From Approval to Access: The Experts Weigh in
July 22, 2025
To better understand how Canada's accelerated drug approval pathways work in practice – and where improvements are still needed – we spoke with three experts who bring unique perspectives from different parts of the system.
Priority Pathways: A Regulatory Perspective
Dr. Jian Wang demystifies the Canadian accelerated drug approval landscape
Dr. Jian Wang, who holds both a medical degree and a PhD, joined Health Canada in 1996 as a toxicologist evaluator. Five years later he moved to the Biologic and Radiopharmaceutical Drugs Directorate, where he held various roles for over two decades until his recent retirement. Dr. Wang’s expertise has been crucial to the assessment of biological drugs to treat cancer and other diseases. The scope and impact scope of his work earned him the Queen Elizabeth II Diamond Jubilee Medal of Canada in 2012. He has contributed to numerous national and international working groups and committees, presented at conferences around the world, and been published widely. While Dr. Wang’s experience at Health Canada informs his candid discussion with 20Sense, he has retired from the organization and the views presented in this article are his own.
What are the pathways for accelerated review of drugs seeking approval in Canada?
The two pathways are Priority Review and advance consideration for notice of compliance with conditions [NOC/c], which means conditional authorization.
What can you tell us about Priority Review?
To qualify for a Priority Review, a drug has to meet criteria such as treating a serious disease and filling an unmet need or having an advantage over an existing therapy. The sponsor (drug manufacturer) has to submit what’s called a clinical assessment package, or CAP, with supporting data for assessment and qualification. After receiving a designated a Priority Review status, Health Canada commits to reviewing the file within 180 calendar days instead of the standard 300 days, by clinical and quality reviewers.
How about the other pathway, advance consideration for NOC/c?
Advance consideration has very similar criteria, with an important difference: the dataset is promising, but not complete. So the sponsor has to commit to conducting additional studies to obtain what we call confirmatory evidence. Health Canada invites sponsors to attend “presubmission meetings,” so they can receive guidance on preparing a suitable submission and addressing data gaps. For this pathway, the target review time is 200 days.
And just to clarify: even if a sponsor is submitting a drug along the regular or Priority Review pathway, it can still result in a NOC/c if Health Canada considers the data promising but insufficient.
Does Health Canada generally meet the accelerated timelines?
Yes. In my experience, Health Canada has never missed a deadline for at least a decade for cancer drugs. What people don’t always realize is that not everything gets counted in the target timeline. For instance, it can take 10 days to triage a file and figure out where it should go, and up to 25 to 40 days for screening a submission at the relevant directorate in Health Canada – that’s before the file gets reviewed. There’s also the time, up to 15 days, for the sponsor to respond to requests. The clock gets paused if sponsors need more time to respond. So it may appear that Health Canada is taking longer than the target timeline to review a file, but that’s not actually the case.
In general, do more drugs go through the Priority Review pathway or the NOC/c pathway?
It depends on the year and on the drugs that are seeking approval. The sponsor can use promising Phase 2 data to qualify for conditional authorization, so many different drugs may qualify.
Let’s move on to Project Orbis, the international collaboration to speed up access to cancer drugs. How does a drug make it to the coveted Orbis list?
It can go either of two ways: the sponsor can ask the FDA if their drug can be part of Project Orbis, or the FDA can propose it to the sponsor. If the sponsor makes the request, they have to tell the FDA which regulatory agencies they want to participate in the review. It can’t just be the FDA – regulators from partner countries have to be involved.
When a drug shows up on the Orbis list, what are the implications for Health Canada?
Sponsors who want to be part of Project Orbis are encouraged to communicate to Health Canada in advance, to see which regulatory pathway they would also qualify for. This also gives Health Canada a chance to prepare for the submission and to ensure they have the right resources to review and complete it in time.
Is it true that Health Canada has to review all Project Orbis drugs on an accelerated timeline?
Not necessarily. The FDA has different types of Project Orbis submissions. Type A submissions are expected to be reviewed very quickly and ideally result in early approval. It’s an aggressive timeline and Health Canada aims to follow it if possible. The sponsor also has to deliver the submission package very quickly – within 30 days after submitting to the FDA. There’s another category of submission called type C, which is not as aggressive. In such a case, the drug is usually not designated to be a priority or NOC/c by Health Canada.
Does Project Orbis make it easier for Health Canada to review a file?
Yes, it increases efficiencies and reduces redundancy. With Project Orbis drugs, Health Canada may participate in real-time discussions with all partner countries during the review and the FDA shares the full report with partner countries. Nevertheless, Health Canada still conducts an independent assessment and makes its own decision, but may leverage some of the FDA’s review data.
Let’s say Health Canada is involved in a Project Orbis submission and it results in approval. Will the approved indication in Canada always be the same as in the US or elsewhere?
