Background and progress of complementary medicine reforms

Complementary medicines reforms

sponsor education workshops

Background and progress

Michael Shum

Director, Complementary and OTC Medicines Branch

Medicines Regulation Division, TGA

Welcome introduction

Michael Shum – Director, Complementary Medicines Reforms, Complementary and OTC

Medicines Branch

Dr Michael Gardner – Director, Complementary Medicines Evaluation Section,

Complementary and OTC Medicines Branch

2017 Sponsor Education Workshops 1

Agenda

• Overview and update of the progress of complementary medicine reforms – 30 minutes

• Permitted indications – 75 minutes

• Legislative overview

• Transition arrangements

• Applying for new indications

• Break – 15 minutes

• Assessed listed medicines pathway & Evidence guidelines – 60 minutes


Review of Medicines and Medical Devices Regulation

• In March 2015 the Expert Panel conducting the Medicine and Medical Devices Review

(MMDR) made 19 recommendations to improve the regulatory controls for

complementary medicines manufactured, supplied and/or exported from Australia

• In September 2016 the Australian Government released its response and

accepted/supported the intent of all recommendations

• The majority of the reforms outlined in the Response will be implemented between

2018-2019.


Five streams of work

Enhancing the listing framework Stream 1

Increased flexibility for sponsors and improving the evidence base Stream 2

Improving transparency for consumers Stream 3

Increased predictability for industryStream 4

Enhanced post-market monitoring and compliance actions

Stream 1

Stream 2

Stream 3

Stream 4

Stream 5


Principles guiding complementary medicine reforms

• Maintain confidence in TGA regulation of complementary medicines

• The level of regulation of medicines is commensurate with risk

• Transparency on the level of assessment undertaken by the TGA and avoid consumers being

misled by medicine indications

• Improve sponsor compliance with regulatory requirements

• Clear guidance on application processes and requirements

• Support innovation and increase the evidence base and the standard of evidence for

complementary medicines

• Enable higher level indications to be made for listed medicines where that medicine’s evidence

has been evaluated by the TGA


Implemented reforms

• In March 2017, the online catalogue of ingredients approved for use in listed

medicines was implemented.

• From 1 July 2017, sponsors who lodge applications for evaluation of new

ingredients for use in complementary medicines are able to apply for review and

appeal of decisions relating to those assessments.


Staged implementation – indicative timeframes

By 2018

– Permitted Indications

– Market exclusivity for newly approved ingredients for applications submitted from January 2018

– Risk-based approach to medicine variations

By 2019

– Assessed listed medicines pathway launched

– Label ‘claimer’

72017 Sponsor Education Workshops

Consultations

• Targeted stakeholder consultations commenced October 2016

• Public consultations throughout 2017

• Consultation outcome available at MMDR public consultation

forecast on the TGA website

• More consultation to come in 2018

2017 Sponsor Education Workshops

8

https://www.tga.gov.au/implementation-reforms-public-consultation-forecast

First consultation on complementary medicines

• A list of permitted indications for lowest risk medicines

Recommendation 38

• Introduce a three-tiered risk-based framework

Recommendation 39

• Allow sponsors to claim their medicine has been assessed for efficacy

Recommendation 45

• Incentivise industry innovation

Recommendation 50


Consultation outcomes

• Introduce permitted indications to limit the indications that can be made for

listed medicines

• Providing a 2 year period of protection for new ingredients approved for use in

listed medicines

• Introduction of a new pathway for assessed listed medicines will sitting between

the existing listed and registered pathways

• Further consultation required to finalise the label ‘claimer’


Overview of complementary medicines reforms

Premarket evaluation for:

• Quality

• Safety

• Efficacy

• Can use ‘claimer’ (Rec 45)

Registered medicines

AUST R

Premarket evaluation for:

• Efficacy – Intermediate level

indications

• Can use a ‘claimer’ (Rec 45)

BUT

• GMP

• Pre-approved ingredients

Assessed Listed medicines

AUST L(A)

No premarket evaluation BUT:

• GMP

• Pre-approved ingredients

• Permitted indications

Listed medicines

AUST L

Australian Register of Therapeutic Goods

(ARTG)

Higher riskLower risk


Second consultation on complementary medicines

• Expanding the sources of evidence for ingredient assessments

Recommendation 35

• Use of reports from comparable overseas regulators

Recommendation 36 and 40

• Legislative timeframes for pre-market assessments

Recommendation 41

• Enhanced post-market compliance scheme

Recommendation 49


Key features: Acceptable sources of evidence

for de novo assessment

• Criteria developed to confirm that there is sufficient similarity between a source of

evidence and TGA requirements

• A list of acceptable sources of evidence will be published on the TGA website

• The source of evidence must be in English, peer reviewed and consistent with the

current body of knowledge. Any conflicts must be identified.

• The way in which the submitted evidence source is developed must be consistent with

internationally recognised guidelines and standards


Recommendation 36 and 40 - Methods for assessment

Current situation

• Only accept data for de novo assessment

Changes proposed under recommendations 36 and 40

• Allow use of evaluation reports from comparable overseas

regulators in addition to de novo assessment

• Increased flexibility by allowing a combination of de novo and

overseas assessment


Recommendation 41: Key Features

• Timeframes for premarket assessments will be included in the legislation

– Applications will have different assessment timeframes depending on the information

to be evaluate

– Partial refund of fees if evaluation timeframes are not met

• A standard application and evaluation process for all pre-market assessment

Pre-submission

meetingSubmission Screening Evaluation Decision Implementation


Recommendation 41: Key Features

• Introduction of new risk based application categories for

– ingredient assessment

– the assessed listed medicines pathway

– registered medicines pathway

• Application categories to allow for use of international evaluation reports and de novo

assessment

• A new fee structure that is commensurate with the amount of work required

– the new structures moves away from a page count


Consultation outcomes

• The Consultation on Business Process Improvements supporting

Complementary Medicines Assessment Pathways closed on 7 November

2017

• 14 submissions received

• Submissions will be analysed and outcomes reported back to the Minister

• TGA’s response to the consultation submissions will be published on the TGA

website in the coming months

• Responses indicate a general support for the proposed timeframes and

application categories

– some concern surrounding the fees and criteria for use of overseas reports

– clarity sought on the legislated timeframes and submission process2017 Sponsor Education Workshops 17

Next steps

• Legislative amendments to the Therapeutic Goods Act 1989 and the

Therapeutic Goods Regulations 1990

• Further consultation

• Sponsor education

• Updated guidelines


Questions


Background and progress of complementary medicine reforms

Health & Medicine

Transcript of Background and progress of complementary medicine reforms