Australian Regulators Launch Electronic Submission System for Pharmaceuticals

Posted 26 February 2014 By Alexander Gaffney, RAC

Australian regulators with its Therapeutic Goods Administration (TGA) have announced that they will soon adopt an electronic system capable of receiving drug applications without the use of paper.

Background

TGA first announced its intent to move forward with the transition in October 2013. At present, TGA receives all of its submissions in paper format, which is expensive for industry to create and regulators to store. New drug applications can be tens, and often hundreds of thousands of pages in total length.

As global regulators, including the US Food and Drug Administration (FDA), often attest, digital copies of applications are cheaper to generate and store, but also allow for faster, easier and better analysis of applications.

At the core of most electronic drug submissions systems is the electronic common technical document (eCTD), a digital module-based regulatory application form developed and maintained by the International Conference on Harmonisation (ICH). The basic premise of the eCTD is to harmonize the layout and format of pharmaceutical submission documents to the extent possible to allow for easier and faster filing and reviews of applications.

The eCTD is already used by FDA, the European Medicines Agency (EMA) and Japan's Ministry of Health, Labour and Welfare (MHLW). In the US, use of the electronic standard is set to soon become mandatory.

Australia's Shift

But for whatever reason, Australia has been slow to fully adopt the electronic standard.

Current applications to TGA are submitted in both paper and electronic format, which TGA acknowledged is costly and difficult to process. Though the electronic forms allow for somewhat easier processing, the hard copy submitted to TGA is deemed to be the, "Authoritative source of data supporting a regulatory application."

At the time, TGA said it was planning to work closely with the pharmaceutical industry to establish an eCTD framework and to develop an implementation timetable.

Now that system is coming online. In a 26 February 2014 announcement, TGA said it has adopted Lorenz' docuBridge software platform to receive, review and process electronic applications for prescription medicines regulated under its Register of Therapeutic Goods (ARTG).

"The TGA looks forward to working with stakeholders throughout 2014 to introduce this system that will improve the quality and reduce the cost of medicines applications to the TGA," it said, adding that it will work with industry throughout the coming year to ensure a smooth transition.

The new system will not require companies to submit paper documentation at all, it explained.

 

TGA Statement

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Categories: TGA

Tags: Electronic Common Technical Document, eCTD, australia

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