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. 

Reviewed October 2011

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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 Evaluation

HealthInsite Topic Page
Links to information about the evaluation of drugs for use in Australia.

Drug Monitoring

HealthInsite Topic Page
Links to information on the post market monitoring of the safety of prescription drugs.

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.

Exporting Drugs

HealthInsite Topic Page
Links to information about exporting drugs from Australia.

Regulation of Complementary Therapies and Medicines

HealthInsite Topic Page
Links to information about the regulation and approval of the complementary and alternative therapies and medicines industry.

30 Resources Found

Results 1 to 20 displayed.     1  2 

Title:   Australian Public Assessment Reports for prescription medicines (AusPARs)
Publisher:   Australian Government Department of Health and Ageing
Description:   An AusPAR provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve an application
Date:   Jan 2012
Title:   European Union guidelines replaced or superseded
Publisher:   Australian Government Department of Health and Ageing
Description:   List of European Union guidelines replaced or superseded (previously published as adopted in Australia)
Date:   Oct 2011
Title:   Advisory Committee on Non-prescription Medicines (ACNM)
Publisher:   Australian Government Department of Health and Ageing
Description:   The Advisory Committee on Non-prescription Medicines (ACNM) advises and makes recommendations to the TGA regarding the entry of non-prescription medicines on the Australian Register of Therapeutic Goods.
Date:   Dec 2011
Title:   Advisory Committee on Prescription Medicines (ACPM)
Publisher:   Australian Government Department of Health and Ageing
Description:   The Advisory Committee on Prescription Medicines (ACPM) advises and makes recommendations to the TGA regarding the entry of prescription medicines on the Australian Register of Therapeutic Goods.
Date:   Jan 2012
Title:   Prescription medicine BPR update newsletter
Publisher:   Australian Government Department of Health and Ageing
Description:   Reports on progress in the prescription medicines business process review (BPR) program
Date:   Aug 2011
Title:   Questions & answers about the streamlined submission process
Publisher:   Australian Government Department of Health and Ageing
Description:   Questions and answers about the streamlined submission process for prescription medicines in Australia
Date:   Jan 2012
Title:   Orphan drugs
Publisher:   Australian Government Department of Health and Ageing
Description:   An orphan drug is defined as a medicine, vaccine or in vivo diagnostic agent that is: intended to treat, prevent or diagnose a rare disease; or not commercially viable to supply to treat, prevent or diagnose another disease or condition
Date:   Jan 2012
Title:   Evaluation of a new medicine - The TGA's lifecycle approach to regulation
Publisher:   Australian Government Department of Health and Ageing
Description:   The TGA aims to ensure that the community has access to therapeutic advances within a reasonable timeframe
Date:   Jun 2011
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
Date:   Nov 2011
Title:   Guidance on the GMP clearance of overseas medicine manufacturers
Publisher:   Australian Government Department of Health and Ageing
Description:   Provides information to sponsors and manufacturers on the acceptable form of evidence of GMP compliance for overseas manufacturers and outlines how to submit such evidence to the TGA for assessment
Date:   May 2011
Title:   Streamlined submission process for prescription medicines
Publisher:   Australian Government Department of Health and Ageing
Description:   The streamlined submission process for the registration of new prescription medicines and major variations to existing medicines, will provide clarity of TGA requirements and predictability in timeframes
Date:   May 2011
Title:   Medicines & medical devices
Publisher:   Australian Government Department of Health and Ageing
Description:   General information for consumers about medicines and medical devices in Australia
Date:   Mar 2011
Title:   How therapeutic goods are regulated in Australia
Publisher:   Australian Government Department of Health and Ageing
Description:   The regulation of therapeutic goods in Australia is designed to ensure the quality, safety, efficacy and performance of medicines and medical devices.
Date:   Feb 2011
Title:   AusPARs: Questions & answers
Publisher:   Australian Government Department of Health and Ageing
Description:   AusPAR is designed to summarise the steps in the evaluation process that led the TGA to approve or not approve a prescription medicine submission
Date:   Aug 2010
Title:   PharmBiz objectives and the PharmCIS IT program
Publisher:   Australian Government Department of Health and Ageing
Description:   Information on the objectives of PharmBiz and implementation of the PharmCIS IT program.
Date:   Aug 2010
Title:   IV Thiamine (access to)
Publisher:   Australian Government Department of Health and Ageing
Description:   The TGA is notifying clinicians that is no longer possible to extend the previous exemption for Baxter Healthcare to supply IV Thiamine in Australia.
Date:   Jul 2010
Title:   Codeine rescheduling - information for sponsors
Publisher:   Australian Government Department of Health and Ageing
Description:   NDPSC resolutions in June and October 2009 have the effect of removing all OTC combination analgesics containing codeine (CACC) (other than phenylephrine-containing combinations for the treatment of coughs and colds) from Schedule 2 of the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP), from 1 May 2010
Date:   Feb 2010
Title:   Reductil (sibutramine) product information
Publisher:   Australian Government Department of Health and Ageing
Description:   Advice from the Therapeutic Goods Administration about Reductil (sibutramine) product information, details safety issues regarding increased risk of heart attack and stroke.
Date:   Jan 2010
Title:   TGA approves Pandemic (H1N1) 2009 influenza vaccine for use in children aged from 6 months of age
Publisher:   Australian Government Department of Health and Ageing
Description:   Australia's medicines regulator, the TGA, has today approved the use of Panvax H1N1 influenza vaccine to include children aged from 6 months of age.
Date:   Dec 2009
Title:   TGA approves vaccine against Pandemic (H1N1) 2009 influenza
Publisher:   Australian Government Department of Health and Ageing
Description:   Australia's medicines regulator, the 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

Results 1 to 20 displayed.     1  2