Private: Gallery Post #1

05

May2022
On May 3, 2022, CADTH announced the mandate expansion of the Scientific Advice Program to include advice on RWE generation plans after protocols for pivotal trials are finalized. What to know: The expanded program will run for a 1-year learning ... Read More

25

Apr2022
On April 14, 2022, Health Canada announced that the government will:  Proceed only with the proposed amendments to the Regulations pertaining to schedule of reference countries (the PMPRB11 replacing the PMPRB7).   Not proceed with new excessive price factors (cost effectiveness, market size, GDP) nor the reporting of third-party ... Read More

11

Apr2022
The Canadian Agency for Drugs and Technologies in Health (CADTH) has published Issue 28 of its Pharmaceutical Reviews Update. Below PDCI has summarized the updates and clarifications, and provided implications for manufacturers. CADTH’s update also includes two consultations open until April 14, one concerning a streamlined drug class ... Read More

04

Apr2022
On March 31, 2022, PMPRB published its 2020 Annual Report on its website. Key statistics reinforce concerns about Canada’s continued attractiveness for new medicine investment and launch since drug pricing reform began in 2017. Statistical Highlights201820192020Total # of Patented Medicines for Human Use Reported ... Read More

25

Mar2022
On September 29, 2021, the Attorney General of Canada applied for leave to appeal to the Supreme Court of Canada concerning the Federal Court of Appeal’s (FCA) July 2021 decision in Alexion Pharmaceuticals Inc v Canada (Attorney General). On March 24, 2022, the Supreme Court of Canada ... Read More

22

Feb2022
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
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
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
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 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