The TGA has released an important Public Consultation to remake the TGO 78 that will set the manufacturing standards for Tablets, Capsules and Pills for the next foreseeable decade. Traditional Chinese Pills are being incorporated into the new TGO with a 12 month transition.

Although many requirements remain unchanged, there are some significant changes including:

A) The ability to choose whether to apply the Australian specific requirements for compliance, or to use an applicable monograph for the specific finished tablet or capsule from the BP, EP, or USP (with additional specific requirements).

B) Regardless of which standard is chosen, the TGA are proposing that all listed and registered tablets, capsules and pills will have applicable impurity limits, specifically, Arsenic, Lead, Cadmium, Mercury, and residual solvents.

Submissions close on 8 February and the remade Order will be in place by 31 March 2019.

More information and details are included here.