Submissions received: Proposal to change the medicine GMP fees and charges

21 May 2018

The TGA would like to thank respondents who provided submissions in response to the February 2018 public consultation paper, Consultation: Proposal to change the current Good Manufacturing Practice (GMP) fees and charges.

Consultation closed on 5 March 2018 and a total of 31 submissions were received, which comprised:

  • 14 submissions from Australian sponsors
  • 8 submissions from industry associations and peak industry bodies
  • 4 submissions from Australian manufacturers
  • 1 submission from a regulatory affairs consultant
  • 1 submission from a research organisation

All submissions that gave permission to be published on the TGA website are now available below in PDF format.

Submissions

A B C G M N P S T

A

B

C

G

M

N

P

S

T

  • Teva Pharma Australia Pty Ltd

TGA response

Submissions received in response to the consultation showed that the majority of stakeholders support the TGA's need to fully cost recover activities and a model which encourages increased compliance. 3 submissions were excluded from our analysis as these did not relate to GMP fees & charges.

Generally sponsors preferred option 2 and manufacturers preferred option 3. Several suggestions were also submitted to TGA to slightly modify option 3 to address under recovery for the compliance verification (CV) assessment application separately from the GMP clearance application processing fee. As a result of this feedback we developed an additional option (referred to as option 3B).

Option 3B is outlined below and has been endorsed for implementation;

  • fees related to Domestic Manufacturers will become effective from 1 July 2018; and
  • fees related to GMP Clearances will become effective from 1 July 2019.

Further information on implementation arrangements will be included on the TGA website in the coming weeks.

Outcome summary

Summary of GMP fees & charges for medicines (Option 3B)

Fees and Charges for Australian Manufacturers – effective from 01 July 2018
Fees and Charges Current Fee Revised Fee
Annual Manufacturing Charges
(From 1 Jul 2018 this fee will replace the Low & High Level Annual Licence Manufacturing Charge)
- $4,590
Low-Level Annual Licence Manufacturing Charges $6,260 Replaced by Annual Manufacturing Charge
High-Level Annual Licence Manufacturing Charges $12,200
Australian Manufacturing Hourly Inspection Fee $660 / per hour / per inspector $970 / per hour / per inspector
GMP Licence Application Fee $1,000 $770
GMP Licence Variation Fee - $770
Certificate of GMP Compliance $170 $180 *
Certified Copy $60 $70 *
Fees and Charges for GMP Clearance applications – effective from 01 July 2018
Fees and Charges Current Fee Revised Fee
GMP Clearance Application Processing Fee
(per manufacturer, per site, per sponsor)
$390 $400 *
Obtaining Evidence from Overseas Regularity Authority fee
(per manufacturer, per site, per sponsor)
$680 $690 *
Compliance Verification fee
(per manufacturer, per site, per sponsor)
$2,030 $2,070 *
Fees and Charges for Overseas Manufacturers – effective from 01 July 2018
Fees and Charges Current Fee Revised Fee
Overseas Manufacturing Hourly Inspection Fee $1,330 / per hour / per inspector $1,360 * / per hour / per inspector
Overseas Inspection Travel costs Recovered at cost Recovered at cost

Fees and charges for 1 July 2018 implementation are subject to passage of Therapeutic Goods Legislation (Fees and Other Measures) Regulation 2018 and Therapeutic Goods (Charges) Regulation 2018.

* A general increase of 1.9% will be applied to fees and charges from 1 July 2018. As part of the Therapeutic Goods Administration's (TGA) annual review of its fees and charges, for the last number of years, a formula for assessing the impact of indexation on its cost recovery has been used. This formula is comprised of the Australian Bureau of Statistics (ABS) Consumer Price Index (CPI) and Wage Price Index (WPI) for the year to September. In applying the 1.9% increase, fees and charges up to $10,000 would be rounded to the nearest $10 (with a minimum increase of $10 for items below $260) and fees above $10,000 would be rounded to the nearest $100.

Fees and charges for GMP clearance applications adopted under option 3B have a delayed implementation date of 1 Jul 2019. These fees are outlined below:

Fees and Charges Fee from 1 Jul 2018 Proposed fees effective from 1 Jul 2019
GMP Clearance Application Processing Fee $400 $640 **
Compliance Verification fee $2,070 $2,430 **

** These fees may be subject to additional increase in accordance with the annual general increase, in accordance with the Therapeutic Goods Administration's (TGA) annual review of its fees and charges.