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Submitting data in the eCTD format - Therapeutic Goods Administration - Australia

Updated: Aug 21, 2021



This information is for sponsors and manufacturers wanting to submit data in the electronic Common Technical Document (eCTD) format for a:

  • prescription medicine

  • biological

  • over-the-counter medicine

  • registered complementary medicine

  • assessed listed medicine

  • listed medicine ingredient

  • master file.

This guidance is:

  • a step-by-step guide on submitting an eCTD sequence to the TGA.

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The views expressed in this publication do not necessarily reflect the views of any guidance of government, health authority, it's purely my understanding. This Blog/Web Site is made available by a regulatory professional, is for educational purposes only as well as to give you general information and a general understanding of the pharmaceutical regulations, and not to provide specific regulatory advice. By using this blog site you understand that there is no client relationship between you and the Blog/Web Site publisher. The Blog/Web Site should not be used as a substitute for competent pharma regulatory advice and you should discuss from an authenticated regulatory professional in your state.  We have made every reasonable effort to present accurate information on our website; however, we are not responsible for any of the results you experience while visiting our website and request to use official websites.

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