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Prescription medicines regulatory decisions and notices (archived)

2016 2015 2014 2013 2010


  • Australian eCTD submissions
    13 January 2016: An interface between applicants (or manufacturers) and the TGA, the Australian eCTD format facilitates the validation, reviewing and electronic processing of applications
  • Brochure: Pre-submission phase: Type A and D applications
    29 June 2016: The pre-submission pilot will test the effectiveness of removing the need to provide a 'Module 2 or equivalent' with your Pre-submission Planning Form (PPF)