The trade name, active ingredient, type of cell or tissue, and sponsor for each new biological reflects the information initially included in the ARTG.
Once an application has been accepted for evaluation by TGA, the approval time is defined as the number of TGA working days between commencement of evaluation and registration decision. TGA works to business target timeframes as well as to legislated timeframes for each category of application. Approval times are underpinned by legislation (see Therapeutic Goods Regulations 1990) and excludes public holidays, weekends, time allocated to the sponsor to respond to requests for information, and 'mutual clock stop' periods agreed with the sponsor.
From 2018, approval times are reported in the number of TGA working days for each decision, along with the legislated timeframe (unless otherwise indicated) for that category of application in brackets.
Class 1 biologicals only require a statement of compliance to be included in the ARTG and so are only reported with a date of registration.
Inclusions of new biologicals
To view all biologicals included on the ARTG by year, please search our Prescription medicines registrations database.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.