صفحه 1:
صفحه 2:
ontrol of Quality and Safety c
Traditional Medicines and
Health Supplements -
he Australian Experienc
National Pharmaceutical Control
Bureau
Ministry of Health Malaysia
Val Joh AAD ARY RO Ind Associates
Consulting
صفحه 3:
Overview
“i The Australian regulatory
framework
۱۲ The Australian market
“ The Australian Experience
صفحه 4:
اب ۶۶۱۸5
a supp pPlements
medicines are regulated as
complementary medicines in Australia
= Include:
> vitamins
> minerals
> nutritional supplements
» e.g.glucosamine and chondroitin
> herbal remedies
> sports supplements
> homoeopathic products
صفحه 5:
KHeGuiation or
Supplements
Australia has a strict regulatory system
@risk based
@leads the world
@based on a pharmaceutical regulatory
approach
@pharmaceutical manufacturing
standards
صفحه 6:
2 2 2 2
Principal Legislation
= Implemented in February 1991
= Therapeutic Goods Act 1989 and
amendments
= Therapeutic Goods Regulations
= Supported by-
- Therapeutic Goods Orders
: for example - Labelling Order, Pills, Tablets
and Capsules
- Standard for Uniform Scheduling of Drug:
and Poisons
- Guidelines
: for example - AGRCM
a ee Oe ا
صفحه 7:
Objective of
Legislation
“ To provide a system of controls
over the quality, safety and
efficacy of medicines including
health supplements and
traditional herbal medicines and
to ensure their timely
avatlahilitv’
صفحه 8:
۱۷۷۸۲۲
Medicines
A complementary medicine is defined
as:
“a therapeutic good consisting
wholly or principally of one or
more designated active ingredients,
each of which has a clearly
established identity and:
(a) a traditional use; or
(b) anv other use prescribed in
صفحه 9:
Traditional Use
- “is well documented or otherwise
established, according to the accumulated
experience of many traditional health care
practitioners over an extended period of
time; and
- accords with well established procedures
of preparation, application and dosage.”
صفحه 10:
اه ۸۵ هت )۶
Ingredients
Listed in the regulations and include:
~ amino acids
- charcoal
- choline salts
~ essential oils
- plant or herb material (or their synthetic forms)
- homoeopathic preparations
- microorganisms (other than vaccines)
- minerals including salts
- mucopolysaccharides
- non human animal material (or synthetic form)
- lipids
- bee products
- sugars, polysaccharides or carbohydrates
- vitamins or provitamins
صفحه 11:
Herbal Medicines
Definition of ‘herbal substance’ -
“all or part of the plant or substance (other than a pure
chemical or a substance of bacterial origin):
(a) that is obtained only by drying , crushing, distilling,
comminuting, mixing with an inert diluent substance or another
herbal substance or mixing with water, ethanol, glycerol or
aqueous ethanol, and
(b) that is not subjected to any other treatment or process other
than a treatment or process that is necessary for its presentation
in a pharmaceutical form.”
صفحه 12:
Essential Regulatory
Elements
B Pharmaceutical manufacturing standards
Bf Register of therapeutic goods
B Positive list of low risk ingredients
B® Expert Evaluation Committee
Bf Advertising Code
© Post market surveillance
B Adverse reporting system
صفحه 13:
Risk Based System
The Australia regulatory system
recognises the low risk nature of
supplements and herbal remedies
and this is reflected in the level of
regulation that applies to these
products
صفحه 14:
Register of
Therapeutic Goods
BAll products must be registered before they can be
legally manufactured, exported, imported or supplied in
Australia and included in the Australian Register for
Therapeutic Goods
Two registration categories
Wlow risk listable products
Whigher risk registerable products
صفحه 15:
Low Risk Category
Listable products are self assessed
*low risk products containing low risk ingredients and making
lower level therapeutic claims
» sophisticated electronic lodgement system
»validate application details and lodge electronically
> certification of compliance
> quick turn around time
»AUST L number in 48 hours after payment received
*go to market as soon as get labels printed
low registration fee $490 and annual charge $530
صفحه 16:
۶ 51۷/۵ list OF
Ingredients
BListable complementary medicines can contain only low
risk permitted ingredients
BThousands of ingredients permitted under law
Permission based either on long history of safe use in
Australia or have been evaluated for safety by the expert
committee
۲ New ingredients must comply with the definition of
complementary medicine and must be evaluated for
safety and approved by the Expert Committee
صفحه 17:
Claims for Listed
Products
Low risk listable products can only make less serious
claims
»symptomatic relief of non serious diseases or conditions
»health maintenance
>health enhancement
>risk reduction
> nutritional support
> may assist in the management of non serious diseases or
conditions
صفحه 18:
1۳۷1616166 TO ۴
Claims
