The PMPRB has announced the 2020 meeting dates to the Human Drug Advisory Panel (HDAP)’s , releasing a total of four (4) dates, as per previous years.
This corrected version of TargetPharma makes a distinction between the deadline for submitting the Product Monograph and the deadline for the Patentee's submission.... Read More
19
Aug2019
09
Aug2019
PMPRB and Health Canada held two technical briefings on the soon-to-be published final amendments to the Patented Medicines Regulations (PMR) on August 9th, 2019. This coincided with the pre-release of the final regulatory text and an updated Regulatory Impact Analysis Statement (RIAS). Publication in Canada Gazette II is expected August ... Read More
18
Jun2019
Effective June 14, 2019, Mélanie Bourassa Forcier is Vice-Chairperson of the Patented Medicine Prices Review Board (PMPRB)
Professor Bourassa Forcier is an Associate Professor in the Faculty of Law at the Université de Sherbrooke, and directs the Law and Health Policy, and Law and Life Sciences programs. ... Read More
14
Jun2019
Mark down June 26th, 2019 in your calendars.
It is now widely expected the patented medicines price regulations will be in Canada Gazette Part II (CGII), volume 151 No.13, which will be released on June 26th. Draft PMPRB Guidelines for consultation will likely be published immediately following CGII publication. Comments earlier this week from Federal Health Minister Petitpas-Taylor, appeared to confirm these expectations. When asked in an interview surrounding when changes to the ... Read More
27
Aug2018
PMPRB published its 2017 annual report this week, recalling an eventful year (complete with proposed amendments to its overarching regulations, poised to fundamentally change its future mandate & operations) and looking forward in 2018 to working constructively with stakeholders to finalize its Guidelines modernization initiative, underway since 2016.
PMPRB 2017 Annual ... Read More
11
May2018
PMPRB has released its May 2018 NEWSletter which includes anticipated updates on PMPRB’s timelines for its Guidelines modernization initiative:
June 2018:
PMPRB to release more specific guidance on how the PMPRB foresees operationalizing regulatory changes
PMPRB to form a multi-stakeholder Working Group to gather input on key technical aspects of ... Read More
08
Mar2018
The PMPRB has released its March 2018 NEWSletter. This is the first NEWSletter posted by the PMPRB in several months.
While the details of the framework to modernize the PMPRB Guidelines remain to be worked out through consultation, its basic structure can be described as a risk-based approach to pricing review ... Read More
07
Feb2018
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
11
Dec2017
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
04
Dec2017
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