Drug Approvals and Licensing

Follow the links below to find information on the approval and licensing of drugs and medicines.

Follow the links to the specific topic pages below to find information about the approval of new products, codes of practice and quality control.

The Australian Prescriber provides information on drugs recently marketed in Australia, appropriate use of diagnostic tests and interpretation of laboratory results.

The TGA - Therapeutic Goods Administration [Australian Government Department of Health and Ageing] is the Australian Government body that is responsible for carrying out a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an acceptable standard. 

Updatd May 2009

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Related HealthInsite Topics
Drugs and Devices Registration Services
HealthInsite Topic Page
Links to services related to approval and evaluation of therapeutic drugs and devices, including registration processes.
Drug Standards and Best Practice
HealthInsite Topic Page
Links to information on medicines and drug manufacturing standards and best practice, including codes of conduct and international standards.
Drug Evaluation
HealthInsite Topic Page
Links to information about the evaluation of drugs for use in Australia.
Exporting Drugs
HealthInsite Topic Page
Links to information about exporting drugs from Australia.
Regulation of Complementary Therapies and Medicines
HealthInsite Topic Page
Links to resources about the regulation and approval of the complementary and alternative therapies and medicines industry.
Drug Monitoring
HealthInsite Topic Page
Links to information on the post market monitoring of the safety of prescription drugs.
44 Resources Found
Results 1 to 20 displayed.
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Title:   TGA approves vaccine against Pandemic (H1N1) 2009 influenza
Publisher:   Australian Government Department of Health and Ageing
Description:   Australia's medicines regulator, the Therapeutic Goods Administration (TGA), has today approved the registration of Panvax H1N1 influenza vaccine, for use in adults and children 10 years of age and over.
Date:   Sep 2009
Title:   Media release. TGA green lights pandemic flu vaccine
Publisher:   Australian Government Department of Health and Ageing
Description:   Australia's independent medicines' regulator, the Therapeutic Goods Administration (TGA), today announced it will register the CSL pandemic influenza (swine flu) vaccine. This decision paves the way for a national vaccination program to start later this month.
Date:   Sep 2009
Title:   Draft compositional guidelines
Publisher:   Australian Government Department of Health and Ageing
Description:   Complementary Medicine Compositional Guidelines are intended to provide clarity to the specific form or type of substances that the Therapeutic Goods Administration (TGA) approves for use in listed medicines.
Date:   Jul 2009
Title:   European Union guidelines replaced or superseded (Previously published as adopted in Australia)
Publisher:   Australian Government Department of Health and Ageing
Description:   A list of European Union guidelines REPLACED or SUPERSEDED (Previously published as adopted in Australia)
Date:   Jul 2009
Title:   European Union guidelines published as adopted in Australia
Publisher:   Australian Government Department of Health and Ageing
Description:   A list of European Union guidelines published as adopted in Australia
Date:   Jun 2009
Title:   Cost recovery impact statement - Annual review of fees and charges 2009-10 - Prescription medicines
Publisher:   Australian Government Department of Health and Ageing
Description:   The Therapeutic Goods Administration (TGA) is proposing to increase prescription medicines fees and charges by 6.6 per cent for 2009-2010. The increases are planned to take effect from 1 July 2009.
Date:   Jun 2009
Title:   Cost recovery impact statement - Annual review of fees and charges 2009-10 - Non-prescription medicines
Publisher:   Australian Government Department of Health and Ageing
Description:   The Therapeutic Goods Administration (TGA) is proposing to increase non-prescription (registered) medicines fees and charges by 13.3 per cent for 2009-2010. The increases are planned to take effect from 1 July 2009.
Date:   Jun 2009
Title:   Cost recovery impact statement - Annual review of fees and charges 2009-10 - Complementary medicines
Publisher:   Australian Government Department of Health and Ageing
Description:   The Therapeutic Goods Administration (TGA) is proposing to increase complementary medicines fees and charges by 14.3 per cent for 2009-2010.
Date:   Jun 2009
Title:   Drugs designated as orphan drugs
Publisher:   Australian Government Department of Health and Ageing
Description:   A list of drugs that have been designated as 'orphan drugs' for the purposes of Regulation 16J of the Therapeutic Goods Regulations
Date:   Jun 2009
Title:   Medicines: Consumers
Publisher:   Australian Government Department of Health and Ageing
Description:   Links to information for consumers about medicines
Date:   Mar 2009
Title:   Regulation of complementary medicines
Publisher:   Australian Government Department of Health and Ageing
Description:   This page provides links to resources of relevance to complementary medicines.
Date:   Mar 2009
Title:   Australian regulatory guidelines for OTC medicines (ARGOM)
Publisher:   Australian Government Department of Health and Ageing
Description:   These Guidelines describe the information to be supplied with an application for registration of OTC (over-the-counter) medicines in the Australian Register of Therapeutic Goods (ARTG).
Date:   Dec 2008
Title:   Paediatric Medicines Advisory Group
Publisher:   Australian Government Department of Health and Ageing
Description:   This page of the website contains information on the Paediatric Medicines Advisory Group
Date:   Nov 2008
Title:   Regulatory reforms proposed for prescription medicines
Publisher:   Australian Government Department of Health and Ageing
Description:   The TGA has recently completed stakeholder consultations on a number of regulatory reforms proposed for each therapeutic product sector.
Date:   Sep 2008
Title:   Guidance on product changes in ELF3
Publisher:   Australian Government Department of Health and Ageing
Description:   Following the inclusion of a product as a Listed medicine in the Australian Register of Therapeutic Goods (ARTG), sponsors may wish to change certain details previously advised to the TGA. This guidance document has been developed to provide assistance to sponsors so that they are able to determine if a change to their ARTG entry for a particular product is necessary and the regulatory impact that making certain changes to currently Listed products may have.
Date:   Aug 2008
Title:   Annual review of fees and charges 2008-09 - Non-prescription (registered) medicines: Cost recovery impact statement
Publisher:   Australian Government Department of Health and Ageing
Description:   The TGA are proposing to increase non-prescription (registered) medicines fees and charges by 10 per cent for 2008-09.
Date:   May 2008
Title:   Guidance on the GMP clearance of overseas medicine manufacturers
Publisher:   Australian Government Department of Health and Ageing
Description:   This guidance document is intended to provide information on what is regarded by the TGA as an acceptable form of evidence, and guidance for sponsors and manufacturers on the submission of that evidence to the TGA for assessment. It is not intended to provide a definitive list of forms of evidence that are considered acceptable or unacceptable.
Date:   Mar 2008
Title:   PharmBiz
Publisher:   Australian Government Department of Health and Ageing
Description:   Information on the implementation of the review of Post Pharmaceutical Benefits Advisory Committee (pPBAC) Processes plus links to the report, communiques and contact details.
Date:   Feb 2008
Title:   Substances that may be used in listed medicines in Australia
Publisher:   Australian Government Department of Health and Ageing
Description:   The following substances are eligible for use in medicines Listed on the Australian Register of Therapeutic Goods for supply in Australia. The list includes the approved role of the substance (ie. active, excipient, and/or component), and any restrictions and conditions that apply to the substance when used in Listed medicines.
Date:   Dec 2007
Title:   The regulation of complementary medicines in Australia - An overview
Publisher:   Australian Government Department of Health and Ageing
Description:   In Australia, medicinal products containing herbs, vitamins, minerals, and nutritional supplements, homoeopathic medicines and certain aromatherapy products are referred to as 'complementary medicines'.
Date:   Apr 2007
Results 1 to 20 displayed.
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