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

 

Comments are closed

Share an Article?

Writing an article is not only a great way to share your knowledge, but it is also a great way to give back to the community.

We value all our contributors and if you have a website, we will surely give a link back to your site and products.
Wanna contribute?

Suggestions?

Biosimilar News was started for the people who are interested in this rapidly growing business area. So if you have suggestions or feedback on how we can improve, please let us know. If you want to see a specific topic covered, answer to a specific question, or anything else of this sort, just write us. We do our best to keep up!
Make a suggestion now!