Aussies to gain faster access to breakthrough medicine under new regulations

0 Comment(s)Print E-mail Xinhua, September 15, 2016
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The Australian government has on Thursday announced it will speed up the approval process for new medicines so that Australians can gain faster access to breakthrough drugs.

Currently, many Australians are forced to wait up to two years longer than counterparts in other nations, but the new rules will allow drugs to be "fast-tracked" if they're approved by a similar overseas regulator such as the United States' Food and Drug Administration (FDA), Health Minister Sussan Ley said on Thursday.

"What we need to do is accept the evidence that is being presented to those overseas regulators, bring that information to Australia, ensure our Therapeutic Goods Administration (TGA) is happy and ultimately list those medicines earlier," she said.

"Ultimately this is all about consumers getting access to medicines earlier."

Ley said while comparable overseas agencies test and monitor drugs at a high level, it will still by up to the TGA to have the "final say" on whether or not a medicine will be approved for use in Australia.

She said the changes would also allow pharmaceutical companies to list their drugs in Australia at the same time as they list them in larger, more lucrative overseas markets.

"Ultimately we know pharmaceutical companies tend to list where the market is larger, the patient number is larger and they're going to sell more of the drug," Ley said.

"Often that means Australia has missed out but we don't want to miss out, we want access to that drug."

The changes will reportedly be implemented over the next two years. Endit

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