Standards, guidelines & publications (biologicals)

Australian regulatory guidelines for biologicals (ARGB)
These guidelines provide information for manufacturers, sponsors, health professionals and the general public on the legal arrangements in Australia for the supply and use of human cell and tissue-based therapeutic goods (collectively defined as 'biologicals')
Biological standards
All products within the scope of the regulatory framework for biologicals must comply with the requirements in the legislation.
Excluded Goods Order No. 1 of 2011: Guideline for Items 4(o), 4(p), 4(q) and 4(r)
Outlines the circumstances in which certain products of human origin would not be treated by the TGA as coming within the regulatory framework
New biologicals based on a parent biological
Guidance is for sponsors of biologicals who want to make a change to that biological (parent biological) where the change creates a separate and distinct good (new biological)

Category:

Biologicals

Tags:

regulatory guidance

URL:

Therapeutic Goods Administration (TGA)