Presentation: Overview - Regulatory Obligations Seminar

Reforms to the Regulation of
Complementary Medicines
Lyndall Soper
Assistant Secretary, Complementary and OTC Medicines Branch
Medicines Regulation Division, TGA
Complementary Medicines: Regulatory Obligations Seminar
11 April 2017

Review of Medicines and Medical Devices Regulation
July 2015 - MMDR review was released by Expert Panel
 19 recommendations to improve the regulation of
complementary medicines
15 September 2016 - Government response released
 accepted the majority of the review’s
recommendations in full or in-principle
 identified the need for consultation with stakeholders
in progressing the reforms.
1

5 streams of work
Enhancing the listing frameworkStream 1Stream 1
Improving transparency for consumersStream 2
Increased flexibility for sponsors and improving the evidence baseStream 3
Increased predictability for pre-market approvalStream 4
Enhanced post-market monitoring and compliance actionsStream 5
Stream 2
Stream 3
Stream 4
Complementary Medicines: Regulatory Obligations Seminar 2

Stream 1: Enhancing the listing framework
Recommendation Government Response
Recommendation 34
Capacity to refuse to list
Supports the intent of recommendation
Recommendation 37
Online searchable catalogue of permissible
ingredients
Accepts recommendation
Recommendation 38
Establish a list of permitted indications
Accepts recommendation

Recommendation 37: Catalogue of Permissible
Ingredients
Recommendation 37
The Panel recommends that the TGA develop and maintain a real time, readily
accessible catalogue of approved ingredients for use in listed medicinal
products.
Government response
The Commonwealth accepts Recommendation Thirty-Seven, as it will provide a
single readily accessible list of ingredients for sponsors and the general public,
minimising unnecessary regulatory burden.

Recommendation 37 – Key Features
• All listed medicine ingredient information and
associated restrictions now available in a single
online database
(before they were in 6 volumes of PDFs on FRLI)
• Updates to the online database will be made to
match updates to the Permissible Ingredients
Determination
• Ability to conduct searches using ingredient
information such as; synonym terms, key words

Recommendation 37: Key Features
• Enhancement of Ingredient Table search results to make it more obvious where
to find detailed ingredient information:
- Hyperlinks
- Less clicking for users
• Improved access to the Ingredients Table:
- Direct link from the TGA homepage to Ingredient Table search

Stream 2: Improving transparency
Recommendation 43
Requirement to publish efficacy evidence
Supports the intent of the recommendation
Recommendation 44
Publication of disclaimers on promotional material
where product has not had efficacy assessed
Supports the intent of the recommendation and will
conduct further consultation on ways to better educate
consumers however the Government will not require
sponsors to place a disclaimer on product labels
Recommendation 45
Publication of a ‘claimer’ where product has had
efficacy assessed by TGA
Accept in principle
Recommendation 46
Adopt or develop evidence monographs
Accepts the recommendation

Recommendation 46: Efficacy Monographs
Recommendation 46
The Panel recommends that the NRA develops or adopts from comparable
overseas regulators, efficacy monographs for commonly used active
ingredients that have been approved for use in listed medicinal products.
Government response
The Commonwealth accepts Recommendation Forty-Six, as the development or
adoption from comparable regulators of monographs has the potential to improve
the availability and accuracy of information for consumers and to reduce time and
costs for industry.

Who Will use Monographs?
TGA efficacy monographs for complementary medicines may be used by:
• SPONSORS of low risk medicines as a primary source of evidence to support
permitted indications.
– If fully compliant with a monograph, a sponsor will not be required to hold an
evidence package for their medicine.
• CONSUMERS as a reliable and trusted source of information to inform their
medicine choices.
• OTHER REGULATORS as a reliable and trusted source of information.

Monographs – Next Steps
Monographs could be developed in a number of ways:
• Adoption of monographs of comparable regulators in full
• Adoption of monographs with a TGA annotation
• Developing our own TGA monographs
Candidate ingredients for monograph development could be based on e.g.,
top ingredients included in the ARTG, top selling products.
Further targeted consultation with industry is planned to help refine priorities for
adopting or developing monographs and the approach to their development

Monographs
Benefits for Industry
 Sponsors that complied with ingredient based monographs would not
be required to hold an evidence package
 Considerable savings for small to medium sized sponsors
 Provide a level of assurance to all sponsors that the evidence for
indications on their product are sound

