evaluation to the Institut national d’excellence en santé et en services sociaux (INESSS), have been submitted to the government of Québec for approval. The fees will vary ... Read More

14

Feb2018

CADTH Common Drug Review Releases New Update

On February 13, 2018, the Canadian Agency for Drugs and Technologies in Health (CADTH) released a new CDR Update (Issue 133). Revisions to CADTH’s Biosimilar Review Process In August 2017, CADTH issued a consultation to seek input on how biosimilar reviews could be enhanced in Canada. Based on the ... Read More

08

Feb2018

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 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 ... Read More

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

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

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