Health Canada can review the file at the same time as the FDA and other regulators, with multinational discussions along the way. This often results in the same indication across jurisdictions – but not always. That’s because regulators may have different perspectives on risk/benefit of a drug and different regulatory approaches in their decision making and risk mitigation. Canadian regulators could end up with an indication that is not exactly the same as the FDA or other regulatory agencies.
Has bringing Project Orbis to Canada yielded any other benefits?
Yes. It encourages pharmaceutical companies to consider Canada earlier in their drug approval strategy. Normally, drug companies focus on the markets that are most important to them, because they have limited resources to deal with all regulators at the same time. This means they generally submit first to the big markets, such as the US and the EU, and only get to Health Canada later on. Thanks to Project Orbis, Health Canada receives some cancer drug submissions earlier than they otherwise would.
“Project Orbis encourages pharmaceutical companies to consider Canada earlier in their drug approval strategy, which means their submission may get to Health Canada earlier than it otherwise would.”
What do you think about Ontario’s recent announcement to include Project Orbis drugs in an accelerated access pilot?
I see it as a positive move, though I’m not sure how the province will select or prioritize the drugs to include in the pilot. It’s important to note that Health Canada doesn’t rank Priority Review or NOC/c drugs: either the drug meets the criteria, or it doesn’t. And from Health Canada’s perspective, being on the Project Orbis list doesn’t automatically change a drug’s priority status. Project Orbis is an international collaboration and review platform, not a regulatory triage system.
Anything else you’d like to add?
Although people focus on and sometimes complain about Health Canada’s drug approval process, we shouldn’t ignore what happens after approval – namely HTA and pricing negotiations. That’s where the access bottlenecks may occur.
New Drugs Need New Approaches: An Industry Perspective
Dr. Cathy Lau discusses accelerated approval pathways from the innovative pharmaceutical manufacturer side
With more than four decades in the pharmaceutical industry, Dr. Cathy Lau knows the drug approval process inside and out. She spent 10 years in clinical research, designing and running clinical trials in Canada and globally, and then served as VP of Regulatory Affairs at Janssen Canada for 16 years. As President of the Canadian Society of Pharmaceutical Sciences, she ran numerous workshops for Health Canada and other stakeholders on key topics in clinical trial and regulatory science. Dr. Lau is now an expert consultant on topics including the regulatory landscape and drug reimbursement. In this conversation, she shares her perspectives on how accelerated regulatory approval pathways are helpful for industry and patients – and where there’s still work to be done.
From the manufacturer side, how does a drug submission to regulatory bodies get started?
I would say 99% of companies start with a submission to the U.S. FDA, followed shortly by a submission to EMA (European Medicine Agency). At that time, they determine whether they are ready to submit to other countries because, for the Orbis process to work, they have to submit to all countries wanting to participate in the process around the same time. It’s common for companies to work simultaneously on the same dossier and apply any relevant changes for the local situation, so the country-specific applications for key markets might only be a couple of months behind the first one.
What impact has Project Orbis had on this process?
Most oncology reviews are now going through Project Orbis. If an application in Canada is lagging behind the FDA application and the Project Orbis review is already complete when Health Canada starts reviewing, they’ll look at the FDA review report to get a heads-up about FDA’s conclusions. They may not always follow FDA’s decisions regarding the final product label – Health Canada has a higher level of diligence for safety, so usually their decision won’t be identical.
Has Project Orbis improved the timelines for approval?
I don't know whether it has affected timelines. Health Canada really doesn't budge with their timelines – the fact that they have Project Orbis just makes it easier for them to complete their review. With rich information provided through the Orbis joint review, they can focus on issues that are most important to them.
“Health Canada really doesn’t budge with their timelines – Project Orbis just makes it easier for them to complete their review.”
From the manufacturer side, what changed in Canada when Project Orbis was instituted?
Overall, the impact has been positive. Oncology has so many novel drugs in the pipeline, and everyone is pushing for accelerated review, which means a lot of work to be completed in a very short time. I think before Project Orbis, Health Canada was sometimes more conservative, but these new drugs need a new approach and Orbis helps achieve that.
Project Orbis helped to highlight the key scientific areas and smooth out the back-and-forth between Health Canada and manufacturers. For example, regulatory agencies might not feel comfortable contacting a university professor and discussing confidential information about a drug, so information sharing among agencies can really speed up everyone’s understanding while maintaining confidentiality.
How do companies in the oncology space work with Health Canada’s accelerated pathways, Priority Review (PR) and Advance Consideration for Notice of Compliance with Conditions (NOC/c)?
