4. Two categories of Medicinal
Products in Australia :
1. Medicines (such as Prescription drugs
and Vitamins)
2. Medical Devices (such as heart valves)
5. Pricing and state funding
• Major part of Australia's healthcare system is
called Medicare. It is financed from general tax
revenue.
• National funding is provided through:
1. Subsidies for prescribed medicines
2. Free or subsidised treatment by medical
practitioner
3. Grant for free access to public hospital
4. Specified purpose grant to state and territory
governments and other bodies
6. pharmaceutical Benefit Scheme (the PBS)
subsidizes the cost of prescribed medicines, OTC
medicines is not regulated.
If a pharmaceutical supplier wishes to have a
new drug listed on the PBS it must make an
application to the department of Health and
Ageing. Here are considerations for a new drug
to be in the listing for the PBS:
7. 1. Whether the drug is needed for the
prevention or treatment of a medical
conditions not already covered by drugs
already listed
2. Whether the drug is more effective and/or
less toxic than the drug already listed for the
same indications
3. Whether the drug is at least as effective and
safe as a drug already listed for the same
indications
8. Recommended price for the
manufacturer by the
PBPA(pharmaceutical benefit pricing
authority) is based on :
• Price of alternative brands
• Price of other drugs in the same therapeutic group
• Cost data information
• Overseas price
• Prescription volume
Then the PBPA(pharmaceutical benefits pricing authority
) undertakes negotiations with the supplier and this is
sent to the minister of health and ageing for approval.
9. Manufacturing
• Application : is submitted to the TGA for a license
• Conditions : complying with the TG Act, GMP,
also ICH guidelines
• Restrictions on foreign applicants : providing
acceptable standard and GMP evidence
• Key stages and timing : compliance with GMP codes is
checked through regular audits by the TGA. These can
take from less than a day to up to 4 days
• Period of authorization and renewals : a licence
remains in force until it is suspended, cancelled, or
revoked
10. Clinical Trials
1. Clinical Trial Exemption Scheme (CTX
Scheme) : an approval process that the
sponsor of clinical trial submits an
application to conduct clinical trial to the TGA
2. Clinical Trial Notification Scheme (CTN
Scheme) : all materials relating to the trial
protocol are submitted directly to the Human
Research Ethics Committee(HREC) by the
researcher at the request of the sponsor
11. Marketing
• Application : marketing applications for medicinal
products must be made to and approved by the TGA
• Conditions : complying with Therapeutic Goods
Orders(TGOs), British Pharmacopoeia( BP), the
European Pharmacopoeia(Ph Eur),and USP
• Key stages and timing : the registration process
involves a detailed review by the TGA of the quality,
safety, and efficacy of the medicinal products in
question.. The TGA must decide to accept or reject the
application within 40 working days
• period of authorisation and renewals : medicines
remain listed or registered until their listing or
registration is cancelled
12. Advertising
Advertisement for medicinal products are subject to :
• The TG Act and subordinate regulations
• The Trade Practice Act(TPA)
• Other applicable state and territory legislation
depending on the form and location of the
advertisement
• The TGAC(therapeutic goods advertising code) (for
advertisements directed to consumers only)
It may only refer to the indications for specific product
13. Advertising prescription products
directly to consumers is prohibited
OTC products may be advertised to the general
public, subject to requirements in :
• The TG Act
• The TG regulations
• Relevant state and territory legislations
• The TGAC (therapeutic goods advertising
code), which sets out specific requirements on
the content of advertisement for medicinal
products
14. Packaging and labeling
Packaging must comply with the following
(depending on the product) :
• The TG Act
• The TG regulations
• Relevant state and territory medicinal products
legislation
• Therapeutic Goods Orders 69(TGO 69) on general
requirements for labels for medicines
• TGO 37 on general requirements for label for
therapeutic Devices
• The TGA for non-prescription medicines
15. Traditional herbal
medicines
The manufacture and marketing of traditional
herbal medicine is regulated by the TG Act, TG
regulations and SUSDP ( Standard for the Uniform
Scheduling of Drugs and Poisons)
Whether a herbal medicinal product is listed(low
risk) or registered (high risk) depends on :
• The indications granted for the product by the
TGA
• The product's ingredients
• The claims made by a sponsor on the product's
labeling
16. Patents
Pharmaceutical and biotechnology products and
processes, medical devices and methods of medical
treatment are all patentable, provided they are all
of the followings :
• A manner of the new manufacture ( a threshold
test requiring the invention to be appropriate for
a patent)
• Novel
• Inventive
• Useful
17. • The authority : applications are
Made to IP Australia (intellectual property)
• Fee : between $6000 and $10000
• Process and timing : process starting by filling
of either a complete specification or a
provisional specification (must be filed within
12 months)
• Duration of protection : 20 years from the
date of filling unless they lapse through failure
to pay renewal fees or are revoked
18. • Renewal process : annual maintenance fees
are payable from the 5th anniversary of the
filling of the complete satisfaction for a
standard patent and from the second
anniversary of an innovation patent
• Currently maintenance fees for a standard
patent amount to about $8000 over the 20
year term of a patent
19. Trade Marks
To qualify as a trade mark, a sign must be used
or intended to be used to distinguish goods or
services dealt with or provided in the course of
trade.
To register a trade mark :
• The authority : application are made to IP
Australia
• Fee : currently is $120
20. • Process and timing :
Application must be made on the prescribed
form, which must specify the goods and /or
services in respect of which the applicant wishes
to register the trade mark. the period of time is
depending on the number of applications
• Duration of project : 10 year period from the
filling date
• Renewal process : it can be renewed within
12 months before or after the expiry date of
the mark
21. Product liability
• Legal provisions : Australia's product liability
laws are a mixture of common law and various
federal , state and territory statutes.
