The TGA have released (17 January 2011) modifications to the streamlined submission process and recommend that sponsors check the application for each document carefully to ensure compliance with the appropriate version.

It will be necessary to use the modified submission process from 1 March 2011. Sponsors should also note the other TGA documents published elsewhere on the TGA website that may be applicable to their pre-submission planning forms and submissions. Such documents include:

• Australian Regulatory Guidelines for Prescription Medicines (ARGPM) http://www.tga.gov.au/pmeds/argpm.htm
• CTD Module 1 http://www.tga.gov.au/docs/html/eugctd.htm#mod1
• Guidance for industry on electronic prescription medicine submission dossiers http://www.tga.gov.au/pmeds/pmbpi-submissionnees.htm