Approving new cancer drugs - TGA Review

[Paul Edwards]

An Independent Review has been examining the regulatory framework for medicines and medical devices administered by the Therapeutic Goods Administration with a view to identifying areas of unnecessary, duplicative, or ineffective regulation that could be removed or streamlined and opportunities to enhance the regulatory framework.

 

 

The Review which has been conducted by a panel of 3 independent experts, Emeritus Professor Lloyd Sansom AO, Mr Will Delaat AM and Professor John Horvath AO, has just released its first report.

 

 

The TGA Review makes a total of 32 recommendations which are now being considered by the Government.

 

 

The review found that Australia was being unfairly categorised as ‘slow’ when compared to the rest of the world because some drug companies were making Australians wait for medicines while they first tested them in bigger markets like the US and Europe.  The review found that Australia was waiting on average about six months longer than the US and Europe for drug companies to apply to list new medicines here.

 

 

We welcome the Report’s recommendations for new ways to expedite drug approvals through a multi-tiered approval system.  It recommends the fast tracking of drugs already approved in the US and Europe.

 

 

A multi-tiered approval system with fast tracking was something which the Advanced Prostate Cancer Support Group suggested in our submission to the Senate Inquiry into The availability of new, innovative and specialist cancer drugs in Australia.   The report of the Senate Inquiry, which was due to be released in March, is now due to be released in early August.

 

 

The full report of the TGA Review and its recommendations are available by clicking on this link

 

 

The Government’s press release can be read by clicking on this link.