Health Canada’s Solutions for Faster Drug Approval
July 22, 2025
How they work and how they’re working
Part of our universal health system’s mandate is to deliver high-value drugs to patients as quickly as possible, and Health Canada has well-established tools to make this happen. But with the heightened need for timely access noted at the 2024 Council of the Federation Fall Meeting,1 along with many high-priority drugs flooding the global pipeline, old questions have taken on new urgency: Are we making full use of the pathways in place? Are there further opportunities to accelerate patient access to novel therapies? Can international initiatives spur Canada to up its access game?
Answering these questions requires an understanding of the regulatory mechanisms that underpin accelerated drug reviews in Canada, namely Priority Review and Notice of Compliance with Conditions (NOC/c). Here, we deconstruct these pathways and examine how they intersect with Project Orbis, an international collaboration that seeks to speed up access to promising treatments to cancer patients across the globe.2 We also investigate how Canadian stakeholders are evolving their approach to certain regulatory files, and how it might help shape the future of accelerated access in Canada.
HEALTH CANADA’S BUILDING BLOCKS
Priority Review
Health Canada’s Priority Review, Canada’s well-established “fast lane,” facilitates accelerated access to new drugs or new drug indications that address an unmet need. The process dates back to 1996, when a policy statement called Priority Review of Drug Submissions first took shape.3 In an updated guidance document for industry, Health Canada specifies that the policy applies to drugs that 1) have substantial evidence of efficacy for treating or preventing a condition for which no drug currently exists in Canada, or 2) significantly improve on the risk/benefit profile of existing medications for the condition.3 As part of the submission package, manufacturers must include clinical data to support the claim of efficacy (or better efficacy than existing options), including the status of ongoing trials.
Upon receipt of Priority Review status, the manufacturer must file the submission within 60 days, and the government has set a target of 180 days to review the submission (in contrast to the regular review benchmark of 300 days).3
Health Canada has authorized a wide range of new treatments under the Priority Review umbrella – a total of 20 just in 2024.4 Earlier examples include OPDIVO, used to treat certain types of melanoma, ENTRESTO, for heart failure in adults, and CARBAGLU, which helps maintain blood ammonia at a normal level in people missing a specific liver enzyme.5
Notice of compliance with conditions
The Advance Consideration for Notice of Compliance with Conditions (NOC/c) policy, first introduced in 1998 and revised on several occasions, seeks to provide access to promising new drugs and create mechanisms for establishing the clinical benefit of these drugs.6
While designed to approve rare, life-threatening diseases with no treatment available, “we see the NOC/c pathway being used most often for the abundance of targeted oncology therapies,” says Dr. Catherine Lau, a pharmaceutical regulatory expert and former president of the Canadian Society of Pharmaceutical Sciences. In fact, “NOC/c now surpasses regular NOC approvals for this category.”
“The NOC/c pathway has become widely used for targeted oncology therapies. In fact, the NOC/c pathway now surpasses regular NOC approvals for this category.”
Dr. Catherine Lau
The types of drugs eligible for this framework overlap tightly with those that qualify for Priority Review. What sets the two pathways apart is the level of evidence supporting the candidate drugs: Health Canada may grant NOC/c on the basis of promising rather than established clinical evidence, providing the drug meets acceptable safety criteria and product quality standards. Before receiving NOC/c authorization, the sponsor (drug developer) must specify the studies it intends to carry out to confirm the drug’s clinical benefit. (Of note: while Priority Review and advance consideration for NOC/c represent distinct pathways, Priority Review may culminate in NOC/c if the regulator deems that more confirmatory evidence is needed.6,7).
Another point of difference: Priority Review almost always results in a positive HTA recommendation, because “the confirmatory Phase 3 evidence is already there,” says Dr. Lau. In contrast, NOC/c approvals “carry a high level of uncertainty, which translates to a high proportion of negative reimbursement decisions.”8
Priority Review vs. NOC/c: Similarities and Differences3,6
|
Priority Review |
NOC/c |
|
| Intended use |
Serious, life-threatening, or severely debilitating conditions |
Serious, life-threatening, or severely debilitating conditions |
| Required evidence |
Substantial evidence of clinical efficacy (Phase III data) |
Promising evidence of clinical efficacy (typically Phase II data) |
| Approval endpoint |
Full (NOC) or conditional (NOC/c) |
Conditional (NOC/c) |
| Target review time |
180 days |
200 days |
All told, 19% of drugs approved by Health Canada in 2024 went through either the Priority Review or NOC/c pathway.4 That’s almost one in 5 – a healthy amount of traffic for these high-speed avenues.
Project Orbis
Most recently, Canada has folded a global regulatory collaborative model called Project Orbis into its accelerated and standard drug approval processes. A brainchild of the FDA Oncology Center of Excellence, Project Orbis launched in 2019 with a focus on high impact, advanced cancer therapies.9 International partners such as Canada, Australia, New Zealand, Brazil, and Switzerland soon joined the project. The initiative embodies the idea that collaboration among international regulators can speed up access to cancer treatments in countries with extensive regulatory bottlenecks.
The FDA, Health Canada, and the Australian Therapeutic Goods Administration took part in the first Project Orbis joint drug review, involving a combination treatment (LENVIMA + KEYTRUDA), for advanced endometrial cancer.9 The effort culminated in regulatory approval in all three countries, although the Canadian indication differed slightly from the one in the US and Australia. The project has gathered considerable steam since that time: as of the end of 2024, 111 drugs have received regulatory approval via Project Orbis worldwide, of which 74 got approved in Canada.2,4
Number of Health Canada approvals reviewed through Project Orbis, by year2,4,9
For Health Canada, Orbis offers a way to collaborate with peer regulators and to access a broader evidence base. For manufacturers, it’s a mechanism for harmonizing regulatory submissions across jurisdictions. It also encourages multinational pharmaceutical companies to include Canada in their early marketing targets, rather than waiting until they have launched in mega-markets such as the US and the EU. Project Orbis drugs also tend to reach Canadian patients slightly quicker after regulatory approval, with a mean time of 530 days from NOC to first provincial listing – a touch less than the 598-day figure for Canadian drugs as a whole reported in 2024.10
That said, Project Orbis doesn’t guarantee an accelerated timeline. As Dr. Jian Wang, a recently retired Health Canada veteran and expert in advanced biological cancer therapy regulations, explains, “Project Orbis is a platform for international regulatory review collaboration – in other words, a tool. A drug does not acquire special priority status at Health Canada by appearing on the Orbis list.” If an Orbis drug is deemed suitable for Priority Review or NOC/c, it can enter these pathways like all other candidate drugs. As Dr. Wang puts it, “a priority is a priority; advance consideration is advance consideration. It doesn’t matter if it’s Orbis or not.”
“Project Orbis is a platform for international regulatory review collaboration. A drug does not acquire special priority status at Health Canada by appearing on the Orbis list.”
Dr. Jian Wang
Health Canada Scientist Emeritus [recently retired]
A LINK TO FASTER LISTING?
Approval, however, does not always dovetail smoothly with patient access. In December 2024, Canada’s premiers announced their intent to pilot a project to cut access time to a short list of drugs by 9 months.11 Their proposed framework, covering 7 to 10 cancer drugs approved annually through Project Orbis, would list these drugs in public plans as soon as they receive a positive health technology recommendation from Canada’s Drug Agency (CDA-AMC), with temporary agreements in place during pricing negotiations with the Pan-Canadian Pharmaceutical Alliance (pCPA). As per the announcement, this parallel process would save patients the 9 months currently devoted to the price-setting process.
Innovative Medicines Canada lauded the proposal, describing it as “a critical step toward closing access gaps that can arise immediately following a positive recommendation by Canada’s Drug Agency.”1 Some experts, however, have ascribed the access bottleneck to pharmaceutical companies, who choose when to submit drugs for approval and may put a lower priority on smaller market players such as Canada.12 Others have pointed to the need for more resources to support Priority Reviews.
Half a year after the premiers’ announcement, rather than wait out the reported “jurisdictional concerns” that stalled the original pan-Canadian proposal, Ontario decided to forge ahead on its own. In May 2025, the province announced its intent to proceed with a 3-year pilot project combining the negotiation and listing stages for the selected Project Orbis drugs12 – a file to watch closely as the implementation details play out in the coming months.