Stream 3: Increased Flexibility for Sponsors and
improving the evidence base
Recommendations 35 and 36
Continue to evaluate ingredients on safety, evidence and quality
with two methods for assessment of new ingredients
Accepts both recommendations
Recommendation 39
Three pathways for inclusion of listed medicines on the ARTG
Recommendation 40
Develop two pathways for registered complementary medicines

Recommendations 35 & 36: Assessment of new ingredients
Recommendation 35
The Panel recommends that the TGA continues to evaluate ingredients for use in listed
medicinal products and should continue to give consideration to:
A. the safety of the proposed ingredient
B. working with stakeholders to identify a broader range of appropriate sources of
evidence
C. the quality of the proposed ingredients.
Government response
The Commonwealth accepts Recommendation Thirty-Five, noting that stakeholders were
in favour of the TGA continuing to evaluate ingredients for use in listed medicinal products.

Recommendations 35 & 36: Assessment of new ingredients
Recommendation 36
The Panel recommends that a sponsor seeking to have a new ingredient assessed by
the TGA for use in listed medicines, is able to either:
A. submit data relating to the safety and quality of the proposed ingredient for use in listed
medicinal products for de novo assessment by the NRA; or
B. B. submit an un-redacted evaluation report from a comparable overseas regulator
Government response
The Commonwealth accepts Recommendation Thirty-Six, as it will provide additional
flexibility for applicants looking to apply for assessment of new ingredients for use in
listed medicines.

Methods for assessment of new ingredients
Current situation
• Only accept data for de novo assessment
Changes proposed under Recommendations 35 & 36
• 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 (noting the difficulty of finding comparable
overseas regulators who could provide a total report)
• Explore options for expanding the range of acceptable evidence
(monographs from suitable regulators, WHO, EFSA etc)

Recommendations 40: Comparable overseas regulators for
Registered Complementary Medicines
Recommendation 40
The Panel recommends that where a sponsor seeks to include a complementary medicinal
product in the ARTG that the sponsor is able to do so utilising registration Pathways One or
Two, namely
A. Submission of a complete dossier for de novo assessment
B. Submission of an un-redacted evaluation report from a comparable overseas NRA
Government response
The Commonwealth accepts Recommendation Forty, as it will increase flexibility for
sponsors seeking to register a complementary medicine in the ARTG.
16

Methods for assessment of Registered Comp Meds
Current situation
• Only accept data for de novo assessment of RCMs
Changes proposed under Recommendations 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
(noting the difficulty of finding comparable overseas regulators
who could provide a total report on quality, safety and efficacy)

Stream 4: Increased predictability for pre-market approval
Recommendation 41
Develop legislative timeframes for premarket assessment
Recommendation 42
Management of variations
Recommendation 47
Expand review and appeal rights
Supports the intent of the
recommendation
Recommendation 50
Incentives for innovation of complementary medicines
Accepts in principle

Recommendation 41 – Legislative timeframes
Panel recommendation:
In consultation with industry, develop legislative timeframes for the:
• assessment of new ingredients for use in listed medicinal
products;
• publication of finalised compositional guidelines for newly
approved ingredients for use in listed medicinal products,
where appropriate;
• assessment of medicinal products listed under the new
pathway
• registration of complementary medicines
19

Recommendation 41 – Legislative timeframes
Government response
The Commonwealth accepts Recommendation Forty-
One, noting that development of legislative timeframes
will be subject to further consultation with stakeholders.
How will we will do this?
• Development of risk based application categories
for pre-market assessed complementary medicines
• Implementation of associated timeframes and fees
20

Recommendation 47 – Review and Appeal Rights
Panel Recommendation:
In revising the Therapeutic Goods Act 1989 and subordinate legislation, the
Australian Government provides review and appeal rights for the sponsor who has
lodged an application for a new ingredient (to be approved for a listed medicine) to
seek a review of an NRA decision regarding that application.
Government response:
The Commonwealth supports the intent of Recommendation Forty-Seven. The
design of potential review and appeal rights requires careful consideration of the
application of administrative law principles in this context.
21

Recommendation 47 – Review and Appeal Rights
22
Process
Application for
new ingredient
Included in permitted
ingredient list
ApprovedInitial decisionEvaluation
Refused
Appeal made by applicant
to Minister
Internal review
Administrative Appeals
Tribunal
Amendments to the Therapeutic Goods Act to implement review and appeal rights are currently before Parliament.

