George Masri provided an overview of proposed changes to Therapeutic Goods Administration (TGA) fees and charges in 2018-19, including those from the implementation of the Medical Devices Reform Bill 2. Key points included new fees for provisional approval pathways for medicines, changes to fees for listed and registered complementary medicines, fees for designating conformity assessment bodies, and potential increases to Good Manufacturing Practice licensing fees and annual charges for medical devices, complementary medicines, and provisional registrations. The session outlined proposed fee amounts and structures for various applications and assessments to better recover costs while streamlining regulations.

1. ARCS Reg Affairs Interest Session
March 2018
George Masri
Assistant Secretary
Regulatory Services & Improvement Branch

2. Overview
• MMDR Bill 2 – new fees and charges commencing in 2018
• 2018-19 possible changes in fees and charges
– Good Manufacturing Practice (GMP)
– Indexation
– Application fee for Class I medical devices
– Annual charges for complementary medicines
– Annual charges for provisional registration
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3. MMDR Bill 2 - Key Features
• Establish a scheme for provisional approval of promising new medicines
• Changes to regulation of complementary medicines, including:
• A new pathway under which listed medicines can be assessed for efficacy
• Establishing a list of permitted indications for listed medicines
• Providing incentives to develop new ingredients
• Streamlining and simplifying the framework for advertising therapeutic goods to the public
• Allowing greater use of assessments by comparable international regulators for medical
devices
• Providing refinements to allow Australian organisations, designated by the TGA, to conduct
conformity assessments of medical devices
• Enhanced compliance and enforcement powers and graduated penalties for non-compliance
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4. TG Bill 2 – Implementation timetable
• Bill 2 changes to the Therapeutic Goods Act:
– Passed by Senate and again House of Representatives on 15 February 2018
– Late passage of Bill 2 has caused delay to commencement of some reforms
which were planned to commence on 1 January 2018
– Bill 2 Regulations/reforms came into force on 20 March 2018
 Advertising complaints implementation 1 July 2018
 Removal of advertising pre-approvals will now begin from 1 July 2020
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5. TG Bill 2 - New fees commencing in 2017-18
– Application and evaluation fees for prescription medicine provisional pathway
– The designation fee for Provisional Approval $12,300
– *indicative fees presented in September 2017 TIF
Application fee ($) Evaluation fee ($) Total ($)
Designation extension fee 4,440 – 4,440
4,300*
Pre-market registration process – New prescription medicine 47,000 245,500 292,500
271,500*
Pre-market registration process – Extension of Indication 28,100 161,900 190,000
168,000*
Extension of Provisional registration 16,900 – 16,900
16,000*
Transition to full registration 28,000 118,100 146,100
-*
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6. Fees for listing pathways
• Pathway 1 – current listed complementary medicines pathway
– listing after choosing a permitted indication
– the current listing fee of $800 will continue to apply for pathway 1
• Pathway 2 – (new) listed assessed medicines pathway
– listing after efficacy assessment by TGA
Pathway 2 - New listed assessed medicines Application fee ($) Evaluation fee (S) Total fees ($)
L(A)1 - Evaluation of a clone of an existing product, where the only difference is the name and/or flavour,
fragrance, printing ink or colour
430 1,640 2,070
L(A)2 - Evaluation of efficacy based on international evaluation reports which meet the minimum data
requirements
1,760 13,400 15,160
L(A)3 - Full de novo evaluation of efficacy
An application for a new medicine not covered by NP1 or NP2, that is an extension to an existing approved
medicine, including: New therapeutic indications; New strength; New dosage form
1,760 13,400 15,160
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7. Fees for registered complementary medicines pathways
• Pathway 3 – registered complementary medicines pathway
– the current page count fee structure will be replaced
– new notification fee of $780 for some minor variations
• Assessment fees
Pathway 3 - Registered complementary medicines Application fee
($)
Evaluation fee
($)
Total fees ($)
RCM1 - Evaluation of a clone of an existing product, where the only difference is the name and/or flavour, fragrance,
printing ink or colour
530 3,060 3,590
RCM2 - Evaluation of safety, quality and efficacy based on international evaluation reports and/or accepted monograph
which meet the minimum data requirements
1,910 20,500 22,410
RCM3 - Evaluation of quality and either safety or efficacy based on international evaluation reports and/or accepted
monograph which meet the minimum data requirements AND de novo evaluation of either safety or efficacy
1,910 20,500 22,410
RCM4 - Evaluation of one of either safety, quality or efficacy based on international evaluation reports and de novo
