What we're doing about medicines

We assess medicines for safety and quality and regulate how they are supplied. We work with state and territory governments and stakeholders to help ensure Australians have equal and affordable access to medicines when they need them.

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
  • consumers
  • 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.

Policy review

We are working with our partners to update the National Medicines Policy and associated guiding principles. The updated guiding principles will provide structures, processes and accountabilities for prescribers.

Read the discussion paper and terms of reference.

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

This collection contains the National Medicines Policy and other documents relevant to the policy.

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.

    Medicine regulation

    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:

    We have measures in place to:

    Managing medicines

    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.

    Pharmacy programs

    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:

    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.

    Medical research

    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:

    Contact

    Pharmaceutical Benefits Scheme (PBS) contact

    Contact us for information about medicines and the Pharmaceutical Benefits Scheme (PBS).

    PBS [at] health.gov.au

    View contact

    Last updated: 
    27 July 2022
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