There’s movement toward faster access in the rest of the country, too – notably through prioritization and acceleration of process flows. INESSS, Quebec’s HTA body, gives precedence to files considered high priority by Health Canada, namely NOC/c and Priority Review files, including Project Orbis.13 On a national level, the pCPA has been working to reduce its contribution to the access logjam, recently announcing a drop in pricing negotiation times for oncology drugs – from 9 months in 2020 to 5 months in 2024, the shortest timeframe ever.14
Case study: timely TAGRISSO access in the UK15
Globally, several jurisdictions have linked Project Orbis approvals to faster public access. The UK, for example, has incorporated Orbis timelines into its managed access agreement pathways. Take the lung cancer drug TAGRISSO, approved in the UK (and elsewhere) under Project Orbis in May 2021. It’s what happened after approval that illustrates the power of integrating approval and access. That same month, the NHS listed the drug on its formulary and made it available to patients. At the same time, the drug went through the regular HTA review processes. This parallel framework enabled patients to access TAGRISSO during the interval between MRHA approval and NICE’s final positive HTA recommendation.
THINKING CANADIAN
While Project Orbis promises access efficiencies, its use in Canada raises an important question: While leaning on an international pathway like Orbis is one approach, could we also be maximizing the Canadian tools already at our disposal?
Priority Review and NOC/c, our home-grown regulatory tools, have already demonstrated their capacity to accelerate drug approval reviews – with the advantage of aligning with Canadian health priorities and regulatory standards. While there’s nothing inherently wrong with adopting international tools such as Orbis, integrating them with existing pathways would multiply their value – an opportunity not to be missed.
As the provinces build new drug access frameworks, they could also work on integrating these processes with accelerated reviews and approvals. Whether an approval arrives via Priority Review, NOC/c, and/or Project Orbis, such synchronization would create a more consistent access environment for manufacturers and patients alike.
With the Ontario Orbis pilot gaining momentum and new provincial commitments on the table, Canada has taken exciting steps toward accelerated drug approval and access. Let’s keep this momentum going with a Canada-first approach. When it comes to bringing life-saving therapies to patients faster, Canadians deserve a Canadian solution.
References
1. Press Release. Dec. 16, 2024. Innovative Medicines Canada. https://innovativemedicines.ca/newsroom/all-news/innovative-medicines-canada-applauds-premiers-agreement-at-2024-council-of-the-federation-meeting-to-accelerate-access-to-life-saving-medications/
2. Project Orbis. Government of Canada. https://www.canada.ca/en/health-canada/services/drugs-health-products/international-activities/project-orbis.html
3. Guidance for industry : Priority Review of drug submissions. Health Canada. https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/priordr-eng.pdf
4. 20Sense original research.
5. Health Canada new drug authorizations : 2015 highlights. https://publications.gc.ca/collections/collection_2018/sc-hc/H161-9-2015-eng.pdf
6. Guidance document : notice of compliance with conditions (NOC/c). Health Canada. https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/pdf/prodpharma/applic-demande/guide-ld/compli-conform/noccg_accd-eng.pdf
7. Priority Review vs NOC/c – Which Pathway is Right for Me? Intrinsik. Nov. 18, 2021. https://intrinsik.com/priority-review-vs-nocc-pathway-right/
8. Lau CY, Rawson NSB. Curr. Oncol 2024;31:5599.
9. Project Orbis. US Food & Drug Administration. https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis
10. IQVIA Market Access Metrics, December 2024.
11. Council of the Federation Fall Meeting, closing news conference. Dec. 16, 2024. https://www.youtube.com/live/Ln2weDvQzxg
12. Rushowy K. Ontario government aims to fast-track cancer drugs in new pilot project. Toronto Star. May 13, 2025. https://www.thestar.com/politics/ontario-government-aims-to-fast-track-cancer-drugs-in-new-pilot-project/article_26521f84-e246-4577-a5bd-e968506b9050.html
13. INESSS: Aligning Market Access Strategies with Pharmaceutical Reviews in Quebec. Pathways To Access & Reimbursement forum. March 27, 2025.
14. Cancer drugs being negotiated faster than ever. pCPA news release. May 22, 2025. https://www.pcpacanada.ca/article-oncology-timelines
15. Glennie J et al. Curr. Oncol 2022;29: 981-988.