A New Era Dawns
by Mary Sgammato
January 2008
As the march toward universal electronic submission of regulatory documents continues, regulators and pharmaceutical manufacturers are learning how to best implement the new technology.
Even though the efficiencies of electronic data collection (EDC) have been clearly demonstrated, and electronic submissions to regulatory agencies are on the rise, the majority of those submissions continue to be paper-based. This is likely to change, however, as both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) move toward requiring universal adoption of electronic submissions in the not-too-distant future.
There are clear and convincing arguments to be made for the elimination of paper submissions. Regulators must spend a disproportionate amount of time deciphering the data and standardizing it for analysis. Updates to the data are time-consuming and present management and logistical challenges for international trials involving multiple countries and sites. And, the sheer volume of documents can fill a warehouse, creating a storage problem easily resolved by a transition to an electronic format.
Both the FDA and the EMEA are planning to require electronic submissions by the end of 2007 and most likely will require electronic Common Technical Document (eCTD) as the standard format for these submissions. The FDA will require all electronic submissions to the Center for Drug Evaluation and Research to be in eCTD format after December 31, 2007, although paper submissions will still be accepted. An eCTD system uses extensible markup language (XML) backbone files that were developed through the International Conference on Harmonisation (ICH) to facilitate standardized submissions of new drug applications in Europe, the United States, Japan and Canada.
A Collaborative Transition
Regulators are taking a careful and incremental approach to the implementation of eCTD standards and publicly acknowledge some of the challenges involved in this transition. The FDA first issued detailed guidance on using eCTD specifications in October 2005 and has updated the guidance periodically to provide more specificity and clarify the agency’s thinking on this topic.
Similarly, the EMEA has carefully considered some of the legal issues that may preclude the complete elimination of paper records from the application submission process. According to Claire Edwards, project manager at the EMEA, in London, U.K., it is sufficient for the EMEA to hold all records centrally, but certain member states may have legal requirements that mandate paper records be stored at the local site at which data are collected. Edwards says that the EMEA is gathering all of its 27 member states’ requirements. “If we find a problem, we’ll work around it,” she says. “There may always be a need to retain certain paper documents locally, [but] it’s certainly not an obstacle to the transition to eCTD.”
The EMEA and the FDA also seem to understand the need for a fair amount of lead time to allow pharmaceutical companies to develop eCTD capabilities or find a vendor to perform this function. Although the complete transition to eCTD is a large undertaking, the good news is that companies do not need to build from the ground up. “There’s no need to develop an in-house eCTD tool when there is a variety of effective tools already available in the market for all different sizes of enterprises,” Edwards says. She also says that the EMEA is looking to make common validation tools more accessible “to ensure consistency in the validation approach.”
Planning is Key
Electronic submissions, and the likely adoption of eCTD as the common format for these submissions, are on the horizon. Companies that are actively planning for the conversion to an electronic-only approach will find themselves well positioned to adapt to this new environment and reap the benefits and efficiencies that eCTD offers.
At Solvay Pharmaceuticals, planning is already underway. Linda Self, Solvay’s global director of regulatory technical services, in Marietta, Ga., USA, sees eCTD as having a positive impact in many aspects of clinical trial conduct. She cites the use of standard file naming conventions, the ability to have a current view of the state of an application at any point in time and the opportunity to obtain a global internal perspective when managing multi-site trials as significant tangible benefits of eCTD.
Self also acknowledges the challenges involved in the transition to eCTD. For example, she already sees some divergence in the requirements put forth by regulatory bodies, which she says could lessen the positive impact of this approach. Self hopes that all of the regulatory agencies come to a common agreement on requirements for electronic submissions to help ensure optimal outcomes.
“Change always poses some challenges,” Self says. “It’s important to take a long-term perspective and make strategic decisions” on how to best adapt to this new environment, she says. “We see this not only as an opportunity to meet agency requirements, but also as a chance to assess our internal procedures.” And, regarding the costs associated with new infrastructure, training and tracking of metadata and other technical concerns, according to Self, “It’s the cost of doing business.”
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