Most companies in oncology won’t wait to get Phase III data, unless it’s a rare situation where they cannot conduct a Phase II study in the appropriate population. So Priority Review isn’t often an option. With the FDA approving most novel oncology drugs using accelerated pathways, in Canada about 90% of applications are going through the NOC/c pathways using Phase I and II data. There’s almost no choice but to use the NOC/c pathways, because the whole world is going this way – the FDA only needs Phase I and II data for approval, which influences the global regulatory landscape.
What is your perspective on the recent Ontario announcement about an accelerated listing pathway for drugs that receive approval via Project Orbis ?
I think they're right and this is a good way forward. If a high impact drug goes through Orbis and is confirmed to be active by other regulatory agencies, it seems reasonable to predict that it will receive a positive approval and health technology reimbursement recommendation in Canada. Figuring out how to manage listing and pricing may be a challenge for the province, but I think if ways can be found to incorporate, for example, additional data from comparable patient populations or trial designs, or real-world evidence, that should help with funding decisions so that patients can access and benefit from the drug.
Harnessing the Potential of Accelerated Pathways: A Policy Perspective
Dr. Judith Glennie is calling on Canadian policymakers to re-think their processes – and their priorities
When it comes to drug policy and access in Canada, Dr. Judith Glennie has seen it from pretty much every angle. A clinical pharmacist by background, she’s worked in academia, government, tertiary care hospitals, and industry. She’s also helped shape healthcare policies and processes at both the provincial and federal levels. For the past 13 years she’s been a valued consultant on pharmaceutical policy, advising non-profit groups, governments, and pharmaceutical companies on issues relating to patient access, with a focus on oncology, rare diseases, and cell and gene therapies. Here’s Judith’s take on what needs to change at the policy level in Canada for the full potential of Project Orbis – and other accelerated approval pathways and initiatives – to be realized.
Has Canada’s involvement in Project Orbis improved timelines for access to oncology treatments?
I don’t think we can say that Project Orbis alone has improved timelines for oncology treatments because so many other parts of the system haven’t aligned with it yet. For the last decade or so, Health Canada has not been a big part of the problem in our current drug access system – their timelines and processes are relatively predictable. It's everything else. There were no changes made to Canada’s Drug Agency’s (CDA-AMC) processes or at the pan-Canadian Pharmaceutical Alliance (pCPA) or provincial level to accommodate products approved under Project Orbis. If these bodies don't all agree that they are going to accelerate their processes for a Project Orbis product, then Health Canada’s actions don’t significantly impact the overall timeline.
“Over the past decade or so, Health Canada has not been a big part of the problem in our current patient access system – it's everything else.”
What needs to be done to improve that alignment in Canada?
We’re starting to see some good political momentum toward speeding up drug access – the recently announced pilot program in Ontario to fast-track high-priority cancer drugs12 looks like a big step in the right direction, and reduced wait times were also part of [now Prime Minister] Mark Carney’s platform for the federal election. All parts of the system need to commit to working together, and that includes political leaders directing their drug program staff - and also critically CDA-AMC and pCPA - so that everyone can align on prioritization objectives. Project Orbis products could be used as a starting point, but the commitment and collaboration should go beyond those medications – many non-oncology products are just as important.
The key leaders from these groups need to sit down and figure out how to fix the delays in drug access, on a very specific and short timeline: months, not years. It’s great that Ontario is getting things started. In the past they’ve led the way on things like the pan-Canadian Oncology Drug Review (pCODR), pCPA, and the rare disease drug strategy, with other provinces and/or CDA-AMC eventually bringing those programs and/or policies on board.
“The key leaders from these groups need to sit down and figure out how to fix the delays in drug access, on a very specific and short timeline: months, not years.”
What broader impact do you think Project Orbis and the initiatives to align processes and timelines might have for medication access in Canada?
We have an opportunity to improve patient equity in access to therapies. Part of the purpose of nationalizing policies and processes under CDA-AMC and the pCPA was to eliminate discrepancies in access across Canada. We’ve slowly addressed some of those inequities, but things aren’t perfect yet. We could really improve equity if all provinces would pledge to a front-end to back-end commitment to Project Orbis products. But, again, it has to go beyond oncology because there are many discrepancies in treatment access in other therapeutic areas.
The other issue that we need to address – particularly at the provincial level – is the issue of timely health system implementation planning. True patient access means getting drugs into patients – so if our health systems are not able to integrate these priority products due to lack of health system readiness, then we have still failed to achieve our goal.
I find that once every 20 years or so, there is an opportunity to fundamentally improve the Canadian medication access system. Now we have this aligned messaging from Premier Ford, from the Council of the Federation, from the federal government, all moving in the same direction and talking about accelerated access and improving patient outcomes. What a great opportunity for the provinces and the feds to work collaboratively with Health Canada and examine processes at every level and find ways to work more in parallel. Even if the provinces can’t all agree on everything, we can still get things moving.
“Once every 20 years or so, there is an opportunity to fundamentally improve the Canadian medication access system.”