TGA seeks industry input on adopting 11 international scientific guidelines in Australia

The Therapeutic Goods Administration announced it will consider incorporating eleven internationally recognised scientific guidelines into the Australian regulatory framework.

The agency has opened a consultation period, inviting stakeholders to comment on how the new standards could be applied to medicines, medical devices and other therapeutic goods.

In related regulatory news, the U.S. FDA has proposed an amendment to 21 CFR Part 207 that would let distributed manufacturers register as a single establishment, a change that could shift focus toward maintaining product consistency across multiple sites.