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 1
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 3
TG Bill 2 - New fees commencing in 2017-18 – Application and evaluation fees for prescription medicine provisional pathway – The designation fee for Provisional Approval $12,300 Application fee ($) 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 -* – *indicative fees presented in September 2017 TIF 4
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 ($) 430 1,640 2,070 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 1,760 13,400 15,160 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 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, 530 3,060 3,590 printing ink or colour RCM2 - Evaluation of safety, quality and efficacy based on international evaluation reports and/or accepted monograph 1,910 20,500 22,410 which meet the minimum data requirements RCM3 - Evaluation of quality and either safety or efficacy based on international evaluation reports and/or accepted 1,910 20,500 22,410 monograph which meet the minimum data requirements AND de novo evaluation of either safety or efficacy RCM4 - Evaluation of one of either safety, quality or efficacy based on international evaluation reports and de novo 2,530 27,800 2,530 evaluation of the two remaining parameters - an application for a new medicine not covered by RCM1 – RCM3 RCM5 - Full de novo evaluation of safety, quality and efficacy 2,770 35,500 38,270 - an application for a new medicine not covered by RCM1 – RCM4 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 ($) ($) ($) 1,380 - 1,380 RCMC1 – Changes identified in the Changes Table as application level C1. C1 applications do not need safety, efficacy and/or quality data or a justification for not providing the data. 730 3,960 4,690 RCMC2 – Changes identified in the Changes Table as application level C2. • may require assessment of quality data • do not need safety and/or efficacy data or a justification for not providing the data 780 6,190 6,970 RCMC3 – Changes identified in the Changes Table as application level C3. • include changes to the quality, safety and/or efficacy of a medicine • include changes to the medicine name where the new name requires a higher level of assessment, such as where there is an identified risk associated with an umbrella branding segment • require assessment of supporting safety and/or efficacy data or a justification for not providing the data 790 9,160 9,950 RCMC4 – Changes identified in the Changes Table as application level C4. • include changes to the safety and/or efficacy aspects of the medicine • require assessment of safety and/or efficacy data (clinical and/or toxicological) to support the proposed changes or a 7 justification for not providing the data
Fees for new complementary medicine ingredients & permitted indications • New ingredients New ingredients Application fee Evaluation fee Total fees ($) ($) ($) IN1 - Evaluation of safety and quality based on international evaluation reports which meet the minimum data 1,050 14,000 15,050 requirements IN2 - Evaluation of safety based on international evaluation reports which meet the minimum data requirements 1,050 14,000 15,050 AND de novo evaluation of quality IN3 - Evaluation of quality based on international evaluation reports which meet the minimum data requirements 2,770 22,900 25,670 or an accepted monograph AND de novo evaluation of safety IN4 - Full de novo evaluation of safety and quality 2,770 22,900 25,670 New permitted indications • – Application fee for new permitted indications $1,020 8
Fees for designation of conformity assessment bodies • Fees for designation - Conformity Assessment Bodies (CABs) to undertake conformity assessment certifications of medical devices Application fee ($) Assessment fee ($) Full designation conformity assessment body determination 4,440 71,700 5,000* 80,000 – 100,000* Partial designation conformity assessment body determination (full QMS) 2,410 51,500 3,000* 60,000-70,000* Partial designation conformity assessment body determination (partial QMS or partial 2,410 51,500 devices) 3,000* 60,000-70,000* * Indicative fees presented in December 2017 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? 13
Recommend
More recommend
