ARCS Reg Affairs Interest Session March 2018 George Masri - - PowerPoint PPT Presentation

ARCS Reg Affairs Interest Session

March 2018

George Masri Assistant Secretary Regulatory Services & Improvement Branch

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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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

2

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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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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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 5

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 6

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 7

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

• r 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 8

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*

9

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

10

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

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

12

QUESTIONS?

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