No Investigational New Drug (IND) requirement, cash reimbursement
for research and development (R&D) expenditure and fast regulatory
approval make Australia the most attractive location for clinical
trials. As a city with a strong tradition of conducting clinical trials,
Adelaide offers a globally competitive environment.
REGULATORY ADVANTAGES
» No IND application required for First in Human (FIH) clinical trials.
» Human Research Ethics Committee (HREC) approval requires six weeks
and is valid in all participating jurisdictions.
» Ethics submissions consist of a protocol, investigator brochure and,
when required, an independent toxicology report.
» International Conference on Harmonisation (ICH) Good Clinical Practice
(GCP) compliancy with registration requirements of US Food and Drug
Administration (FDA), European Medicines Agency (EMA), Japan and
Canada regulatory bodies.
FINANCIAL INCENTIVES
» 45 per cent of R&D costs will be reimbursed in cash to companies with
an aggregated annual turnover of less than AUD$20 million
(approximately US$15 million).
» 40 per cent tax offset is offered to all other eligible entities.
» Incentives cover costs for clinical trials, analytics, study drug
manufacture and related services.
» Incentives cover all phases of development, i.e. preclinical, 1, 2, 3.
» Ability to claim the cost of R&D activities conducted overseas, when in
support of their Australian R&D project (under certain conditions).
Tel: +61 8 8463 6191
Visit: www.healthindustries.sa.gov.au
» A track record of successful claims by biotechnology and pharmaceutical
companies headquartered overseas (e.g. the US).
SIMPLE AND FAST SETUP PROCESS
» Before commencing R&D activities, investors interested in benefiting
from the financial incentives must set up a company incorporated in
Australia and with a local director (no need to hire full time employees).
» A formal agreement with the parent company is required.
» The whole process is inexpensive and can take as little as a month.
» All intellectual property (IP) remains with the parent company.
» Specialised professionals with a track record of successful claims are
available locally.
LOCAL INFRASTURUCTURE AND EXPERTISE
» Adelaide offers smooth transition from preclinical to clinical research
due to:
• its world-class large animal research facility
• frequent ethics committee assessment via Australia's first and largest
group of private HRECs (multiple monthly meetings)
• Australia's largest and most experienced phase 1 clinical trials unit
with a database of more than 13,000 active volunteers
• local providers of a complete range of clinical and bioanalytical
services for small and large molecule clinical trials
• local provider of applied clinical pharmacogenomics (PGx) services
• a range of established facilities for phase 2 and phase 3 trials.
» Adelaide has a clinical trial tradition across a range of disciplines,
particularly cardiology, dermatology, neurology, oncology, neonatal
science, and medical devices.
For more information on the inherent advantages of conducting your next
clinical trial in Adelaide, please contact Health Industries South Australia.
Tel: +61 8 8463 6191
Visit: www.healthindustries.sa.gov.au