Information sessions: Proposal to change GMP fees and charges

9 February 2018

The Therapeutic Goods Administration (TGA) engaged Deloitte to undertake a review of its current Good Manufacturing Practice (GMP) fees and charges for medicines and Active Pharmaceutical Ingredients (APIs). The purpose of the review is to improve the accuracy and transparency of the cost recovery arrangements for that regulatory function and address a significant under recovery over the past four financial years.

The review does not include fees and charges related to medical devices, human blood, blood component, and haematopoietic progenitor cells (HPC) or biological products.

As part of our stakeholder consultation, several information sessions will be held in Melbourne, Sydney and Brisbane. The primary objective of these sessions is to present a number of options and to seek stakeholders’ views on the proposed options for GMP fees and charges.

Who should attend the information sessions?

Companies within the medicinal product pharmaceutical industry, such as;

  • Australian licensed manufacturers of medicines or Active Pharmaceutical Ingredients (APIs)
  • Australian sponsors of medicines or APIs which are manufactured overseas

How to register

Please complete a separate online registration for each attendee. Places for these sessions are limited so we encourage you to register quickly.

List of upcoming GMP sessions
  Location Date Time Registration closes Register
1 Sydney
Karstens - 111 Harrington Street
14 February 2018 11:00am – 12:30pm 13 February 2018 Register for Sydney
2 2:00pm – 3:30pm
3 Brisbane
Christie Corporate – 320 Adelaide Street
16 February 2018 11:00am – 12:30pm 15 February 2018 Register for Brisbane
4 Melbourne
Commonwealth Health Offices – 595 Collins Street
19 February 2018 11:00am – 12:30pm 16 February 2018 Register for Melbourne
5 3:30pm – 5:00pm

Consultation document and invitation to comment

Consultation: Proposal to change the current good manufacturing practice (GMP) fees and charges

Contact us

If you have any questions, please contact the Manufacturing Quality Branch via or call 1800 446 443.