Medicines regulation and the TGA
Purpose of this document
This document provides a general introduction to the regulatory process for medicines in Australia. (Therapeutic devices <http://www.tga.gov.au/devices/devices.htm> are dealt with in other publications). It is designed to help you determine whether your product is likely to be regulated by the TGA.
For more detailed information refer to the following:
- Australian regulatory guidelines for complementary medicines
<http://www.tga.gov.au/docs/html/argcm.htm> - Australian regulatory guidelines for OTC medicines
<http://www.tga.gov.au/docs/html/argom.htm> - Australian regulatory guidelines for prescription medicines
<http://www.tga.gov.au/pmeds/argpm.htm>
Introduction
The Australian community has an expectation that therapeutic goods are safe and of high quality, to a standard equal to that of comparable countries. The objective of the Therapeutic Goods Act 1989 ('the Act') is to provide a national framework for the regulation of therapeutic goods in Australia, so as to ensure their
- quality
- safety
- efficacy, where appropriate, and
- timely availability.
The Therapeutic Goods Administration (TGA), as part of the Australian Government Department of Health and Ageing, has responsibility for administering the Act. Essentially, any product for which therapeutic claims are made must be either listed or registered in the Australian Register of Therapeutic Goods (ARTG) before it can be supplied in Australia.
A key focus of the TGA is to ensure that consumers have timely access to medicines. This includes ensuring that the necessary evaluation and assessment procedures are conducted to enable consumers access to the latest treatments available which are safe and of good quality.
The regulatory framework within which the TGA operates is based on a risk management approach. It is designed to ensure public health and safety, while at the same time freeing industry from any unnecessary regulatory burden and minimising the cost of medicines regulation.
In undertaking its responsibilities, the TGA has developed a constructive partnership with industry. The result is a regulatory system that allows the public access to safe therapies while contributing to the continued viability of industry by creating confidence in, and acceptance of, Australian therapeutic goods, both at home and overseas.
Role of the TGA
The TGA carries out a range of assessment and monitoring activities to ensure that all therapeutic goods available in Australia are of an acceptable standard. At the same time, the TGA aims to ensure that the Australian community has access, within a reasonable time, to therapeutic advances.
Overall control of medicines is exerted through five main processes:
- pre-market evaluation and approval of registered products intended for supply in Australia;
- development, maintenance and monitoring of the systems for listing of medicines;
- licensing of manufacturers in accordance with international standards of Good Manufacturing Practice;
- post-market monitoring, through sampling, adverse event reporting, surveillance activities, and response to public inquiries; and
- the assessment of medicines for export.
Fees and charges
From 1 July 1998, the TGA has been required by the Government to fully recover its operating costs for all activities that fall within the scope of the Act, including regulation of industry and the TGA's public health responsibilities.
Changes to the level of fees and charges are negotiated with industry representatives of the TGA Industry Consultative Committee.
A list of fees is included in Schedule 9 of the Therapeutic Goods Regulations 1990 (the Regulations). A list of charges can be found in the Therapeutic Goods (Charges) Regulations.
A comprehensive Schedule of Fees and Charges is available from this website <http://www.tga.gov.au/docs/html/feesach.htm>. Please note that these fees and charges change from time to time.
Therapeutic Goods Act 1989
The Act <http://www.tga.gov.au/legis/index.htm#acts> sets out the legal requirements for the import, export, manufacture and supply of medicines in Australia. It details the requirements for listing or registering all medicines on the Australian Register of Therapeutic Goods (ARTG), as well as many other aspects of the law including advertising, labelling, and product appearance. The Act is supported by the Regulations, and various Orders and Determinations which provide further details of matters covered in the Act. The Act is a Commonwealth Act that provides a substantially uniform national system of controls over therapeutic goods, facilitating trade between the States/Territories and benefiting both consumers and industry.
