Each year, TGA approves new biologicals for inclusion in the Australian Register of Therapeutic Goods (ARTG).

The decision to approve a new biological comes after a comprehensive review by TGA scientists and clinicians of the product’s quality, safety and efficacy of the proposed use of the biological. TGA classifies biologicals according to the level of risk to patients associated with their use and may be either Class 1 (lowest risk), Class 2, Class 3, or Class 4 (highest risk) biologicals.

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, 2021