Stream 5: Enhanced post-market monitoring and
compliance actions
Recommendation 49:
Post market monitoring scheme
Accepts the recommendation;
noting that the intent of some
elements of the recommendation can
be achieved within existing
mechanisms

Recommendation 49 – Enhanced Post Market Monitoring
Panel Recommendation:
A more comprehensive post-market monitoring scheme for listed medicinal
products, including complementary medicinal products. Such a scheme should
include:
• an increase in the number of products subject to random/targeted reviews
• integration of available datasets, including eHealth and hospital records, to
provide a more streamlined and cost effective approach to post-market
monitoring
• provision for electronic reporting of adverse events; and
• enhanced collaboration with overseas NRAs to share information relating to
safety or efficacy of comparable products.

Recommendation 49 – Enhanced Post Market Monitoring
Government response:
The Commonwealth accepts Recommendation Forty-Nine, as the development of
a more comprehensive post-market monitoring scheme will enhance consumer
protection and complement existing post-market monitoring processes.
How are we going to do this?
• Increase the number of compliance reviews completed each year
• Using information from available datasets to better target areas of known non-
compliance
Complementary Medicines: Regulatory Obligations Seminar – 11 April 2017 25

Indicative timeframes of all the Recommendations
Phased implementation in the next 12 to 24 months
By 12 months
• An online catalogue of ingredients approved for use in listed medicines
• Permitted indications
• New assessment pathways for registered complementary medicines and new ingredients
• Risk-based approach to medicine variations
By 24 months
• New listing pathway
• Label claimer

Legislation Process
• Delivery of many reforms is dependent on passage of legislative amendments
and regulatory changes
• First set of legislative amendments (Bill 1) introduced to Parliament in late 2016
– changes to come into effect in June 2017
– some focus on creating regulatory-making powers
• Second set of amendments (Bill 2) focus on reforms to come into effect in 2018

Legislation Process
• Need for legislation identified
– Consultation
– Regulation Impact Statement
– Policy approval
• Preparation of a ‘Bill’
– Drafting instructions
– Ministerial Clearance
– Preparation of supporting materials
• Legislation approval process
Draft Bill
House of Representatives
Bill presented
First reading
Second reading (in principle debate)
Consideration in details
(amendments may be made)
Third reading
Senate
Similar process to the House of
Representatives
Governor-General
Assent

MMDR consultations
• Targeted stakeholder consultations commenced October 2016.
• Public consultations proposed throughout 2017.
• The proposed reforms arising from recommendations 38, 39, 45
and 50 are addressed in our first public consultation paper.
• Other MMDR recommendations relating to complementary
medicines will be the subject of consultation in late 2017.
• See the MMDR public consultation forecast on the TGA website
for further information.

First consultation:
Complementary medicine assessment pathways
• A list of permitted indications for lowest risk medicines
Recommendation 38
• Introduce a new middle pathway to make 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 Submissions
A total of 58 submissions were received in response to public consultation, which
comprised:
 20 submissions from industry
 4 submissions from peak industry bodies
 13 submissions from healthcare professional bodies
 3 submissions from academic institutions
 4 submissions from consumer and other professional bodies
 6 submissions from practitioners
 6 submissions from individuals
 2 submissions from government agencies

Consultation Responses
The outcomes of analysis of the submissions from the public consultation show
that:
• The majority support the introduction of a new pathway
• A large majority supported the criteria proposed for indications and the claimer
• A large majority support innovation for the complementary medicines sector
whether this is via market exclusivity for new ingredients or data protection for
efficacy data on the finished product formulation

Next steps
• Legislative amendments to the Therapeutic Goods Act 1989 and the
Therapeutic Goods Regulations 1990
• Further consultation
• Transitional arrangements
• Sponsor education
• Updated guidelines

Questions?
Complementary Medicines: Regulatory
Obligations Seminar
34

Find out more:
www.tga.gov.au/mmdr
MMDR.consultation@health.gov.au

Presentation: Overview - Regulatory Obligations Seminar

Presentation: Overview - Regulatory Obligations Seminar

Empfohlen

Empfohlen

Weitere ähnliche Inhalte

Was ist angesagt?

Was ist angesagt? (20)

Ähnlich wie Presentation: Overview - Regulatory Obligations Seminar

Ähnlich wie Presentation: Overview - Regulatory Obligations Seminar (20)

Mehr von TGA Australia

Mehr von TGA Australia (20)

Kürzlich hochgeladen

Kürzlich hochgeladen (20)

Presentation: Overview - Regulatory Obligations Seminar

Hinweis der Redaktion