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TGA fast track twice the price
Posted 9 April 2018
The TGA's new provisional pathway could cost sponsors almost double that of the standard pathway for new chemical entities, according to information published by the TGA.
The minimum total cost incurred for a provisional medicine application clocks up to $450,900, making the pathway almost twice the price of the standard $234,200 application tag.
However, as fees for renewal of a medicine's provisional status could add $16,900 every two years for a maximum of two renewals, the cost of a provisionally approved medicines could rise even further and exceed the cost of standard pathway medicines twice over.
The fee to register a provisional medicine in Australia now includes a $12,300 determination fee (used in the pre-application process to determine the therapy's eligibility for the provisional program), a $292,500 provisional review fee and a further $146,100 fee once the medicine is ready to transition to standard approval.
The main provisional review fee is $57,400 higher than standard pathway review and was set to "reflect additional activities," according to the TGA, including additional checking activities, collaboration, expert advice and time required for the dossiers.
Given the TGA has said the provisional pathway could bring new therapies "to the market up to two years sooner than in the current framework", the additional fee will mean sponsors pay an estimated $108,350 per extra early year on the ARTG.
The TGA statement also outlined the difference in fees between standard review and the priority review pathway, implemented last July. Priority review costs $13,700 more per application due to "the additional effort required to complete the ... process within a reduced target timeframe of 150 working days".
TOTAL REVIEW COSTS FOR TGA PATHWAYS
Fees
Standard
Priority
Provisional
Designation/determination fee
-
$12,300
$12,300
Application Fee
$46,000
$49,800
$47,000
Evaluation Fee
$188,200
$199,000
$245,500
Transition to full registration (application)
-
-
$28,000
Transition to full registration (evaluation)
-
-
$118,100
Extension of designation/determination
-
-
$4,440 (max once)
Extension of provisional registration
-
-
$16,900 (max twice)
Total minimum cost*
$234,200
$261,100
$450,900
*does not include extension fees
Provisional medicines would also incur a higher annual charge according to a presentation the TGA gave at an ARCS interest session.
The presentation said "other proposed changes" to fees set to begin this July would include a $16,200 annual charge for provisional biological medicines, and a $13,100 charge for provisional non-biologic medicines.
The currently standard is an annual charge of $6990 for biological medicines and either $3230 or $3980 for non-biological medicines, meaning provisional annual charges would be more than double those for standard therapies.
Last September MA warned the higher TGA fees for a provisional pathway could mean some sponsors would be unwilling to the use the new framework to register medicines.
Yajun Ma
Posted 9 April 2018
The TGA's new provisional pathway could cost sponsors almost double that of the standard pathway for new chemical entities, according to information published by the TGA.
The minimum total cost incurred for a provisional medicine application clocks up to $450,900, making the pathway almost twice the price of the standard $234,200 application tag.
However, as fees for renewal of a medicine's provisional status could add $16,900 every two years for a maximum of two renewals, the cost of a provisionally approved medicines could rise even further and exceed the cost of standard pathway medicines twice over.
The fee to register a provisional medicine in Australia now includes a $12,300 determination fee (used in the pre-application process to determine the therapy's eligibility for the provisional program), a $292,500 provisional review fee and a further $146,100 fee once the medicine is ready to transition to standard approval.
The main provisional review fee is $57,400 higher than standard pathway review and was set to "reflect additional activities," according to the TGA, including additional checking activities, collaboration, expert advice and time required for the dossiers.
Given the TGA has said the provisional pathway could bring new therapies "to the market up to two years sooner than in the current framework", the additional fee will mean sponsors pay an estimated $108,350 per extra early year on the ARTG.
The TGA statement also outlined the difference in fees between standard review and the priority review pathway, implemented last July. Priority review costs $13,700 more per application due to "the additional effort required to complete the ... process within a reduced target timeframe of 150 working days".
| TOTAL REVIEW COSTS FOR TGA PATHWAYS | |||
| Fees | Standard | Priority | Provisional |
| Designation/determination fee | - | $12,300 | $12,300 |
| Application Fee | $46,000 | $49,800 | $47,000 |
| Evaluation Fee | $188,200 | $199,000 | $245,500 |
| Transition to full registration (application) | - | - | $28,000 |
| Transition to full registration (evaluation) | - | - | $118,100 |
| Extension of designation/determination | - | - | $4,440 (max once) |
| Extension of provisional registration | - | - | $16,900 (max twice) |
| Total minimum cost* | $234,200 | $261,100 | $450,900 |
*does not include extension fees
Provisional medicines would also incur a higher annual charge according to a presentation the TGA gave at an ARCS interest session.
The presentation said "other proposed changes" to fees set to begin this July would include a $16,200 annual charge for provisional biological medicines, and a $13,100 charge for provisional non-biologic medicines.
The currently standard is an annual charge of $6990 for biological medicines and either $3230 or $3980 for non-biological medicines, meaning provisional annual charges would be more than double those for standard therapies.
Last September MA warned the higher TGA fees for a provisional pathway could mean some sponsors would be unwilling to the use the new framework to register medicines.
Yajun Ma
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