evaluation of the two remaining parameters
- an application for a new medicine not covered by RCM1 – RCM3
2,530 27,800 2,530
RCM5 - Full de novo evaluation of safety, quality and efficacy
- an application for a new medicine not covered by RCM1 – RCM4
2,770 35,500 38,270
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8. Fees for registered complementary medicines pathways
(Variations)
• Pathway 3 – registered complementary medicines variation fees
Pathway 3 -Registered complementary medicines (Variations) Application fee
($)
Evaluation fee
($)
Total fees ($)
RCMC1 – Changes identified in the Changes Table as application level C1.
C1 applications do not need safety, efficacy and/or quality data or a justification for not providing the data.
1,380 - 1,380
RCMC2 – Changes identified in the Changes Table as application level C2.
• may require assessment of quality data
• do not need safety and/or efficacy data or a justification for not providing the data
730 3,960 4,690
RCMC3 – Changes identified in the Changes Table as application level C3.
• include changes to the quality, safety and/or efficacy of a medicine
• include changes to the medicine name where the new name requires a higher level of assessment, such as where there
is an identified risk associated with an umbrella branding segment
• require assessment of supporting safety and/or efficacy data or a justification for not providing the data
780 6,190 6,970
RCMC4 – Changes identified in the Changes Table as application level C4.
• include changes to the safety and/or efficacy aspects of the medicine
• require assessment of safety and/or efficacy data (clinical and/or toxicological) to support the proposed changes or a
justification for not providing the data
790 9,160 9,950
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9. Fees for new complementary medicine ingredients & permitted
indications
• New ingredients
• New permitted indications
– Application fee for new permitted indications $1,020
New ingredients Application fee
($)
Evaluation fee
($)
Total fees ($)
IN1 - Evaluation of safety and quality based on international evaluation reports which meet the minimum data
requirements
1,050 14,000 15,050
IN2 - Evaluation of safety based on international evaluation reports which meet the minimum data requirements
AND de novo evaluation of quality
1,050 14,000 15,050
IN3 - Evaluation of quality based on international evaluation reports which meet the minimum data requirements
or an accepted monograph AND de novo evaluation of safety
2,770 22,900 25,670
IN4 - Full de novo evaluation of safety and quality 2,770 22,900 25,670
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10. Fees for designation of conformity assessment bodies
• Fees for designation - Conformity Assessment Bodies (CABs) to undertake conformity assessment
certifications of medical devices
* Indicative fees presented in December 2017
Application fee ($) Assessment fee ($)
Full designation conformity assessment body determination 4,440
5,000*
71,700
80,000 – 100,000*
Partial designation conformity assessment body determination (full QMS) 2,410
3,000*
51,500
60,000-70,000*
Partial designation conformity assessment body determination (partial QMS or partial
devices)
2,410
3,000*
51,500
60,000-70,000*
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11. 2018-19 – Potential changes in fees and charges
• Potential changes required to TGA fees and charges in 2018-19
– Revised fees and charges model for GMP to address under-
recovery of GMP costs
– Indexation increase
– Application fee for class I medical devices
– Annual charges for complementary medicines
– Annual charges for provisional registration
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12. Good Manufacturing Practice
Proposed fees under Option 3 (recommended by Deloitte)
• Deloitte’s proposed changes
– Merge and reduce annual charges
 High level licence charge will reduce from $12,200 to $4,590
 Low level licence charge will reduce from $6,260 to $ 4,590
 No free audit hours from 1 July 2018
– Application fee of $770 for a licence variation
 This is a regulatory requirement
– New licence application fee will reduce from $1,000 to $770
– Domestic inspection fee $970 per hour (currently $660)
 Continue to apply to on-site hours only, not all inspection hours
 Includes travel and accommodation costs
– GMP clearance application fee to increase from $390 to $790
 This will also cover cost of MRA assessment without a need to introduce separate fee
• 3B Option
– GMP Clearance application fee increase to $640
– Compliance verification application assessment fee to increase by $400 to $2,430 11

13. Other proposed changes from 1 July 2018
• Indexation: CPI / WPI for the Sept to Sept quarters 1.8% and 2%,
50:50 composite index 1.9%
• $530 application fee for inclusion of Class 1 medical devices
• Annual charges for complementary medicines increase $80 per
ARTG entry
• Annual Charge for Provisional registration
– Provisional biological prescription medicine annual charge:
$16,200
– Provisional non-biological prescription medicine annual
charge:$13,100
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14. QUESTIONS?
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