THE Therapeutic Goods Administration (TGA) is proposing to go purely digital with its updated submissions platform and seeks stakeholder input.
As part of the TGA's electronic dossier reforms agenda, it is planning to provide an "updated electronic submissions platform that is appropriate for Australian sponsors and is cognisant of the best-practice initiatives that are operating in the international environment...providing a single, standardised dossier format forms part of this agenda."
This consultation paper summarises the model the TGA proposes to adopt as it transitions to accepting only eCTD formatted dossiers for prescription medicines.
The eCTD format was introduced within Australia in 2015, however it has been internationally utilised since 2003, following sign off by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), with the purpose of standardising dossier format globally and making the process more efficient for sponsors and regulators.
The consultation calls for input relating to suggested improvements, any perceived impacts on business, costs and benefits anticipated and suggestions around education and guidance material.
Visit tga.gov.au for more info.
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