PMPRB NEWSletter: January 2026, Volume 30, Issue 1

Message from the Acting Chairperson

I hope you had a wonderful holiday season, filled with moments of joy and rest with your loved ones. 

2025 was a particularly busy for the PMPRB, and this year promises to be just as demanding, including with the implementation of the new Guidelines. Before discussing what’s to come  in 2026, I would like to lookback on the highlights of 2025, a year marked by sustained activity within our organization.

Although the publication of the Guidelines for PMPRB Staff was the most significant event of 2025, the PMPRB also worked on several other important files. Notably, our teams held important meetings with stakeholders and various interested parties to prepare them for the implementation of these Guidelines. We have also written a new Code of Conduct for Board members, started reviewing thoroughly our hearing processes to ensure efficient and modern hearings, and published our 2026–2030 Strategic Plan last November.  As you know, the PMPRB is also an important source for pharmaceutical information. We published our 2024 Annual Report where we track our price monitoring and trends in the pharmaceutical market for the last year, as well as reports to the Minister of Health on pricing, utilization, and cost trends such as CompassRx.   

So, what does 2026 have in store for us? A bright and productive future, as described in our 2026-2030 Strategic Plan. By establishing our priorities for the next five years, we are confident that we will be able to carry out our mandate while upholding our guiding principles, namely credibility, excellence, engagement, collaboration, and transparent communication.

In addition to continuing the modernization of our hearing processes and to conducting a public consultation on this matter — so that the PMPRB will be fully prepared for its next hearing — the Policy and Economic Analysis Branch team is in the process of publishing the upcoming editions of Meds Pipeline Monitor, Meds Entry Watch, and Generics360. Conversation will also be continued with our national and international partners on pricing and reimbursement issues. Finally, 2026 will be marked by the publication of a new report monitoring the pipeline in Canada, a critical issue for Canadians.  

As you can see, there is still much to be done by the PMPRB staff. The Board members and I are starting the year with a firm commitment to continue our primary mission: protecting Canadians by monitoring the prices of patented medicines sold in Canada by rights holders to ensure that those prices are not excessive.

I wish you all a successful 2026.

Sincerely,

Preparing for the Implementation of the 2025 Guidelines for PMPRB Staff

The PMPRB has been actively preparing for the implementation of the 2025 Guidelines.

Information Sessions

On November 17 and 18, 2025, the PMRPB hosted information sessions to provide an overview of the changes to the Guidelines. This was also the opportunity for Rights Holders and other stakeholders to ask questions on technical details of the implementation. The presentation is available to review on the PMPRB website.

Website Updates

Since the publication of the Guidelines, the PMPRB website was updated with information for Rights Holders to support a smooth transition to the new framework.

• The Review Process page summarizes the steps in the new Guidelines, along with information on timelines.
• The Complaints page has been updated to reflect the new information on how to submit a complaint. 
• The Rights Holder Input Relating to the Scientific Review Process page has been updated to provide details on the suggested approach for submissions along with requirements for filing electronic submissions.

Moving Forward

Please note that the semi-annual submission process remains unchanged, and the next filing, covering the period of July 1 to December 31, 2025, is due no later than January 30, 2026. Rights Holders should have received a communication specific to their upcoming filing in December 2025. Information on the filing requirements and deadlines can be found on the Filing Data to the PMPRB page. Rights Holders are reminded that Block 5 information should always be filed with the most up-to-date information, regardless of the volume of sales.

For this filing period, PMPRB Staff will only conduct an initial review of medicines considered “new” under the 2025 Guidelines—meaning those with a first date of sale on or after July 1, 2022. Rights Holders can expect to be notified of the outcome by end of March 2026 through a letter that will also include an Information Report for their “Existing medicines”.

Until then, questions on the upcoming filing can be sent to PMPRB.Filing-Depot.CEPMB@pmprb-cepmb.gc.ca. General questions on the implementation of the new framework can be sent to PMPRB.Information-Renseignements.CEPMB@pmprb-cepmb.gc.ca.

Strategic Plan 2026–2030

The PMPRB published the 2026–2030 Strategic Plan in November, 2025.

The Strategic Plan lays out the PMPRB’s core guiding principles as an organization - credibility, excellence, engagement, collaboration, and transparent communication.

The plan also describes the PMPRB’s four commitments for 2026 to 2030 and the strategies to accomplish them, which come directly from our mandate and the needs of our environment. 

The 2026–2030 Strategic Plan is available on the PMPRB website.

Events

The PMPRB participated in the following events:

• September 9, 2025 – Director General, Guillaume Couillard, delivered a presentation to the Canadian Association of Professionals in Regulatory Affairs in Toronto
• September 11, 2025 – Director General, Guillaume Couillard, participated in the Canada Drug Agency System Coordination & Alignment Federal, Provincial, and Territorial Government Meeting in Toronto
• September 23, 2025 – Director General, Guillaume Couillard, delivered a presentation to the Canadian Association of Professionals in Regulatory Affairs in Montreal
• September 26, 2025 – Director General, Guillaume Couillard, attended a Canada Drug Agency workshop in Toronto
• September 26, 2025 – A Board Meeting was held in Ottawa
• October 1, 2025 – Acting Chairperson, Anie Perrault, and Director General, Guillaume Couillard, held a meeting with INESSS in Montreal
• October 28 & 29, 2025 – Acting Chairperson, Anie Perrault, and Director General, Guillaume Couillard, presented and participated at the Market Access Summit in Toronto
• November 25, 2025 – Director General, Guillaume Couillard, spoke at the Canadian Organization for Rare Disorders conference in Ottawa
• December 3, 2025 – Acting Chairperson, Anie Perrault, presented at the Canadian Association for Healthcare Reimbursement National Day in Ottawa

NPDUIS Research Initiative Activities

The PMPRB continues to publish a number of analytical studies for the Minister of Health through the NPDUIS research initiative. In addition, the PMPRB hosted information sessions to share the results of its recent reporting.

