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Remote control

Take time to perfect the electronic submissions process as attention to detail is crucial

books_hammerHalf of all electronic regulatory licence application submissions to the health authority in France are being rejected for failing to meet Non-eCTD (Common Technical Document) electronic Submissions (NeeS) format criteria. This sobering finding was uncovered at a recent conference in Brussels on electronic submission standards, covering eCTD and NeeS – considered the interim step before moving to full eCTD submission. It serves as a reminder that there is no magic bullet to speed the transition away from paper applications.

This fact confirmed two key points that many knew already: that attention to detail remains as critical as ever, despite the growing adoption of electronic dossiers, and that many pharma companies are still finding this a challenge.

Currently, two-thirds of all electronic submissions to the French health authority, AFSSAPS, are in the NeeS format, an electronic standard that most life sciences companies in Europe should have adopted as a minimum by now. Germany, a large and important market, removed its requirement for paper dossiers from March 2010, leaving Finland as the only major European country still requiring paper submissions.

While some health authorities initially enforced informal validation of NeeS formatted submissions, there was not a single harmonised set of criteria against which to measure NeeS dossiers. This situation changed in August 2009 when specific validation criteria were introduced. However, failure to conform to the new published standards is widespread, with poor formatting and failure to meet basic validation standards common.

This is costing pharmaceutical companies both time and money, as they re-work the submission format and incur delays in having their submissions reviewed and approved. If dossiers are falling at the first hurdle, it means they are not even reaching the eyes of the reviewers.

The problem is particularly acute where pharma organisations are reliant on modestly-staffed local affiliates to manage marketing and regulatory submissions in that country. Their resources are likely to be overstretched already, without the additional burden of adapting to electronic formatting.

The importance of affiliates is growing, too, with companies' growing global presence, increased merger activity, and more extensive collaboration with international partners. Expansion of this nature broadens access to new markets, but brings a host of challenges, not least the need to understand the intricate differences between regions.

In addition, attracting and keeping the right talent can be difficult, with staff turnover at affiliate organisations sometimes as high as 25 to 30 per cent, and electronic publishing specialists hard to find in smaller countries. It is no surprise, then, that some of these partners are having problems meeting local NeeS and eCTD requirements.

Central control
It is likely that to address the problem they will have to absorb some level of central control. However, this demands greater integration, collaboration and visibility across their various international outposts, with common IT platforms connected across global boundaries, allowing data to be shared and giving HQ full sight of global submissions activities across a product's life cycle.

Specialist software can then be deployed, allowing work sharing between the centre and the affiliate companies as one possible working model. Alternatively, using a specialist service provider to manage national electronic submissions is a low-risk option for companies with limited resources.

Keeping track of the European submissions landscape is a full-time job for already overburdened submissions personnel. Knowing how many paper copies are needed or whether a pure eCTD submission is acceptable in each of the 27 EU countries can be a challenge, simply because the situation is continually being revised.

Positive strategy
The good news is that, with a clear and positive strategy, there is much to be gained from making the effort to get submissions right first time. Electronic submissions management offers drug companies numerous operational benefits, including:
• Radically reduced duplication and greater content accuracy, owing to the ability to reuse or repurpose approved material
• Reduced labour, as paper dossiers are phased out or eliminated
• Speed: filing electronically can sometimes be done online via a secure web portal, depending on the health authority
• Better workflow and version control of documents
• Elimination of the cost of paper and physical distribution
• Ease of document and content search, access and sharing across teams (even if colleagues are remote or external to the company)
• Easy, automatic document backup.

Now that electronic submissions have been embraced by most local authorities as a means of accepting submissions, drug firms have an unprecedented opportunity to abandon their paper documentation. Potentially, this could halve the work involved, drive down internal costs and boost speed to market.

These early days offer crucial piloting time, where pharmaceutical firms large and small have a chance to refine processes and perfect techniques. Where internal skills and resources, or time- scale, are an issue, particularly at an affiliate level, organisations can enlist the help of specialist service providers. Their role is to provide tailored consultancy and step-by-step support as firms make the transition to either their own electronic submissions publishing software, or a hosted software service. Getting it right will take time, which is why working closely with expert advisers is the safest and most efficient way.

Setting expectations is vital. While electronic submissions management, particularly in its most developed form, the eCTD, promises to transform document authoring, publishing and management, the benefits will not be felt overnight. It takes time to train staff, and to get the initial documents right. At first, the long-term process gains may seem to be outweighed by start-up problems.

This is effort worth expending, however. Attention must be paid to document structure and file naming so that otherwise hefty submission documents, running to thousands of pages, can be broken down into distinct, easily searchable sections. A thorough approach to document granularity will pay dividends later, enabling revisions and updates to be submitted and processed without the need to re-send an entire document.

Tracking and managing submissions across the drug lifecycle will be crucial, too. One of the primary advantages of electronic submissions is their scope for eliminating redundancy from processes and content, by re-using core, pre-approved content wherever possible, and editing and re-sending only that which is new. This not only saves time, but also protects companies from the potential risk incurred when the health authorities look over previously approved material with fresh eyes.

While paper has not yet been entirely consigned to the recycling bin, firms that persist in printing before sending their submissions may now find themselves out of sync with health authority standards, the purpose of which is to smooth and accelerate the review process. Rather than panicking or worrying about getting it wrong, actively engage in discussions with the relevant health authorities during this early transition period. They are likely to be sympathetic since they, too, are facing substantial change as they migrate their own internal processes to eCTD.

Scale the learning curve now, and the benefits will follow sooner rather than later. With the right help in the right places at the right time, the process will be accelerated, offering your organisation genuine market advantage. In a persistently difficult market, it is a rare business that can afford to turn such opportunities down.

The Author
Kate Wilber is director of regulatory services, ISI Europe

To comment on this article, email

22nd June 2010


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