B® Legal requirement for the company to hold evidence to
support the claims they make for their product
Stronger evidence is required for stronger claims
BThe TGA has developed a Guideline for Levels and
Kinds of Evidence to Support Indications and
Claims
BThe TGA can call for the evidence if there is a complaint
about a claim or as part of their post market
surveillance
صفحه 19:
1۲۸14716۲ ۲۸5۳۲ 212091
BRegisterable products must be fully evaluated by
expert committee
Higher risk products containing more toxic
ingredients or making higher level therapeutic claims
Blonger process
Bmore expensive-
&$780 application fee plus $5000-$36000 evaluation fee anc
higher annual charges
صفحه 20:
ware a a
B‘High’ level oo LOCMUCKS...... risk products
but must be evaluated and approved by the Expert Committee
before the products can be registered, advertised or marketed
BHigh level claims include:
Bclaims for treatment, cure or management
BPrevention
WReference to serious conditions or diseases
Better quality evidence is required to substantiate high level
claims as identified in the Guideline
صفحه 21:
Medicines
Evaluation
‘vince HO MAMILECe ا
BMembers include expertise in:
complementary medicine, general practice, herbal medicine, nutrition,
pharmacognosy, pharmacology, toxicology, naturopathy, regulation and
a consumer
Responsible for evaluating and providing advice:
registerable complementary medicines
Mew ingredients
Bother matters referred by the Minister
صفحه 22:
1۱۷ ۰۳۸۸۸۴ ۸۶ ۱۸۸ و ۶
Poisons Schedule
Committee
Bf Expert Government Committee with members appointed by
the Minister of Health
Responsible for:
Wclassifying and scheduling substances (drugs and poisons) according
to their toxicity
B providing advice on legislative restrictions and labelling, packaging
and advertising of scheduled substances (drugs and poisons)
Bconsidering matters referred by the Minister
صفحه 23:
Manuracturing
هت 3۳05 to bring
the product to their final state
Australian Code of Good Manufacturing Practice
(GMP) is based on the EU/PICS for
pharmaceuticals
Australian manufacturers must be licensed by
TGA to carry out the specific step in manufacture
BInternational manufacturing facilities must be
audited and approved by the TGA
صفحه 24:
Licensable steps
Includes raw materials as well as finished product
> processing
> assembling
> packaging
> labelling
> storage
> sterilising
> testing raw materials
> testing finished product
> releasing for supply
صفحه 25:
Quality
Information is required to determine the quality of
products including identity and impurities:
*active ingredient specifications
*identification and validation of the ingredient-
particularly herbal ingredients
» batch certificates of analysis
analytical procedures and validation
EStability data are required to justify a shelf life and
to identify any degradants
صفحه 26:
Complementary
Medicines
WAIl Advertisements for complementary Medicines are
required by law to comply with the Therapeutic Goods
Advertising Code
BTherapeutic Goods Advertising Code Council
> aco-regulatory committee
»comprises industry, practitioners, consumers and regulators
»responsible for updating the Code and
صفحه 27:
What is an
Advertisement
The definition of advertisement is very broad
and means:
“any statement, pictorial representation or
design, however made, that is intended whether
directly or indirectly, to promote the use of
supply of the goods”
صفحه 28:
Complementary
Medicines
Products can be advertised ONLY
for the therapeutic claims or
indications that have been included
in the Register for that product
صفحه 29:
Therapeutic Goods
Advertising Code
BProvides the rules for advertising therapeutic goods
including supplements and herbal medicines to the public
BObjective is to ensure that the advertising:
is socially responsible
»promotes the quality use of medicines
» does not mislead or deceive the consumer
صفحه 30:
Approval of
Advertisements
Advertisements for radio, TV, newspapers or
magazines must be approved before publication or
broadcast
B Point of sale information and other promotional
material including Internet does not require approval
but must comply with the Code and the legislation
صفحه 31:
Complaints
B® Complaints about advertisements can be made
by the public or by other companies
EB Complaints from main stream media are
handled by a co regulatory Complaint Panel
BIf the complaint is upheld the Panel can:
> ask for the advertisement to be withdrawn
»ask for a public retraction statement in the same
media
»refer it to the TGA for cancellation of product or
prosecution
EB Complaints about other promotional material
are handled by the peak industry organisations
صفحه 32:
Adverse Reaction
Reporting System
BAll serious reactions to medicines should be
reported to the TGA
EB These are considered and evaluated by the
Adverse Drug Reaction Advisory Committee to
assess causality, note any trends and make
