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

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.