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regulatory guidance

29 March 2021
Guidance for sponsors and manufacturers wanting to submit data in the NeeS format
29 March 2021
Guidance for sponsors and manufacturers wanting to submit data in the electronic Common Technical Document (eCTD) format
6 July 2020
Guidance to assist sponsors when using the code tables for GMP Clearance applications
16 September 2020

Provides guidance for sponsors on the regulatory requirements for medicine presentation for listed medicines:

  • Listed medicine presentation
  • Unacceptable presentation of a listed medicine
  • Listed medicine labels
  • TGA assessment of medicine labels
  • Listed medicine label names
  • Labelling requirements for specific ingredients/listed medicines
24 July 2019

Useful information for preparing your application can be found in the TBS portal under 'Public TGA information'. These include:

  • Code Tables
  • Ingredients
  • Ingredients – Proprietary
  • Indications for Listed Medicines
  • ...
8 April 2021
...
Version history
Version Description of change Author Effective date
V1.0 Original publication
8 April 2021

The glossary for this guidance is included in the TGA glossary.

8 April 2021

The TGA aims to harmonise where appropriate with relevant international guidance. Many international jurisdictions will have regulatory guidance and information that is in line with global best practice concerning cyber security quality management and risk management systems, and therefore...

8 April 2021

The rapid change of pace of the cyber security threat landscape relative to the development and implementation of standards means that manufacturers, sponsors and in some circumstances, users of medical devices, must continually assess and understand emerging global cyber security standards and...

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