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


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


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


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


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


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


The Patented Medicine Prices Review Board (PMPRB), in accordance with sections 89 and 100 of the Patent Act, released its Annual Report for the year ended December 31, 2016. The Annual Report is an extensive document that reviews all of the PMPRB’s major activities, analyses of the prices of patented ... Read More


The Hearing Panel of the Patented Medicine Prices Review Board has made public its decision in the matter of Alexion Pharmaceuticals Inc. and the medicine Soliris. The Panel orders Alexion to: pay to Her Majesty in right of Canada an amount calculated by the parties in accordance with Schedule ... Read More


PDCI has now published its information sharing webpage which aggregates submissions made by individuals and organizations in response to Health Canada’s Consultation on Proposed Amendments to the Patented Medicines Regulations. Click Here to Visit PDCI’s Information Sharing Webpage. The submissions have been provided by individuals & organizations on a completely voluntary ... Read More


***Participation Requested*** Sharing Responses to Health Canada’s Consultation on Proposed Amendments to the Patented Medicines Regulations In May 2017, Federal Minister of Health Jane Philpott, launched a consultation on proposed amendments to the Patented Medicines Regulations that would have significant effects on how patented ... Read More