Annual Charge Exemption (ACE) Scheme Compliance Program Updates

On Monday, 23 February 2026, the Therapeutic Goods Administration (TGA) published a Public Consultation on proposed amendments to the Therapeutic Goods Regulations 1990 (the TG Regulations).  

The proposed amendments relate to the conditions of participation in the TGA’s Annual Charge Exemption (ACE) Scheme. They aim to address issues identified through the ACE Scheme Compliance Program, including rising cases of sponsors not participating in compliance reviews and other instances of non-compliance which have previously gone undetected.

Should these changes be adopted, the Secretary or their delegate would be authorised to revoke annual charge exemptions on entries in the Australian Register of Therapeutic Goods (ARTG) and impose applicable charges under certain circumstances. These circumstances include:

• sponsor non-compliance with a Statutory Notice issued under paragraphs 31(1)(k), 31(2)(h), 32JA(1)(p), or 41JA(1)(j) of the Therapeutic Goods Act 1989 (the TG Act), or
• failure by the sponsor to demonstrate a $0 turnover for an exempted entry, as required under the scheme.

Further information on the Public Consultation – Annual Charge Exemption (ACE) Scheme Compliance Program Updates is available on the TGA Consultation Hub.

Feedback from sponsors will be essential to shaping effective policy and refining of the final regulations, kindly fill out your responses in the form below by COB March 13.