Private: Gallery Post #1

22

Feb2022

Quebec Court Strikes 2 of 3 PMPRB Changes

On February 18, 2022, the Quebec Court of Appeal ruled that two of the three major proposed changes to the PMPRB price regulations are unconstitutional: As more information becomes available, PDCI will share further insights and implications for ... Read More

14

Feb2022

Reminder: Form 3 filing is due to the PMPRB On March 1, 2022

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. The Annual Form 3 filing to the PMPRB is due on March 1, 2022. As ... Read More

31

Jan2022

Updates to the Ontario Guidelines for Drug Submission and Evaluation

The Ontario Ministry of Health has recently updated the Ontario Guidelines for Drug Submission and Evaluation (Guidelines). In an effort to reduce complexity and simplify their policy document, specific guidelines aiming to address individual product types are now available on the Ontario Ministry of Health website.... Read More

17

Dec2021

PMPRB Proposed Amendments to the July 1, 2021 Guidelines

On October 28th, 2021, PMPRB provided their first update to the Notice & Comment that was issued on July 15, 2021. The primary takeaway is PMPRB will be providing patentees two reporting periods for compliance, a change from PMPRB's earlier position expecting one reporting period for ... Read More

17

Dec2021

Consultation Notice: Proposed Framework for a Potential Pan-Canadian Formulary

Consultation on the Proposed Framework for a Potential Pan-Canadian Formulary will be open for feedback from January 11 - February 25, 2022.  A discussion paper summarizing the Advisory Panel’s interim recommendations and proposed process will be posted on the CADTH website and CADTH will host an information session on January 18, 2022 at 1 p.m. (ET).  ... Read More

17

Dec2021

CADTH Pharmaceutical Reviews Update- Issue 27

On December 16, 2021, CADTH provided an update regarding CADTH’s drug review programs. A. Expanded Provisional Funding Algorithm Process CADTH has expanded the provisional funding algorithm process to include a new rapid algorithm process. This rapid algorithm process will be ... Read More

29

Jun2021

Patented Medicines Regulations/PMPRB Guidelines Further Delayed Until January 1, 2022

This morning, June 29th, 2021, Health Canada announced an additional 6-month delay in implementation of the Patented Medicines Regulations and Final PMPRB Guidelines.  The changes will now come into force on January 1, 2022. The reasons cited by Health Canada for the delay are the ongoing COVID-19 pandemic and need ... Read More

14

Jun2021

Save the Date! PMPRB has Released Upcoming Webinar on June 15th

Information regarding the PMPRB guidelines and the upcoming webinar can be found here. Registration is required to attend the webinar and can be completed here. Online Filing Tool & Transition Measures for Grandfathered and Gap MedicinesDate: Tuesday June 15th, 2021Time: 1:30-3:30pm For inquiries on ... Read More

20

May2021

PDCI at ISPOR: Poster Presentation on Oncology Companion Diagnostics

ISPOR 2021 runs between May 17-20 with the theme of HEOR: Evolving for Tomorrow's Challenges. During the conference, PDCI Market Access will be presenting a poster titled: Identification of Gaps and Opportunities for Provincial Reimbursement of Oncology Companion Diagnostics in Canada on May 18th 2021 from 11:30:00 AM ... Read More

06

May2021

PMPRB Announces the Guideline Monitoring and Evaluation Plan (GMEP) Consultation

The PMPRB is developing a Guideline Monitoring and Evaluation Plan (GMEP) that will analyze trends in the pharmaceutical market before and after the implementation of the new framework to assess whether it is working as intended, and to inform the need for any future adjustments. The PMPRB ... Read More