This year the research concentrates on four key areas: technology usage trends, including both submission publishing software and other desktop software; document management system usage; regulatory outsourcing trends; and regulatory trends including use or future use of the electronic common technical document (eCTD).
A quantitative web-based survey was conducted among 117 individuals from regulatory affairs departments at life science companies across the globe. Over half of the respondents are based in the USA, with the rest mainly from Europe, specifically the UK, France and Germany.
In terms of demographics, almost one third of respondents, 29percent, are in large pharmaceutical companies with revenues of more than US$1billion. Twenty-eight percent are in medium/small pharmaceutical companies with annual revenues of up to US$1billion. Of the rest, 13percent are in medical devices and 13percent in biotechnology companies.
In terms of handling regulatory activities, the survey found that 92percent of respondents make regulatory submissions and that 75percent of them handle all regulatory submissions internally.
Only 25percent outsource any regulatory activities. Of those that do, it has typically involved study report writing, printing and document scanning, and using a regulatory consultant to help with content.
The majority, 60percent, of respondents are currently using both paper and electronic processes to manage regulatory activities. This is similar to the finding in 2004. In the next two years, 76percent expect to still be submitting both, while only 9percent claim they will be submitting purely electronic output. However, three quarters of those currently using electronic submission software claim that their use of this technology is likely to increase in the future. Meanwhile, one third of those not currently using software are very likely to implement electronic submissions software into their process.
Clearly, the use of electronic technology has many advantages, not only in saving time and therefore money, but also in improving accuracy and therefore compliance. It also provides safe and affordable storage of critical documents.
So what do organisations want from new electronic document management solutions? The survey asked respondents to rank the following four features for their perceived importance:
- Managing the dossier publishing process.
- Managing multiple marketing applications.
- Managing documents to be included in a submission.
- Managing multiple product registrations.
Similar to the findings in 2004, all four were found to be of high importance. Notably, three quarters felt the management of documents to be included in a submission was of high importance. Meanwhile, over half stated electronic document management is very important to how people allocate their regulatory resources – again mirroring last year’s opinions. A further 45percent stated that submission lifecycle management is very important.
Document management
Confirming that the use of technology is on the increase as a means of managing documents, 70percent said they currently use a document management system, compared with 50percent in 2004. Sixty percent use Documentum as their primary system, down 15percent on 2004.
When asked to specify the primary benefits of a document management system, 51percent said control over versions of documents, 37percent said ease of access to documents, while a quarter cited ease of use, a centralised location for all documents, and security. Over half currently use submissions publishing software while three quarters claim their use of this will increase. Of those respondents not using submissions publishing software, 32percent are very likely to begin using software and 34 said that they would implement use of software within 1–2 years.
So automation is clearly on the rise. However, the secure access for everyone (SAFE) initiative has not yet taken hold in most companies surveyed. SAFE is designed to ensure that organisations that do adopt electronic technology for managing their content continue to adhere to strict codes of conduct concerning approvals and signatures. They must be able to prove that an electronic document existed at a specific point in time, exactly as represented, and that it was it signed by a particular user.
This initiative aims to address this critical requirement, so that, whatever system a company implements to establish its approval and signing process, it can ensure that, when a document is received by another party, it can be trusted, and its signature validated for authenticity.
Yet the survey found that only two per cent of respondents were addressing the SAFE initiative currently and almost three quarters are not sure whether or not they will implement the necessary technology in future, suggesting a lack of awareness of its importance. It is worth noting that the 23percent of respondents who do not plan to implement a digital signature process stated that it is not necessary for their company or industry.
Certainly, three quarters of respondents are not utilising a digital signature process for their submissions today and only just over a third definitely plan to implement this technology.
Regulatory trends
The majority of respondents, 69percent, are now aware of the changes to 21CFRPart11. This is the FDA rule that defines parameters by which pharmaceutical companies can author, approve, store, and distribute records electronically. Nevertheless, one third felt that the changes were only ‘somewhat clearly’ communicated. However, a level of uncertainty surrounds the implementation of the product information Management (PIM) project in Europe and the structured product labelling (SPL) project in the USA. These initiatives are attempts to: improve the method by which drug-labelling information gets submitted to regulatory agencies; reduce the amount of time life sciences companies require to prepare a labelling submission; and reduce the time take by the FDA to review such submissions.
SPL is a document markup standard approved by health level seven (HL7) and adopted by FDA as a mechanism for exchanging medication information. It is expected to be mandatory for pharmaceutical companies shortly.
Around a quarter of survey respondents stated that the labelling or submission publishing department would be responsible for creating/authoring SPL files within their organisation.
Knowledge about PIM appears to be low across the companies surveyed. Over half, 61percent, do not know whether their company is planning to implement PIM. Of the 20percent who will definitely not implement PIM, a third said their company was too small or didn’t have enough products to require PIM. Eighty-three percent do not know which department will be responsible for authoring the PIM files. Meanwhile, 89percent do not know how many labels they will submit in PIM format.
Three quarters of respondents plan to migrate to the eCTD, an international standard governing how applications are made for new drugs and biological products. This is up from 58percent last year. Similarly, a third of respondents plan to migrate to the eCTD within 10-18months, compared with 26percent in 2004.
One third have no concerns about this migration, whereas others are concerned about handling the change management within their organisation, training personnel on the new process, and whether or not agencies will accept the new electronic document. u
Jim Nichols, Vice President, Product Strategy and Marketing – Thomson Scientific, Liquent regulatory solutions division.
