Electronic Drug Application Initiative Faces Significant Adoption Challenges

McLean, VA, June 10, 2004 — A survey of twenty-one pharmaceutical, biotech, consumer, and generic drug firms, conducted by Booz Allen Hamilton, found that the majority of companies are taking a cautious approach to adopting the emerging electronic common technical document (eCTD) standard and have underestimated the investment required.

The eCTD is an important public/private initiative that is intended to simplify the submission and review process for new drugs with the Food and Drug Administration (FDA) and health agencies in other countries. Gaining efficiencies in the process will aid getting new treatments to market faster for patients that will benefit from them.

The majority of survey participants consisted of the top bio-pharmaceutical companies worldwide. While most companies had concerns about the impending standard, more than 85 percent saw the adoption of new standards as an opportunity to make major enhancements to their drug application programs that could reduce the time for worldwide drug application submissions and assist in reducing the regulatory agencies review time. Additionally, most participants are in the planning stage and hope to have a fully compliant infrastructure in place sometime in 2005 if the following occur:

1. Modifying the current draft standard to address critical outstanding issues of Life Cycle Management and EU mutual recognition.



2. Finalizing the draft standard so companies will commit to transforming their submission business processes and technology infrastructure.



3. Having several technology choices that have demonstrated full functionality, as no clear technology front-runners exist today.



4. Having a robust business case beyond Regulatory Compliance to assist in boardroom approval.

"The next 12-18 months will be critical for international regulatory bodies and industry to create a long-term solution that can be readily adopted and provide benefits to all." said Booz Allen Principal Stephen Gens. "The mandatory requirements of the CTD in several regions provided a boost to many submission programs and has benefited both the regulatory agencies and industry. The momentum gained by that success could be lost if some of the core issues in the eCTD are not resolved," said Gens.

To learn more about the in-depth survey conducted over the past five months, visit the Booz Allen Hamilton booth at the upcoming Drug Information Association show in June 2004 or contact Booz Allen Vice President Charley Beever or Booz Allen Principal Stephen Gens.