Changes to clone and Extension of Indications (no data) application

Consistent with the Government's deregulation agenda, the TGA has rationalised the processes for applications for additional trade names and extension of indications and has streamlined the application pathways by developing new forms and guidance materials.

Additional trade names applications

From 1 July 2015, applications to register (an) additional trade name(s) to an existing prescription medicine by the same sponsor on the Australian Register of Therapeutic Goods (ARTG) will be evaluated under section 16G of the Therapeutic Goods Regulations 1990 (the Regulations) which applies a statutory limit of 45 working days to make a decision on the application or raise an objection concerning the application.

A form and guidance material will be available on the 1st July 2015 to help sponsors complete their applications.

Extension of indications (no data) applications

From 1 July 2015, applications to extend the indications for a registered medicine where the indications have already been approved for the reference medicine will also be evaluated under section 16G of the Regulations which applies a statutory limit of 45 working days to make a decision on the application or raise an objection concerning the application, where the application does not need to be supported with clinical, pre-clinical and/or bioequivalence data.

A new fee will be applicable for this type of application. Information on TGA fees and charges will be published on the website on 1 July 2015.

A form and guidance material will be available on the 1 of July 2015 to help sponsors complete their applications.

Extension of indications applications that require clinical, pre-clinical and/or bioequivalence data for a registered medicine will continue to be regulated as a Category 1 application under the Prescription medicines registration process and the 255 working day statutory evaluation time period will still apply.

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