Reforms to the regulatory framework for listed medicines

Reforms to the regulatory framework for listed
medicines
Dr Cheryl McRae
Assistant Secretary, Complementary and OTC Medicines Branch
Medicines Regulation Division, TGA
Complementary Medicines Australia Innovation Seminar and Expo
2 May 2018

Listed medicines regulatory framework
Reforms Implemented already
• application timeframes & categories for ingredient
evaluations for listed medicines
• market exclusivity for new ingredients
• list of permitted indications for listed medicines
• ‘Assessed listed’ pre-market evaluation pathway
Reforms on the way
• Use of comparable overseas regulator reports
• Efficacy assessment ‘claimer’
Reforms to come 1
Complementary Medicines Australia Innovation seminar May 2018

Old (pre-reforms) Listed Medicines Regulatory Framework
Pre-approved
ingredients
Good
manufacturing
practice (GMP)
Pre-
approved/self-
selected
indications
Medicine listed
on the ARTG
Post-market
compliance
2

There are now three pathways for complementary medicines
Australian Register of Therapeutic Goods
(ARTG)
AUST L
Listed medicines
No pre-market evaluation
BUT
• Pre-approved GMP
• Pre-approved ingredients
• Permitted indications
Lower risk
AUST L(A)
Assessed Listed medicines
Pre-market evaluation for:
• Efficacy – Intermediate (&
permitted) level indications
• Optional ‘claimer’
BUT
• Pre-approved GMP
• Pre-approved ingredients
AUST R
Registered medicines
Pre-market evaluation for:
• Quality
• Safety
• Efficacy
• Optional ‘claimer’ ???
Higher risk
3

Listed medicines - Permitted ingredients
Permitted
indications
AUST L
GMP
Pre-approved
ingredients
AUST L
AUST L(A)
• AUST L and AUST L(A) can only use permitted
ingredients.
• All permitted ingredients and requirements contained
in the Permissible Ingredients Determination.
• Ingredients database online: www.ebs.tga.gov.au
• If an ingredient is not currently permitted for use in
listed medicines, sponsors can apply for the substance
to be evaluated.
4

Application categories and timeframes for ingredient applications
Category Description Screening Evaluation
IN1 Evaluation of safety and quality based on evaluation
reports from CORs.
40 70
IN2 Evaluation of safety based on evaluation reports
from CORs
Independent evaluation of quality by the TGA.
40 120
IN3 Evaluation of quality based on evaluation reports
from CORs; or an accepted monograph.
Independent evaluation of safety by the TGA.
40 150
IN4 Full evaluation of safety and quality by the TGA 40 180
5

Use of comparable overseas regulators
6
• We are developing:
– a list of countries and jurisdictions from whom TGA will accept reports
– transparent criteria for and guidance for identifying CORs
– a process for using overseas reports
• Where possible, the TGA makes use of assessment from other
Regulators for evaluation of a substance for use in listed
complementary medicines.
• The TGA is continuing to address the Government’s policy of
accepting ‘trusted international standards and products’ through
implementation of the MMDR reforms.

Criteria for comparable overseas regulators
• The regulator must be an internationally recognised regulatory authority with an
established track record of approving low risk food, chemical or medicinal
substances.
• The regulator must have a transparent system for regulatory decision-making.
• The regulator should have a similar decision-making framework, risk assessment
methodologies and legal responsibilities (including confidentiality and
impartiality) to the TGA.
• The regulator must use internationally accepted scientific standards and
guidelines.
• The TGA must have, or be able to establish, a relationship with the overseas
regulator.
7

Market exclusivity for new ingredients
• A successful applicant for a new permitted ingredient may have
exclusive use of that ingredient for a 2 year period.
• During the specified exclusivity period the use of a protected
ingredient in a listed medicine is restricted to:
– the ingredient applicant
– other persons nominated by the applicant
• At the end of the exclusivity period, the exclusive approval will
revert to a general approval and any sponsor can include the
ingredient in their listed medicine included in the ARTG.
8

When market exclusivity applies
• Exclusivity will only be permitted for a new complementary
medicine ingredient (active or excipient) that is not currently
included in the Permissible Ingredients Determination,
provided that:
 it has not previously been evaluated by the TGA for use in listed or
registered medicines
 it is not used in, or available for use in registered medicines
Complementary Medicines Australia Innovation seminar May 2018 9

When market exclusivity will not apply
• Exclusivity will not apply to applications submitted for a new role or a change
to any existing requirements for use of a permitted ingredient, for example,
applications for:
 A change of permitted use from excipient to an active ingredient
 a change to the permitted level of use (for example, from 0.5% to 1%)
 a change to the permitted route of administration (e.g. from topical use to oral use)
 a change to the permitted use of a herbal ingredient (e.g., a different plant part or preparation
method)
 a change to the requirements to allow use of another strain of a species which is a permitted
ingredient (e.g. addition of the LA-5 strain to Lactobacillus acidophilus)
10

Listed medicines –standard pathway (AUST L)
Permitted indications
• All permitted indications and their requirements are
contained in the Permissible Indications Determination.
New listed (AUST L) medicines can only use permitted
indications.
• 3 year transition period for sponsors of existing listed
medicines.
• Sponsors still required to hold evidence of efficacy
• Process and fee for adding new indications
Permitted
ingredients
GMP
Permitted
indications
11
NEW

