Find out how to get your therapy to market sooner.
Get answers to your regulatory questions
Australia is the ideal place to fast-track approval for your drug or therapy for the FDA, EMA, CFDA or PMDA, while maintaining the highest ethical and quality standards. And here at Linear we have the clinical, medical and regulatory expertise you need to streamline the process. Check out our FAQs, or ask our team for advice.
What are the benefits for international clients conducting clinical trials in Australia? #
We have an extremely favourable regulatory system for clinical trials here in Australia. With no IND required and fast-track approvals, Australian (TGA) clinical trial start-up times are typically 4-6 months faster than US (FDA) trials, so you can fast-track your FDA and EMA submissions. Moreover, Australian trials are much cheaper – often a third of the cost – thanks in no small part to a generous R&D cash incentive from the Australian Government.
How does Australia’s generous R&D Tax Incentive scheme work? #
The Australian Government’s Tax Incentive scheme provides considerable financial enticement for clinical research and development activities in Australia. Here’s a quick breakdown of how it works:
Like many tax programs, the scheme can appear to be quite complex, but that’s why we’re here – together with our accountancy partners at CoSec, we’ll guide you through the process, cutting through the red tape and taking care of all the paperwork.
You can read about the R&D Tax Incentive scheme at www.business.gov.au. Alternatively, learn about CoSec’s expertise in this area, or contact our team for more information.
How does the clinical trial regulatory system work in Australia? #
Approval of a clinical trial in Australia is required to follow either the Clinical Trial Notification scheme (CTN) or the Clinical Trial Approval scheme (CTA).
The CTN scheme is followed in approximately 98% of all clinical trials that are approved and conducted in Australia, including Phase 1 and first-in-human clinical trials. With this route, the approving ethics committee takes responsibility for evaluating and ensuring:
the safety and efficacy of the medicine or device
the ethical acceptability of the trial process
the integrity of the trial protocol
the scientific merit of the trial.
Through the CTN scheme, Australia’s regulatory body – the Therapeutic Goods Association (TGA) – does not review any data relating to the clinical trial, but acknowledges the trial in writing within a number of days of receipt of the CTN form.
Under the CTA scheme, sponsors submit an application to conduct clinical trials (to the TGA), which the TGA evaluates and comments on. In the case of clinical trials for medicines, the TGA reviews information about the product provided by the sponsor, including:
the overseas status of the medicine
proposed usage guidelines
a pharmaceutical data sheet
a summary of pre-clinical data and clinical data.
The TGA delegate decides whether or not to object to the proposed usage guidelines for the product. If an objection is raised, trials may not proceed until the objection has been addressed to the delegate’s satisfaction. Even if no objection is raised, the delegate usually provides comments on the accuracy or interpretation of the summary information supplied by the sponsor. The sponsor must forward these comments to the HREC(s) at the sites where the sponsor intends to conduct trials under the CTA.
Sponsors cannot commence a CTA trial until written advice has been received from the TGA. Approval to conduct the trial must also be secured from HRECs at the institutions where the trial will be conducted.
What documents are required for ethics submissions? #
For ethics submissions, we require a protocol, investigator’s’ brochure and a Participant Information and Consent Form. Our team can write or assist with the development of your protocol and Participant Information and Consent Form.
The ethics committee also requires a certificate of currency (insurance certificate) and a Standard Medicines Australia Form of Indemnity.
Lastly, a Clinical Trial Agreement will need to be established between you (the sponsor) and us (Linear Clinical Research Ltd). Typically, we rely on the Standard Australian Clinical Trial Agreement as a template.
How long does it take you (Linear) to obtain ethics approval? #
As we’re established as an independent institution, we have the flexibility of submitting to the most appropriate ethics committee, depending on the therapeutic area and population of patients to be sourced.
For healthy volunteer and oncology studies (Phase 1) our preferred ethics committee is Bellberry Ethics Committee. Typical turnaround times are 4-6 weeks, often sooner.
How long does it take you (Linear) to commence a trial? #
Because we specialise in early-phase clinical trials, where data quality and speed are essential, we are set up to meet the most ambitious timelines, even for the most complex and challenging trials.
With dedicated project managers, research coordinators and study assistants, as well as dedicated recruitment, laboratory, medical, nursing and data transcription resources in-house, we can ensure that your trial will be ready for commencement once ethics approval is granted.