Australia Regulatory overview

• The TGA• Pricing and state funding• Manufacturing• Clinical trial• Marketing • Advertising • Packaging and Labeling• Traditional Herbal Medicines• Patents • Trade Marks• Product liability

Therapeutic Goods Administration(TGA)

• TG Act is administered by a federal agency called TGA.

Two categories of Medicinal Products in Australia :

1. Medicines (such as Prescription drugs and Vitamins)

2. Medical Devices (such as heart valves)

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 medicines2. Free or subsidised treatment by medical

practitioner3. Grant for free access to public hospital4. Specified purpose grant to state and territory

governments and other bodies

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:

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

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 volumeThen the PBPA(pharmaceutical benefits pricing authority ) undertakes negotiations with the supplier and this is sent to the minister of health and ageing for approval.

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

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

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

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

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

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

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

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

• The authority : applications areMade 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

• 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

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

• 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

Product liability

• Legal provisions : Australia's product liability laws are a mixture of common law and various federal , state and territory statutes.

References

• www.tga.gov.au• www.parmida.ca• www.ipaustralia.gov.au

• Noushun Javidvand sep. 2013