Criteria for Permitted Indications
• Permitted indications only refer to:
 health enhancement e.g. ‘Promote healthy digestion’
 health maintenance e.g. ‘Maintain healthy joints’
 prevention of dietary deficiency e.g. ‘Prevent dietary calcium
deficiency’
 a non serious form of a disease or ailment etc. e.g.‘Relieve
symptoms of common cold’
12
An exception to these criteria are sunscreen indications and specific indications linked to
substance-based restricted representation approvals (folic acid, calcium and vitamin D).
Guidelines
on website

Benefits of the list of permitted indications
• Greater transparency for consumers and sponsors and
what is appropriate for listed medicines.
• Avoid consumers from being misled by inappropriate
indications and increase consumer confidence in listed
medicines.
• Reduce the rate of inadvertent sponsor non-compliance.
• The TGA now has the capacity to provide accurate
statistics on listed medicines e.g. traditional products.
13

Summary – Using permitted indications
14
Time of useTarget population
3. Select specifying qualifiers
(Optional)
Sponsors can choose to apply one or more pre-
approved qualifiers from a drop down list.
2. Select core permitted
indication
(Mandatory)
At least one core
indication is selected in
ELF using drop down lists
or key word search.
1. Select tradition of use
(Optional)
Indications that do not
specify a tradition of use
are by default scientific.
Core permitted indication
’Relieves muscle aches
and pains
Specifying qualifiers
Healthy target population: ‘in healthy individuals’
Time of use: ‘after exercise’
Final permitted indication on the ARTG
Relieves muscle aches and pains after exercise in healthy individuals.
Tradition of use
N/A

Including indications on medicine label
• Indications do not have to be included ‘word for word’ on your
label or advertising material.
• However, the intent and meaning of the indication must not change
• i.e. the same therapeutic action and target
For example:
– ARTG indication: ‘Maintain/support gastrointestinal health’
– Label indication - same meaning: ‘Maintains healthy gut’
– Label indication - different meaning: ‘Maintain healthy intestinal flora’

Indications – Type of evidence
Traditional indications Include traditional terms that may be applicable across multiple traditional
paradigms, e.g. ‘cholagogue’, ‘alterative’ ‘adaptogen’ and must be support by
evidence of a tradition of us.
Traditional Chinese
Medicine indications
Contain TCM specific terminology and must be supported by evidence of TCM
use, e.g. ‘Increase Qi flow’
Traditional Ayuvedic
Medicine indications
Contain Ayuvedic specific terminology and must be support by specific evidence of
Ayuvedic use, e.g. ‘Balance Vata
Scientific indications Must be supported by scientific evidence only, e.g. ‘Helps maintain/support bone
mass/density’
Traditional medicines must include a traditional use qualifier in the ARTG and on the product label
16

Assessed Listed Medicine pathway
Intermediate
level
therapeutic
indications
Permitted
ingredients
GMP
• Sponsors self-assess the safety (permitted ingredients) and
quality (pre-approved GMP) of their medicine.
• TGA pre-market assessment of scientific evidence only
supporting efficacy of the indications in finished product.
• Allow higher-level claims (intermediate) which are not
included on the permitted indications list
• Can also include low level indications eg permitted
indications.
• Option to use an efficacy ‘claimer’.
17

Benefits of assessed listed pathway
• Broadens the scope of the listing framework to allow
access to higher level indications than those on the list of
permitted indications
• Encourages industry to improve the standard of evidence
regarding the efficacy of complementary medicines.
• Bridges the gap that exists for industry between the
existing listed and registered medicines pathways.
• Allows greater consumer access to a wider range of
evidence-based remedies to self-manage their health.

Evidence for assessed listed medicines
• Only products supported by quality scientific evidence
for efficacy will be accepted for pre- market assessment
through this pathway.
• Assessment of efficacy data will be based on the
finished product (rather than active ingredients in
isolation) and include a detailed evaluation of evidence
to support all intermediate and permitted indications.
• Guidelines on the evidence required to support
indications for assessed listed medicines are available
on website.
19

Label ‘claimer’
• The MMDR recommended that, where a medicine is
listed in the ARTG under the assessed listed medicines
pathway, the sponsor should be able to indicate on all
promotional materials and on the medicine label, that the
efficacy of the product has been independently assessed
for the approved indications by the TGA.
• The Government accepted this recommendation in
principle, noting that the design and use of promotional
statements will require careful consideration by the TGA
and further consultation with stakeholders
20

Public consultation on a “claimer”
• We will seek feedback on the following:
– the class or classes of medicines that should be allowed to
carry an optional claimer
– options to implement the claimer as a visual identifier and/or
label statement
– how the claimer can be used on medicine labels.
• We will also conduct consumer focus group testing on the
options presented in the public consultation
21

Benefits of claimers
• Allow products that have had their efficacy
assessed to differentiate themselves in the market -
marketing advantage.
• Incentive to increase the evidence base for
complementary medicines.
• Increase transparency for consumers in relation to
the level of assessment for the different ARTG
application pathways.
• Help consumers make more informed healthcare
decisions when self-selecting medicines.
22

Reforms : Next steps
• Public consultation on a claimer
Enhanced post-market monitoring scheme for listed medicines (Rec 49)
 Greater targeting of sponsors with a significant history of non-compliance
 Enforcing sanctions and penalties for repeat non-compliance
 Increase transparency for consumers through publication of review outcomes
 Improved guidance for sponsors about their regulatory obligations
• Revised guidance material
o ARGCM
o Guidance on use of comparable overseas regulator reports
Development of efficacy monographs for commonly used active
ingredients – link with permitted indications.
23

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

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