NPDUIS Advisory Committee Meeting

The NPDUIS Advisory Committee reconvened virtually in June and October 2025 for quarterly meetings led by PMPRB and Canadian Institute for Health Information (CIHI) representatives. The NPDUIS Advisory Committee advises and supports the PMPRB on research priorities, the development of research methodologies, and the interpretation of analytical results. It is composed of public drug plan representatives and participants from Health Canada, CIHI, Canada’s Drug Agency (CDA-AMC) and the pan-Canadian Pharmaceutical Alliance (pCPA) Office.

The Committee will reconvene for its next meeting in winter 2026.

Conference Participation

NPDUIS research initiative analysts were invited to present research briefs at the following conferences:

• International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2025 Conference in Montreal, QC (May 13-15, 2025)
• Canadian Association for Health Services and Policy Research (CAHSPR) 2025 Conference in Ottawa, ON (May 26-29, 2025)
• Canadian Association for Population Therapeutics (CAPT) 2025 Conference in Toronto, ON (September 22-23, 2025)

NPDUIS Research Initiative: New and Upcoming Publications

New Releases

Reports

CompassRx, 10^th Edition: Annual Public Drug Plan Expenditure Report, 2022/23

The PMPRB’s flagship CompassRx report monitors and analyzes the cost pressures driving changes in prescription drug expenditures in Canadian public drug plans. The tenth edition of the report provides insight into the factors driving growth in drug and dispensing costs in 2022/23, as well as a retrospective review of recent trends in public drug plan costs and utilization.

Information sessions on the main the findings of CompassRx, 10^th Edition were held on October 29 and 30, 2025.

Meds Entry Watch, 9^th Edition  

The Meds Entry Watch report series explores the market entry of new international approvals from a Canadian lens. Building on a retrospective analysis of trends since 2018, this report focuses on medicines that received first-time approval from the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and/or Health Canada in 2022 and 2023, and analyzes their uptake, pricing, sales, and availability as of the last quarter of 2023 (Q4-2023). In addition to the international analysis, a Canadian-focused section provides sales and pricing information on medicines that received their first Health Canada approval in 2022, as well as a retrospective review of approvals from 2019 to 2023.

Information sessions on the main findings of Meds Entry Watch, 9^th Edition were held on June 25 and 26, 2025.

Research Briefs

The following research briefs, summarizing projects presented by PMPRB staff at various conferences and symposia, are now available:

• Biosimilars in Canada: Policies to Promote Switching and What It Means for Payers
• Canada’s evolving market for biosimilars and what it means for payers
• Canadian generic market trends and international comparison, 2018–2024
• Drug shortages in focus: Why competition is key
• Factors delaying the public listing of drugs in Canada
• Insight into approvals, marketing, and pricing of new medicines, 2018 to 2023             
• Navigating the market landscape for rare disease drugs in Canada
• Pressures behind the rising costs in Canadian private drug plans pre- and post- COVID-19 pandemic: 2018–2023       
• Trends in the global drug development pipeline, 2021–2025

Coming Soon

Several studies are slated for publication in the coming months:

Meds Pipeline Monitor 2026

The Meds Pipeline Monitor (MPM) is a horizon-scanning report series that features a selection of new medicines in the late stages of clinical evaluation that may have a significant impact on future clinical practice and drug spending in Canada. The 2026 edition will identify a broad range of late-stage medicines in the pipeline and review those featured in the previous edition of the MPM to report on changes to their status in the pipeline. A section focused on Canada will highlight potentially significant medicines currently under review by Health Canada.

Meds Entry Watch, 10th Edition

The Meds Entry Watch report series explores the market entry of new international approvals from a Canadian lens. Building on a retrospective analysis of trends since 2021, the tenth edition will focus on medicines that received first-time approval from the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and/or Health Canada from 2021 through 2025, and analyze their uptake, pricing, sales, and availability as of the last quarter of 2024 (Q4-2024) . In addition to the international analysis, a Canadian-focused section will provide trend analysis of  sales and pricing information on medicines that received their first Health Canada approval from 2021 to 2025.

Generics360

Generics360 reports on the latest trends in the Canadian generic drug market within an international context. Canada has established one of the strongest generic markets in the industrialized world, though domestic prices have historically been much higher than international levels. To inform policy discussions and support evidence-based decision making, the PMPRB has been monitoring changes in the generic landscape in Canada since 2007. Building on these previous analyses, future editions of Generics360 will review the decades-long impact of generic pricing policies in Canada.