Policies and strategies
The National Medicines Policy
The National Medicines Policy brings together:
- the Australian Government
- state and territory governments
- the health and medicines industry
- the media.
It aims to provide Australians with equal and affordable access to medicines, through:
- timely access to affordable medicines for Australians
- medicines that meet quality, safety and efficacy standards
- quality use of medicines
- a responsible and viable medicines industry.
The National Quality Use of Medicines Strategy
Quality use of medicines is one of the central objectives of the National Medicines Policy. It is about:
- ensuring medicines are used only when needed
- choosing suitable medicines
- using medicines safely.
The National Strategy for Quality Use of Medicines Strategy sets out the approach we are taking to achieve quality use of medicines in Australia.
The strategy recognises that many people do not need medicines to be healthy, while for others, medicines play an important role in maintaining health, preventing illness and curing disease.
Read the strategy’s executive summary.
The Australian Medicines Handbook is an essential reference tool for medical practitioners, pharmacists, nurses, nurse practitioners, dentists, students, hospitals, aged care facilities and any health practitioners with an interest in the quality use of medicines.
National Medicines Policy resources collection
Increasing the use of biosimilar medicines
Biosimilar medicines are encouraging competition in the Australian market. They are as effective as the original, or ‘reference’, brand of biological medicine. We encourage health professionals to prescribe biosimilar brands because they:
- improve access to treatments for seriously ill patients
- help make the Pharmaceutical Benefits Scheme (PBS) more sustainable through increased competition between brands
- result in savings to the healthcare system.
Greater use of biosimilars supports the objectives of the National Medicines Policy.
We help to ensure the safety and quality of medicines through regulation of all medicines supplied in Australia.
What we regulate
We regulate how medicines are:
- manufactured – all Australian manufacturers must be licensed by the Therapeutic Goods Administration (TGA), and all overseas manufacturers must be certified by the TGA or another medicine regulator that applies the same requirements and standards as the TGA
- made available for supply – all medicines must go through the relevant approval process
- advertised – there are strict requirements to protect vulnerable patients
- prescribed – only approved health practitioners can prescribe prescription-only medicines
- supplied – some can only be dispensed by a pharmacist, while others are available over the counter
- imported – the Personal Importation Scheme allows you to import a 3-month supply of medicine in some cases, but take care to do this safely
- exported – it is only legal to take PBS-subsidised medicines out of Australia if it is for personal use.
How we regulate
We regulate medicines – from vitamins to prescription and controlled medicines – through the TGA, under the Therapeutic Goods Act 1989 and Therapeutic Goods Regulations. We:
- assess medicines for safety, quality and efficacy
- publish information about approved products in the Australian Register of Therapeutic Goods (ARTG)
- conduct a health technology assessment before subsidising medicines through the PBS
- undertake monitoring and surveillance of medicines to make sure they continue to meet safety and quality standards and do what they claim
- monitor prescriptions of controlled substances, so that Australians can benefit from their therapeutic uses, while minimising the risk of addiction and misuse
- investigate reports of counterfeiting, tampering and illegal supply
- take action if there is an issue with a medicine, including recalls
- license Australian manufacturers and ensure overseas manufacturers comply with Australia’s standards
- regulate the import, export and manufacture of controlled substances, through the Office of Drug Control.
To minimise any risk to patients, we – and the state and territory governments – ensure that only authorised health practitioners can prescribe medicines. The National Health Act 1953 and National Health (Pharmaceutical Benefits) Regulations specify who is authorised to prescribe different types of medicines under the PBS.
State and territory governments each have their own laws regulating who can prescribe medicines according to each medicine’s schedule classification.
Medicine access and supply
We work to improve the affordability of prescription medicines for Australians, including through the:
- Repatriation PBS (RPBS)
- Life Saving Drugs Program (LSDP).
We have measures in place to:
- consult with the public about medicines applying to be listed on the PBS
- support people who need medicines not listed on the PBS, RPBS or LSDP
- provide alternative ways for patients to access medicines during shortages
- manage supply of medicines during emergencies.
We provide support to ensure the safe management of medicines for:
Medicine safety monitoring and reporting
If you think you might be having a side effect to a medicine, speak to your doctor or pharmacist.
The TGA monitors the ongoing safety of all medicines. You can report suspected side effects to the TGA, which uses these reports to identify new safety information about medicines.
If the TGA finds a new safety issue for a medicine, it might:
- require changes to product labelling, such as adding a warning
- limit the types of patients who can take the medicine
- require the pharmaceutical company to do more research
- require the company to recall the medicine
- take the medicine off the market and ARTG.
You can also report other types of medicine problems to the TGA, such as:
- suspected fake or counterfeit medicines
- issues with packaging, labelling or storage.
Initiatives and programs
We support various initiatives and programs to improve access to medicines and their safety, quality and effectiveness.
We work with the Pharmacy Guild of Australia, the Pharmaceutical Society of Australia and other stakeholders on supporting access to PBS-subsidised medicines and related services through community pharmacies.
We do this under the Seventh Community Pharmacy Agreement, which aims to ensure Australians can access safe, affordable and life-saving medicines when they need them.
The Australian Healthcare Associates administer the pharmacy programs funded under the Seventh Community Pharmacy Agreement under the banner of Pharmacy Programs Administrator.
Pharmacy programs to support patients include:
- Home Medicines Review
- Residential Medication Management Review and Quality Use of Medicines Program
- MedsCheck and Diabetes MedsCheck
- Dose Administration Aids Program
- Indigenous Dose Administration Aids Program
- Staged Supply Services Program.
See data about the use of the pharmacy programs.
See data about the Rural Support and Aboriginal and Torres Strait Islander Pharmacy Programs.
Committees and groups
Several committees and groups provide advice and recommendations on various issues related to medicines.
- The Australian Technical Advisory Group on Immunisation provides advice on the National Immunisation Program and other immunisation issues.
- The Australian Advisory Council on the Medicinal Use of Cannabis provides advice on issues relating to the medicinal use of cannabis.
- The COVID-19 Vaccines and Treatments for Australia – Science and Industry Technical Advisory Group provides advice on the purchasing and manufacturing of COVID-19 vaccines and treatments.
- The Life Saving Drugs Program Expert Panel considers all applications to list new medicines on the program.
- The Pharmaceutical Benefits Advisory Committee assesses and recommends new medicines for listing on the PBS
- The TGA’s statutory advisory committees provide independent expert advice on specific scientific and technical matters, including for medicines, biological medicines, complementary medicines, vaccines and scheduling.
We regulate clinical trials to test whether new medicines are safe and effective.
We also support medical research and innovation through various grant programs, including those of the:
- Medical Research Future Fund, which provides funding opportunities for researchers every year
- National Health and Medical Research Council
- Australian Research Council
- various Department of Industry programs.