Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Big Risks From Quick Drug Trials (Australia)

This article was originally published in PharmAsia News

Executive Summary

Australian clinical drug trials must be approved by an ethics committee, which was formed in 1991 in an attempt to speed up the drug research and development process. Before that, all trials had to be approved by the Therapeutic Goods Administration. The committee has dramatically cut approval time from three years to three months. The quick approval process allowed over 3,000 clinical sites to be registered for trials last year. The Australian drug industry invests about $520 million a year on research and development. Approximately 90 percent of that money goes to clinical trials. In addition, many large U.S.-based pharmaceutical companies have also been attracted to the Australian R&D market. But critics worry the system may be too lax. Although there have been no major problems in Australia, health and safety regulations have been under increased scrutiny around the globe. Last year six healthy volunteers in England died during a drug trial, highlighting the risks of a clinical trial system that is largely self-regulating. (Click here for more

You may also be interested in...

Accelerating The Global Self-Care Agenda: Q&A With GSCF Chair, Bayer CH Head Heiko Schipper

HBW Insight speaks to new Global Self-Care Federation chair and Bayer CH chief Heiko Schipper about the role that self-care can play in alleviating pressure on national health care systems, the importance of self-care's scientific credentials and of maintaining supply chain continuity during the coronavirus pandemic.

A Stroke Of Luck Boosts Oxford/AZ’s “Vaccine For The World”

AstraZeneca's research head admits that half dose approach was a lucky mistake - but one that could boost the vaccine's effectiveness and supplies. The US regulator may not be persuaded, however.

Innovation-Friendly? Cases Indicate How Far China's Willing To Protect Patents

Increasingly looking to China to commercialize their latest therapies, multinationals may be leaping into unknown waters to navigate an intellectual property judiciary and administrative maze, in a country where some copy drugs have been approved before patent expiry. With a government trying to balance innovation and access, two recent rulings involving AstraZeneca shed rare light onto China’s protections for innovation, with advisors pointing to challenges and success factors.




Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts