Australia’s TGA Upgrades its OTC Online Application System

An upgrade to Australia’s Therapeutic Goods Administration’s (TGA) online application system for OTC drugs will make it easier for sponsors to submit applications and for the TGA to process them, the agency said Friday.

The system will go offline just before midnight on April 6, though all submitted applications will be retained and processing on those applications will continue, TGA promises.

The upgraded system, which will go into effect at 6 am on April 9, will still be found on the eBusiness Services section of the TGA website and is part of a staged implementation of the harmonization of regulatory frameworks between Australia and New Zealand, known as the Australia-New Zealand Therapeutic Products Authority, slated for completion by July 2016.

New features of the OTC application system include built-in validation rules that prompt the input of required information, the ability to submit supplemental documents as attachments with clear prompts for each application category and clear presentation to the applicant of application status from submission to finalization, TGA says.

Australia last month announced that it was adopting Microsoft-based software that would align with the electronic common technical document format, allowing drugmakers to submit applications for marketing authorization online, potentially saving money and garnering faster reviews. — Lena Freund

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