Senate Community Affairs Legislation Committee, , 1:29:51 to 1:37:26
The Therapeutic Goods Administration (TGA) outlines trends in the approval of new active substances and novel therapies. Discussion covers international work-sharing through the Access Consortium and how Australia's market size and geography influence global filing timelines for new medicines.
Topics: Health, International law
Speakers: Prof Anthony Lawler, Speaker 24, Chris Gatenby, Unknown Speaker
Thanks, Chair. Um the question to the TJ Um to sort of dovetail off the back of my question yesterday about. Strategic agreements, which I know we don't, you know, there's not too much information on that at the moment, given you in negotiations. But how many novel new therapies are typically registered with a TGA in any given year?
Just uh wait from colleague Mr. Henderson to arrive. Nick Henderson, First Assistant Secretary of Medicine's regulation vision. Thanks for the question, Senator. Approximately it's about 50 per year, but I can find the exact numbers for last uh financial year for you, Senator.
I just for the last how many were registered last year would be useful. Is that something you're looking for now or can I come back or I can find
so there's various categories of applications that we receive. So category A is the novel um applications. So for 2026, um we we currently uh have on hand 37. Um and as I said, Senator, we we tend to approve it between 40 and 50 each year.
So is this by financial year or is this calendar year?
Oh, that's uh calendar year.
And do you have sort of how many how much data have you got? Have you got sort of the last five years?
Um I'll have to take that on notice.
Okay, that would be great.
Um sorry, if I might add Senator, one of the things that we do have a have a mind to is obviously placing those um those in in context. Uh we we work very closely with uh with other regulators. Um one of the areas, one of the organizations that we do some work with is called the um Centre for Innovation Regulatory Science, which does a lot of analysis and what it's actually showing um in that analysis is that the number or the trend I should say in uh in the approval of of new active substances um has gone up. Where we're performing quite well when compared even to um larger organizations like like the FDA or the European Medicines Agency. But I think it's also important to take that the num when we do provide those numbers to take them in the context uh that that will cover as well the period uh of COVID, which obviously will have had an impact as well.
Okay. And so the number of new novel therapies registered, if that's what we're nearly in November of 37 this year. Is there a reason why there's a been a decline in the numbers this year? Have you got any reasons that might be the case?
So that 37, Senator, is the the current novel applications that we're um evaluating. Um there are other categories, so um we also um receive uh applications to extend the indications of of current prescription medicines and we have 51 of those on hand as well.
So 51 extensions and 37 new to date. But if we've got 50, or what's that 13 different say to last year? Um is there any particular reason why we might be seeing fewer new novel therapies coming through for registration?
Um I don't not that I'm aware of, Senator, but um in addition to receiving the applications, we do have what we call pipeline meetings with sponsors of of medicines and um pleasingly what we are hearing through those pipeline meetings is that there is a a strong pipeline of um novel uh medicines coming through and um another pleasing aspect of those discussions is that um a lot of the sponsors are seeing Australia as as uh as a place where they would like to um seek registration and seek that registration um you know firstly. We we do tend to experience a bit of a what we call a lag in relation to registrations compared to like the US FDA, um but pleasingly we are seeing that um sponsors are looking to Australia as part of their global filing uh as a place for um initial registration of their medicines.
So, Mr Henderson, you don't think there's any hesitancy because of HTA reforms or you're not seeing or hearing that from any of the companies at all, particularly about the new new therapies. Obviously, extensions are you know roll over for you know different purposes, but um are you are you seeing that or hearing that?
So I if I might I mean uh I'll I'll I'll throw into Sanderson in a moment as well. But the I I guess there are a couple of things to note. Um there's no I think there's no secret um that that uh um the Australia faces different challenges to to some other markets, the size of the market uh when we compare to um where uh many of these medicines are first registered, such as uh which is predominantly the FDA, it's predominantly US, uh, and then the second market is usually the European Medicines Agency. That that for the most part is a function of population size and market size. Uh so we recognise that that presents a challenge for for Australia as well. Um we also see uh, and it's it's it's no secret, it's manifest in some of the challenges we have around supply chain is simply geographically that Australia is is a challenge. Well what we do here though in our regular interactions with industry, we we conduct regular bilaterals not only kind of annually but also we have regular touch points with industry, is that um our regulatory setting seem to be right and there's work that's being undertaken obviously in respect to HTA. I think the the the two other things I would just highlight, Senator, is it's important to note that our trend over the last five to ten years in terms of um new active substance approvals has been upwards, and it's just um I would just uh uh urge caution in comparing last year's performance against Issy's performance in in just year on year there can there can be movements. But also we're very active in in working through ways of addressing some of those disincentives that I've identified. Um and one of those is that we have some very strong reliance mechanisms with other regulators so that we endeavour to shorten their submission gap, but we also engage in what we call work sharing arrangements with uh other regulators and probably the the one that I would highlight is what's called the access consortium where where ourselves uh Health Canada uh Swiss Medic Health Health Science Authority uh in Singapore and the medical and the medicines and health care products regulatory agency in in the UK together share um assessment of applications which provides uh an expedited approach to accessing uh 150 million uh patients as a market. So we're mindful that there are some uh potential disincentives, uh, but we're um we're uh taking action through regulatory options to address that.
And how many novel therapies are PBS listed compared to TJ or ARTG listed?
I'll have to take that on on notice. Okay, sorry, Senator.
That's right, that's all.
That may be a question for our for our for our PBS colleagues, I suspect under that community.
That's fine. Thank you. Appreciate it.