Current updates
The Act, Regulations, Orders and Determinations are amended from time to time. It is important to know the current regulatory requirements. Changes are announced in the TGA News <http://www.tga.gov.au/docs/html/tganews/tganews.htm>, in the fortnightly email sent out to subscribers <http://www.tga.gov.au/new/tga-update-subscribe.asp> or on the TGA website. If you wish to be added to the TGA News circulation list please contact the TGA Communications Unit on 1800 020 653.
Copies of the legislation can be obtained from the Attorney General's Department <http://www.comlaw.gov.au>.
Other legislation
Other Commonwealth, State, and Territory legislation may apply to certain medicines. The scheduling of substances in the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) and the safe storage of therapeutic goods (eg. by wholesalers) are also covered by State or Territory legislation. For further details on relevant State or Territory legislation contact the Health Department in your State or Territory.
Role of the sponsor
Under the Act, a 'Sponsor' is someone who:
- imports therapeutic goods;
- manufactures therapeutic goods;
- has therapeutic goods imported or manufactured on their behalf, or
- exports therapeutic goods from Australia.
The sponsor of a medicine is the person or company responsible for applying to the TGA to have their medicine included in the ARTG.
Australian Register of Therapeutic Goods (ARTG)
The ARTG <http://www.tga.gov.au/docs/html/artg.htm> is established under Part 3 of the Act. It includes a computer database of information about therapeutic goods for human use which are approved for supply in, or export from, Australia.
All medicines manufactured for supply in Australia must be listed or registered in the ARTG, unless they are specifically exempt or excluded.
Assessment criteria
Whether a product is listed or registered in the ARTG depends largely on three things:
- the ingredients;
- the dosage form of the product; and,
- the promotional or therapeutic claims made for the product.
In assessing the level of 'risk', factors such as the strength of a product, side effects, potential harm through prolonged use, toxicity, and the seriousness of the medical condition for which the product is intended to be used are taken into account.
Does the Act apply to your product?
You will need to comply with the Act if your product is a 'therapeutic good'. 'Therapeutic goods' may be:
- medicines, or
- medical devices
Some products will be classified as a medicine (and therefore covered by the Act) or as a food or cosmetic (and therefore not covered by the Act) depending on how that particular product fits with the criteria set out in the Act.
What are 'therapeutic goods'?
A 'therapeutic good' is broadly defined as a good which is represented in any way to be, or is likely to be taken to be, for therapeutic use, unless specifically excluded or included under section 7 of the Act.
For the purposes of evaluation and assessment, a therapeutic good is a product for use in humans that is used in, or in connection with:
- preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury; or
- influencing inhibiting or modifying a physiological process; or
- testing the susceptibility of persons to a disease or ailment; or
- influencing, controlling or preventing conception; or
- testing for pregnancy; or
- the replacement or modification of parts of the anatomy.
Is it a medicine or food?
Products for oral consumption are regulated as either foods or therapeutic goods. Use is made of the definition above from section 3 of the Act to determine whether a product is a food or a medicine.
If there is no prescribed standard in the Food Standards Code, and there is no tradition of use as a food in the form presented, the goods are most likely not a food.
Products which may fit within the definition of either a food or a medicine are referred to a joint TGA/Food Standards Australia New Zealand (FSANZ) committee ERPIM (External Reference Panel on Interface Matters) which recommends whether the goods should be regulated as a therapeutic good or as food.
The presentation of a product can help to determine whether it will be treated as a food or a medicine. For example, a clove of garlic is a food. However, if it is concentrated and marketed in capsule form with claims that it can be used to relieve cold and 'flu symptoms it will be treated as a medicine.
A product's principal use is of primary consideration when determining whether it is a food or a medicine.
Is it a medicine or a cosmetic?
One of the main factors in determining whether a product is a cosmetic or a medicine is the claims made about the product. For example, moisturisers which contain a sunscreening agent as a secondary component and have a stated therapeutic purpose (e.g. 'helps protect skin from the damaging effects of UV radiation') are medicines.
Even if a product is intended for marketing as a cosmetic, it may be classified as a medicine, depending on its ingredients, route of administration, or if therapeutic claims are made on its label, or in advertising.
