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

8 February 2018

This consultation closes on 5th March 2018

Introduction

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.

Deloitte has now completed its review and put forward three options for TGA’s consideration after consultation with potentially impacted stakeholders.

Invitation to comment

The TGA is conducting a consultation to seek feedback from the potentially impacted stakeholders (ie: companies within the medicinal product pharmaceutical industry). It is important that every stakeholder consider the impact of changes to the current GMP fees and charges on their product/s and business/s.

Consultation document

How to access a pdf or Word document

About the consultation

The primary objective of this consultation is to seek stakeholders’ views on the options proposed by Deloitte for GMP fees and charges to address the under recovery of GMP activities for medicinal products. It is acknowledged that any changes would have varying impacts across sponsors and manufacturers.

Content of submissions

Responses should include:

  • Which option(s) you would support and why.
  • An assessment of how the proposed options will affect you and/or your businesses (either positively or negatively). Please attempt to quantify this (e.g. financial impacts).
  • Any other information you would like to provide to the TGA.

The TGA will also contact the Industry Associations who are members of the TGA –Industry Working Group on Good Manufacturing Practice (TIWGG). Industry Associations will collect and consolidate their members' feedback into a single submission to TGA where feasible.

How to submit

Complete the online Consultation submission form, upload your submission in either pdf or word format and click submit.

Consultation submission form

Alternatively, hardcopy submissions with a printed coversheet may be submitted via your TWIGG Industry Association representatives or electronically to TGA via email: GMP@tga.gov.au.

How to access a Word document

Timetable

Please include "Fees and charges consultation feedback" in the email subject. The closing date for submissions to the consultation is COB 5th March 2018

Privacy information

Submissions will be acknowledged as they are received. TGA will treat all responses and information provided IN CONFIDENCE.  TGA will collate and analyse submissions on matters that are within the scope of the consultation.

  • The TGA collects your personal information in this submission in order to:
    • contact you if the TGA wants to seek clarification of issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available.
    • help provide context about your submission (e.g. to determine whether you are an individual or a director of a company or representing an interest group).
    • Seek feedback about how the consultation was undertaken.
  • Please do not include personal information about other individuals in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.
  • More information on consultations and privacy is included in the submission form and on our website.

Planned Implementation

Following completion of the consultation process, a proposal will be submitted to seek the Ministerial approval to make changes to the GMP fees and charges. Subject to necessary approval of the regulatory changes, it is planned to implement the revised fees and charges from 1 July 2018.

The current practice of the TGA is to include a fixed number of inspection hours that will be undertaken but not billed over a three-year period. These have come to be known as ‘free’ hours.

From 1 July 2018 there will be no further accrual of ‘free’ inspection hours. As part of the transitional arrangement, domestic manufacturers who have unused ‘free’ inspection hours as at 1 July 2018 will be able to utilise them for further on-site inspections, until 30 June 2020.

Consultation - Information Sessions

As part of our stakeholder consultation, several information sessions will be held in Melbourne, Sydney and Brisbane. To register complete an the online registration via the information sessions page.

Contact us

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