New medicine approval process to allow quicker access to breakthrough drugs

The Federal Government is changing the way new medicines are approved to ensure Australians get access to breakthrough drugs more quickly.

At the moment, Australian patients are being forced to wait up to two years longer to access some drugs than patients in the United States and Europe.

Under the changes being announced today, any drug that has been listed by a comparable overseas regulator, including the US Food and Drug Administration and the European Medicines Agency, can now be fast-tracked for approval and sale in Australia.

Health Minister Sussan Ley said the Therapeutic Goods Administration (TGA) would be able to share information with those overseas regulators, meaning it would no longer have to start the lengthy approvals process from scratch, in every case.

“What we need to do is accept the evidence that is being presented to those overseas regulators, bring that information to Australia, ensure our TGA is happy and ultimately list those medicines earlier,” she said.

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

Ms Ley said while regulators in the US and Europe were of the highest quality, the TGA would continue to have the final say over whether drugs were made available in Australia.

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

“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,” Ms Ley said.

“Often that means Australia has missed out but we don’t want to miss out, we want access to that drug.”

The Government allocated $20.4 million in the May budget to implement the changes, which will be rolled out over the next two years.

Referenced by  political reporter Jane Norman

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