The Common Technical Document (CTD) was adopted by the International Conference on Harmonisation in 2000. Its purpose is to provide life science companies with a common structure for registering drugs for human use to regulatory agencies. The U.S. Food and Drug Administration (FDA) was the first agency to adopt CTD as a common structure for receiving product registrations from companies. The eCTD is the electronic format of the CTD with a few additional requirements. The eCTD viewer is software for viewing the details of electronic submissions and to prep drug applications to be published in the correct format. The eCTD is the standard format for submitting applications, amendments and reports to the FDA’s Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER).
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eCTD viewer software can load and process any eCTD submissions as long as sequences conform to ICH and regional eCTD specifications. Such software can process multiple eCTD submissions, load multiple PDFs, process multiple advanced searches, and save life cycle and metadata as CSVs. eCTD viewer software reduces submission review times, increases the response times to regulatory agency requests, and helps facilitate faster approvals for pharmaceutical companies’ products.
Before you begin eCTD publishing, it’s important to be aware of common grounds for which the FDA rejects eCTD submissions. These include duplicate submissions; applications submitted to the wrong center (CDER versus CBER); mismatched application types; invalid submission file types; and nonstandard eCTD publishing formats. An awareness of these potential hurdles and ensuring that your submission process includes a close attention to detail can help you avoid these setbacks. Your main options for eCTD publishing are: doing it all in-house using an eCTD publishing-capable electronic document management solution (EDMS); through an outsource partner; or using an eCTD vendor. The first option, employing an in-house, digital solution, provides a pharma manufacturer with the greatest value and the most control over the process.
The eCTD publishing and electronic submission filing journey begins with these three steps:
MasterControl offers unsurpassed, end-to-end eCTD document management through its eCTD publishing and document management solution. MasterControl eCTD publishing solution enables users to generate submission-ready documents, and control, track and collect them within the system’s centralized, secure integrated electronic platform.
Designed to meet the most rigorous document management and control standards required by regulatory agencies, MasterControl’s eCTD solution provides virtual collaboration on submissions documentation and extends automated routing, escalation, approval and revision control of documents. Its automated system and tracking of access share rights makes MasterControl’s eCTD publishing process more efficient than other systems and reduces any burden on IT personnel.
MasterControl and its partner, i4DM, have served as the quality management system (QMS) providers for the FDA’s Office of Regulatory Affairs since 2009. They also serve as QMS providers for the Division of Pharmaceutical Analysis, part of the FDA’s Center for Drug Evaluation and Research (CDER).