recommendations to the TGA and the Minister
B Under GMP companies are required to keep a
record of all adverse reactions that are reported
records inspected at GMP audits
صفحه 33:
Post Market
همم 6۱۵1۵۸66۰ up
the self assessable electronic registration system and
provides confidence to consumers and the regulators on
quality, safety and efficacy
BPMS action includes:
> targeted and random desk based audits (records and info)
monitoring suspected adverse reactions
> targeted and random laboratory testing of final product and ingredients
>Targeted and random surveillance in the market place
> Effective and timely recall procedures
Regular GMP audits
صفحه 34:
Self Regulation
Bindustry Codes of Practice for:
» Marketing and Advertising
» Raw Materials
> Sports Supplements
BComplaint Resolution Committees that deals with
complaints
Work with Education and Research institutions
B Industry consults with the Regulatory Bodies to
ensure that regulation is appropriate and effectiv
صفحه 35:
Australia Jo Zealand Age! a icy establish a
Joint Regulatory system
BJoint regulatory office to administer the system
Same basic elements as the current Australian regulatory
system
» Pharmaceutical GMP, product licence, Register of products, positive
list of safe ingredients, advertising code
BThe new regulatory system with New Zealand is expected to
allow more low risk ingredients
B New Agency expected to open its doors in mid 2005
صفحه 36:
Australian Market
® Over 1AUD$ billion market
®Market growing around 15% per year
Sold through:
- Health Food Stores
- Pharmacy
- Supermarkets
- Mail Order/Internet
- Direct selling (door to door)
- Health practitioners
صفحه 37:
Australian Industry
& 4 or 5 big brand companies
> many small companies
۲ 3-4 big manufacturers
> several small
B Mostly contract manufacturers
® Manufacturers are world standard,
high quality and TGA licensed
®Common market with New Zealand
in mid 2005
صفحه 38:
Consumer Use
mOver 60% of Australians take
supplements
—& Nearly 60% of Australians prefer to take
a natural product before a pharmaceutical
product
“In a healing profession obsessed with
intervention, invasive technology and drug
management, the practitioner has an
obligation to his or her patients to use
natural healing methods wherever
possible, and be very discerning and
صفحه 39:
2110011 ,5 ۶۶۸ ۸۸6۶ از
Experience
= The Australian Regulatory framework for
natural health products leads the world
=It is a good system that:
» recognises the low risk nature of natural
health products
> allows therapeutic claims where they can be
justified
» enables fast product registration and access
to market
» provides consumer confidence that the
products are high quality, low risk and are
efficacious
a ی هد
صفحه 40:
Terminology
= The term ‘complementary medicine’ is
not understood by consumers
«Industry prefers ‘natural health products’
as Canada uses
= Consumers use these products because
they are ‘natural’
صفحه 41:
Administration
= An office of Complementary Medicine
within an Administration that is staffed by
pharmaceutical and medical experts
brings some challenges and difficulties
resulting from a medico-pharmaceutical
mindset and culture
«There is a clear need for regulatory
officials who are responsible for
interpreting and administering regulations
for natural health products to be educated
and have expertise in natural healthcare
صفحه 42:
Role of the Peak
Industry Association
= A positive and constructive relationship
between the peak industry body and the
regulator can achieve much providing a
win/win outcome
«The CHC is the peak industry body for CM
in Australia and has been extremely
successful and responsible for major
changes to the regulatory environment for
Complementary medicines
صفحه 43:
Some Achievements
of the CHC
= Establishment of the CM Evaluation
Committee
= Approval of first new CM ingredients
(after 9 years)
= Review of the advertising rules to allow
more meaningful claims
= Establishment of an Office of CM within
the TGA
= Development of Guidelines for Levels of
Evidence
a ee eee Oe MUR Be ce ee, ee al
صفحه 44:
Consultation
The ‘partnership’ approach that
allows constructive consultation with
industry has been invaluable and
allows industry to contribute to the
debate and decision making process
prior to legislative change
صفحه 45:
In Summary-
Australian made supplements and herbal products are
high quality, low risk and efficacious due to:
>A stringent regulatory system
>Pharmaceutical manufacturing standards
>Registration before being manufactured, going to market or
being exported or imported
>Post market surveillance
>Advertising controls
>Good quality herbs and herbal extracts
>Clean and green environment
صفحه 46:
More Information
TGA website
= www.tga.gov.au
=Complementary Healthcare Council
of Australia
= www.chc.org.au
= Johanson and Associates website
=www.nhm.johanson.com.au