Note that the Trade Practices Act 1974 also operates in this area and influences what may or may not be claimed. The publication Cosmetic Claims Guidelines <http://www.tga.gov.au/docs/html/cosclaim.htm> issued by the National Coordinating Committee on Therapeutic Goods (available from the TGA website), provides further guidance on the difference between cosmetic and therapeutic claims.
Risk management approach
The TGA uses a 'risk-management' approach to regulating medicines supplied in Australia. This refers to the level of scrutiny applied to individual applications for inclusion in the ARTG.
Medicines used to treat serious conditions, or which need to be used under a doctor's supervision, are subjected to a high level of scrutiny and evaluation to determine their quality, safety and efficacy.
Other products, for example many complementary medicines (such as herbal, vitamin and mineral products), are not generally subject to the same level of evaluation and are assessed only for quality and safety.
How is 'risk' assessed?
A product's 'risk' is determined by a number of factors, including whether:
- the medicine contains a substance scheduled in the SUSDP;
- the medicine's use can result in significant side effects;
- the medicine is used to treat life-threatening or very serious illnesses;
- there may be any adverse effects from prolonged use or inappropriate self-medication.
Risk is not an absolute concept. It is an assessment of the potential of a product to do harm to those it is intended to help, or to others (such as children) who may come in contact with it regardless of whether the harm results from following or disregarding the directions for use.
Special access to unapproved medicines
In certain circumstances, individuals may be granted access to medicines that have not yet been approved for entry into the ARTG. For further details, contact the TGA.
Listed medicines
Listed medicines are considered to be of lower risk than registered medicines, so the Regulations allow sponsors to 'self assess' their products in some situations. The majority of listed medicines are self-selected by consumers and used for self-treatment.
Listed medicines may only contain well known established ingredients, usually with a long history of use, such as vitamin and mineral products or sunscreens. They do NOT contain substances that are scheduled in the SUSDP.
Listed medicines are assessed by the TGA for quality and safety but not efficacy. This means that the TGA has not evaluated them individually to see if they work.
It is a requirement under the Act that sponsors hold information to substantiate all of their product's claims. Guidelines for levels and kinds of evidence to support indications and claims are available <http://www.tga.gov.au/docs/html/tgaccevi.htm>.
Most complementary medicines (eg. herbal, vitamin and mineral products) and sunscreens are examples of listed products.
Medicines which are for export only are listed (not registered) on the ARTG.
All listed medicines must display an "AUST L" number on the label as proof of listing.
Registered medicines
Medicines assessed as having a higher level of risk must be registered (not listed). The degree of assessment and regulation they undergo is rigorous and detailed, with sponsors being required to provide comprehensive safety, quality and efficacy data.
All registered medicines:
- must display an AUST R number on the label as proof of registration;
- are evaluated as either 'high risk' or 'low risk' registered.
Non-prescription (low risk) registered
- follow the route of evaluation described in Part 2 (non complementary), or Part 3 (complementary) of Schedule 10 of the Therapeutic Goods Regulations;
- do not include ingredients described in Schedule 4, Schedule 8, or Schedule 9 of the SUSDP;
- usually contain ingredients which are described in Schedule 2, Schedule 3, or sometimes Schedules 5 or 6 of the SUSDP;
- are available without prescription.
Examples: Mild analgesics, cough/cold preparations, anti-fungal creams.
Prescription (high risk) registered
- follow the route of evaluation described in Part 1 (mainly prescription) of Schedule 10 of the Therapeutic Goods Regulations;
- may include ingredients described in Schedule 4, Schedule 8 or Schedule 9 of the SUSDP;
- are usually only available on prescription.
Examples: all prescription medicines; all injectables (e.g. insulin for diabetics).
Complementary medicines
Complementary medicines (also known as 'traditional' or 'alternative' medicines) include vitamin, mineral, herbal, aromatherapy, and homoeopathic products.
See Schedule 14 of the Regulations for a list of the type of substances or products covered by the term 'complementary'.
