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Back in 2012 a standard set of procedures, guidelines and agenda was established by Australia’s Therapeutic Goods Administration (TGA) in a bid to implement the submission of medicine applications using the electronic Common Technical Document (eCTD).
The stats
In 2011-12, the Australian Pharmaceutical industry clocked in exports of $4.06 billion. In the same year, the industry collected around $6.6 billion from Pharmaceutical Benefits Scheme (PBS) sales. A total of 41,000 people had been employed and the industry spent around $1billion on research and development in 2010-11. According to the Complementary Healthcare Council Annual Report (2011-12), sales of complementary medicines stood at $2 billion a year.
The Australian Register of Therapeutic Goods (ARTG) shows a total of 48,000 products on its register, of which there are 21,000 devices and 27,000 drugs, of which only 3,500 are registered prescription-only products. The drugs manufacturing and marketing is regulated by stringent regulations, based on which companies need to submit an application to the regulatory authority for approval.
What is eCTD?
As the name suggests the eCTD is an electronic, module-based regulatory application format that acts as an interface within the pharmaceutical industries to transfer regulatory information. This technical format was developed and maintained by the International Conference on Harmonisation (ICH).
eCTD submission is usually composed of -
- Directory Structure
- Content files
- XML eCTD instance
The preliminary job of eCTD for regulatory submissions is to harmonize the layout and format of pharmaceutical submission documents, thereby enabling easier and faster filing and reviews of applications.
Australia embracing eCTD
Before Australia embraced this system, eCTD format was already adopted by some of the world’s largest regulatory bodies, including the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and Japan’s Ministry of Health, Labor and Welfare (MHLW).
It was only in 2012 Australian eCTD framework was widely used by TGA in Australia so as to work closely with the pharmaceutical industry.
Australia has been accepting paper and non-eCTD Electronic Submissions (NeeS) format of applications. NeeS, is an electronic application however it is way behind the modern type of application, which is implemented in many other parts of the globe, namely eCTD. Australia is now moving forward in an effort to go ahead and implement the eCTD format.
In the recent past, Australia has inked an agreement with an eCTD software vendor to receive, review and process electronic (eCTD) applications for the entry of prescription medicines and other therapeutic products on to the ARTG. The nation is working closely with the stake holders and plans to implement this modern format for application by the end of 2014.
TGA uses docuBridge software
The TGA has agreed to use the docuBridge software solution to process electronic applications.
What is docuBridge software?
This software solution is widely accepted standard system by both high end and start-up companies along-with regulatory agencies. This software is used to compile, publish, manage and review electronic submissions. Besides, docuBridge consolidates with NeeS, paper submissions, VNeeS, AMNOG all global eCTD software standards.
TGA makes use of docuBridge to receive, analyze and initiate electronic applications for the entry of prescribed medicines and other therapeutic products on to the Australian Register of Therapeutic Goods (ARTG).
Presently the regulatory industry has acquired considerable amount through an array of volumes of paper documentation that are submitted to support their applications. Lorenz is now their official sponsor for docuBridge. Lorenz directly works with therapeutic device regulators and pharmaceutical companies across the globe to aid the transition to electronic submissions.
The TGA has already consulted with stakeholders to make this system commonplace in the regulatory world, as it helps improve the quality, whilst reducing the cost of medicines applications submitted to the TGA.
What else is going around?
Earlier this year, the Therapeutic Goods Administration (TGA) – Australia’s medicines regulator had announced that there wouldn’t be any amendment in the making that classified biosimilar products following a proposal made by the World Health Organization to modify the naming standard that defined Australian policy.
Initially TGA had proposed that biosimilars should be referred using Australian Biological Name (ABN) that is followed by the prefix “sim(a),” where “(a)” is the 3-letter code for the biosimilar assigned by WHO’s INN committee.
However, as per a press release released in January this year by TGA, the policy that was designed as per the INN (International Non-proprietary Names) standard wouldn’t be implemented any more.
It was then followed by WHO whose new policy ‘Biological Qualifier – An INN Proposal’ modified the previously naming council for biosimilars.
The present modification has this to offer,
“Biosimilars will use the Australian Biological Name without a specific biosimilar identifier suffix, for example a biosimilar to the reference product Neupogen filgrastim would be ‘TRADENAME’ filgrastim.”
And as far as Australian eCTD is concerned, Regulators at Therapeutic Goods Administration (TGA) will now take a breather owing to this change in the process. However, pharmaceutical companies will be faced with a big challenge in moving to this non-familiar format of submissions. Industries will now have to align themselves with various new technical requirements. We might soon witness Australia implementing a more convenient and highly effective format of eCTD.
