In April 2026, Canada’s Drug Agency (CDA) released an expanded data set offering insights and trends within its regulatory system for drug approvals and reimbursement in Canada. This is an expansion from CDA’s original set of data, which was published in November 2025 and detailed drug submissions filed with Health Canada and CDA’s Drug Reimbursement Review program. The expanded data set includes insights on health technology assessment (HTA) timelines and covers 2020 to 2024.
In 2024, the expanded dataset showed that 111 drugs had received Health Canada approval. While this was an increase over the 106 drugs that received approval in 2023, it still represents a declining trend in the number of drugs being approved in Canada since 2020. In 2020, 150 drugs were approved in Canada, followed by 145 drugs in 2021 and 123 drugs in 2022, respectively. The number of drug approvals submitted to CDA for HTA reimbursement review remained fairly steady between 2020 and 2024, with an average of around 48.5% of new drug approvals being submitted to CDA for reimbursement review. Since 2020, there has been an increase in the number of manufacturers submitting to CDA for an HTA review, pre-Notice of Compliance (NOC) from Health Canada. The number of pre-NOC submissions to CDA increased steadily from 29 submissions in 2020 to 54 submissions in 2024, while the number of post-NOC submissions to CDA steadily declined from 32 submissions in 2020 to 22 submissions in 2024. Similarly, HTA recommendations by CDA were issued pre-NOC at an increasing number from 35 recommendations in 2020 to 52 recommendations in 2024. For CDA publishing recommendations post-NOC, there was a decline from 24 recommendations in 2020 to 20 recommendations in 2024. In 2024, 66% of the completed pre-NOC reviews were submissions that were filed with CDA at least 91 days in advance of regulatory approval. In 2024, 45% of post-NOC submissions were filed with CDA within 90 days of Health Canada approval and 30% of post-NOC submissions were submitted over one year after approval.
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From 2020 to 2024, CDA issued an increasing number of positive recommendations. In 2020, CDA issued 81% positive recommendations, compared to 94% in 2024. However, in 2020, CDA issued three reimburse-only recommendation types and 45 reimbursement with clinical criteria and/or conditions, whereas all positive recommendations in the years since have required a clinical criterion and/or condition. A time-limited reimbursement recommendation was issued for the first time in 2024. This is a new program launched by CDA to accelerate access to drugs for severe or rare diseases while manufacturers gather additional clinical data. Drugs that receive time-limited reimbursement recommendations will be reassessed at a later date, when the required data is submitted within a predetermined timeframe. While there has been an increasing trend of positive recommendations issued by CDA, all positive recommendations now require specific clinical criteria or price reduction conditions. These trends are further reflected in the figure below from GlobalData’s Price Intelligence (POLI), which shows the distribution of HTA outcomes from the CDA by year. Those outcomes are categorised as either positive (recommended) or neutral (recommended with restriction), representing evaluations that led to reimbursement while negative refers to exclusion from the reimbursement list. In 2024, the CDA delivered 37% more decisions compared to 2020.
Figure 1: Distribution of HTA decisions by latest decision year and outcome, Canada
HTA review timelines also improved over the five years. In 2020, 78% of HTA reviews were issued a draft recommendation within 180 days of acceptance for review, which steadily increased to 92% in 2024. The reviews that did not meet the 180-day deadline were due to suspensions, pending additional information, or based on CDA drug expert committee recommendations to delay the review post-NOC. For the overall HTA timeline, CDA also observed a decline in the median review time from submission to final recommendation. In 2020, the overall median HTA review time to final recommendation was 235 days, which decreased to 206 days in 2024, the shortest time in the five years.
According to GlobalData POLI, the average time to reimburse in Canada for all branded drugs has steadily increased. For branded medicines with a first reimbursement date in 2020, the average time from approval to reimbursement was 440 days, compared to 967 days for branded products with a first reimbursement date in 2024. While the data from CDA shows that reimbursement decisions were being made more quickly in 2024 compared to 2020, the time for drugs to reach reimbursement status in Canada has been increasing. This illustrates the complexities following a CDA review decision and the negotiations that manufacturers have to undergo with the pan-Canadian Pharmaceutical Alliance (pCPA). Even after successful pCPA negotiations, manufacturers still have to navigate individual government drug plans and agencies to determine the listing of drugs in their respective province or territory.
The CDA data provides transparency about the timelines and process of how long drugs are approved and granted reimbursement decisions in Canada. The country’s regulatory environment is known to be uniquely complex and difficult, with extensive HTAs and pricing negotiations required before public plans will list them. Pharma industry stakeholders will utilise this data to help inform their market strategy and on Canada’s HTA process. Thus, a pharma company can use the data to synchronise a global launch, allocate commercial resources appropriately, and scale its supply chain in alignment with regulatory timelines.
This article is produced as part of GlobalData’s Price Intelligence (POLI) service, the world’s leading resource for global pharmaceutical pricing, HTA and market access intelligence integrated with the broader epidemiology, disease, clinical trials and manufacturing expertise of GlobalData’s Pharmaceutical Intelligence Center. Our unparalleled team of in-house experts monitors P&R policy developments, outcomes and data analytics around the world every day to give our clients the edge by providing critical early warning signals and insights. For a demo or further information, please contact us here.