Complementary medicines may be either listed or registered, depending on their ingredients and the claims made.
Most complementary medicines are listed in the ARTG and some are registered.
Exempt or excluded medicines
All medicines manufactured for supply in Australia must be listed or registered in the Australian Register of Therapeutic Goods (ARTG) unless they are exempt or excluded.
Excluded
Some products (mostly therapeutic devices, rather than medicines) may be unintentionally covered by the definition of a Therapeutic Good. They are therefore specifically excluded under section 7 of the Act.
None of the requirements of the Act apply to excluded products.
An example of an excluded good is unmedicated soap.
Exempt
Some medicines do not need to be registered or listed in the ARTG as a result of a specific exemption or determination. However, it is important to note that all other applicable requirements under the Act and Regulations (eg. standards and advertising or labelling) must be complied with.
Exemption from ARTG listing
- some goods are exempt from the need to be included in the ARTG;
- see section 18 of the Act and Schedules 5 and 5A of the Regulations.
Exemption from manufacturing requirements
- some medicines or persons are exempt from the manufacturing requirements set out in Part 4 of the Act.
- see section 34 of the Act, together with:
- Schedule 7 of the Regulations (exempt medicines);
- Schedule 8 of the Regulations (exempt persons).
Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP)
The SUSDP is the document through which a uniform national approach to medicine availability, labelling and packaging is achieved. Most medicines contain substances listed in the SUSDP (or covered by its provisions), and are grouped into 'Schedules' according to the appropriate level of control required over access and availability to protect public health and safety. This classification process takes into account a substance's toxicity profile, pattern of use, indications, product formulation and dosage, potential for abuse and need for access.
The categories of the SUSDP which are most relevant to medicines on the ARTG are:
- Schedule 4 (S4) - prescription only medicines;
- Schedule 3 (S3) - non-prescription medicines for supply by pharmacists only;
- Schedule 2 (S2) - non-prescription medicines the safe use of which may require advice from a pharmacist.
Some medicines are also included in Schedules 5 and 6 of the SUSDP, for example head lice preparations and some essential oils. Schedules 5 and 6 list substances with a low to moderate potential for causing harm, the extent of which can be reduced through the use of appropriate labelling and packaging.
The SUSDP affects the supply, labelling, packaging and availability of medicines and is given legal effect by State and Territory legislation. Medicines which are not scheduled in the SUSDP can be sold through any distribution outlet, such as a supermarket or health food store. However, some unscheduled or exempt medicines may be covered by labelling or packaging requirements specified in the SUSDP (eg. some paracetamol and iron preparations). Examples of medicines which are unscheduled include small packs of simple pain relievers, and most vitamins and minerals. The SUSDP is available from National Mailing and Marketing Pty Ltd <http://www.tga.gov.au/ndpsc/susdp.htm> ((02) 6269 1035).
Manufacturing requirements
Australian manufacturers of therapeutic goods must be licensed under Part 4 of the Act. Their manufacturing processes must comply with the principles of GMP (Good Manufacturing Practice).
The aim of these licensing requirements and standards is to protect public health by ensuring that medicines meet defined standards of quality and are manufactured in conditions that are clean and free of contaminants.
GMP requirements apply irrespective of whether a good is listed, registered or exempt (see above).
For further information see: Manufacturing <http://www.tga.gov.au/manuf/index.htm>.
Advertising and labelling
The Act and its associated Regulations govern the appearance and content of labels and advertising, for which there is a specific Therapeutic Goods Advertising Code (available from the ComLaw Internet site <http://www.comlaw.gov.au>).
Assistance in preparing applications
Professional agents are available to assist in the preparation of applications for listing or registering medicines in the ARTG. These can be found through the relevant industry association or under "Chemists - Consulting &/or Industrial" in the Yellow Pages.
TGA contacts
Phone: 1800 020 653
Fax: 02 6232 8605
Email: info@tga.gov.au
TGA website: <www.tga.gov.au>
© Commonwealth of Australia 2004