Information sessions: Proposal to change GMP fees and charges
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.
Karstens - 111 Harrington Street
|14 February 2018||11:00am – 12:30pm||13 February 2018||Register for Sydney|
|2||2:00pm – 3:30pm|
Christie Corporate – 320 Adelaide Street
|16 February 2018||11:00am – 12:30pm||15 February 2018||Register for Brisbane|
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
If you have any questions, please contact the Manufacturing Quality Branch via GMP@tga.gov.au or call 1800 446 443.