Australian Biosimilars Guideline

August 23, 2011 6:28 AM

The Australian regulatory body that is responsible for assessing and approving new medicines and medical devices (therapeutic goods) is the Therapeutic Goods Administration (TGA).

TGA is a division of the Australian Government Department of Health and Ageing and is responsible for medicines, medical devices, blood and blood products.

TGA administers the Therapeutic Goods Act 1989. This legislation provides a framework for a risk management approach that allows the Australian community to have timely access to therapeutic goods which are consistently safe, effective and of high quality.

Australia adopted guidelines from the European Union on similar biological medicinal products in August 2008.

These guidelines cover all biosimilar products:

Guideline on similar biological medicinal products

Additionally TGA has also adopted the product-specific EMA guidelines and published them on their website.

Source:  TGA


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