TGA boss warns about streamlining approvals

The Australian

3 October 2016 - The head of the Therapeutic Goods Administration, John Skerritt, has warned that federal government reforms to streamline approvals of medicines and medical devices will be “harder than we think” to implement, as he argues other countries are yet to agree to share information to aid faster domestic approvals.

Professor Skerritt, a deputy secretary at the federal Health Department, said implementation of the reforms, announced last month by Health Minister Sussan Ley, would be “complex”.

“It won’t be impossible, but we need to think it through,” he told device manufacturers at a recent industry event in Sydney.

He said moving from a couple of different pathways to bring products to Australia to many different pathways, which the reforms proposed, created complexities that had to be managed.

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Michael Wonder

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Michael Wonder