Embracing eCTDs and Electronic Submissions

Pharma IQ

In the past few years, the very way pharmaceutical organisations submit their applications for drug approval has become an essential issue to consider. While paper-based submissions have been a mainstay in the industry for a long time, changing trends and the rising use of IT means that some drug authorities now only take such documentation in electronic formats.

While the electronic common technical document (eCTD) has grown to be a particularly accepted way for such information to be passed on, other submission styles are also used by a range of organisations. Figures from software provider Liquent have suggested that the idea of passing on such data digitally is being increasingly accepted by those involved in life sciences.

The 2009 Liquent Regulatory Affairs Trends Survey looked into issues including regulatory trends related to the adoption of eCTD and other formats. It revealed that 88 per cent of pharmaceutical regulatory professionals polled expect to increase their use of publishing software over the next two years. In addition, almost a third are planning to outsource study report writing, which marks an increase from the figure of 22 per cent recorded in 2008.

Discussing the findings, Liquent vice-president of strategy Jim Nichols, suggested they provide major evidence that many people are getting to grips with electronic formats.

"Every year our regulatory trends survey attracts a varied group of respondents from a diverse number of organisations throughout the globe, and this year was no different," he explained.

"The findings reaffirm our belief that the continued standardisation of submission and data formats is making it easier to share critical information both internally and with the regulatory authorities."

With life science professionals in the US and other western countries getting to grips with eCTD and other related formats, it is likely to only be a matter of time until authorities further afield embrace the concepts. A recent deal announced between GlobalSubmit and Arable Corporation could help such trends on their way.

It is hoped a partnership between the pair will team up GlobalSubmit's expertise in product systems with Arable's understanding of the regulated healthcare product market. A key aim of the agreement is to ensure that the firms are able to provide suitable solutions and guidance to regions which are only currently in the process of taking up electronic standards.

According to the firms, a growing number of areas are embracing a paperless future as they look to ensure their own operations are compatible with potential or existing partners in other countries already using electronic systems.

Rahul Mistry, chief executive of GlobalSubmit, said: "With the rise of global clinical trials and the need for additional regulation to combat counterfeit drugs, it is important that regulators standardise on how they receive and process information.

"Standardising how countries receive and process needs to fit with each country's regulation, capabilities and cultural differences."

When considered together, the research from Liquent and the partnership between Arable and GlobalSubmit showcase in their own way that electronic submissions face a bright future in the pharmaceutical and healthcare industries.

In addition, both highlight the key benefit that companies are hoping for – an increase in standardisation which will boost the future prospects of pharmaceutical organisations as a whole.

All in all, it appears that such trends mean that, while eCTDs and related formats remain a relatively new concept, they are set to play a key role in the industry for a number of years to come.