regulatory ectd

regulatory ectd viewer

Electronic Common Technical Document (eCTD) Viewer

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.

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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).

What is the Functionality of eCTD Viewer Software?

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.

FAQs About the eCTD Submission Process

  • Which applications require an eCTD?: Under updated FDA guidance as of April 2018, the following applications must be done by eCTD: New drug applications (NDAs); certain investigational new drug applications (INDs); abbreviated new drug applications (ANDAs); certain biologics license applications (BLAs); and all subsequent submissions of these types of applications, including drug master files (DMFs), amendments, supplements and reports.

  • What about Type III DMFs? For Type III DMFs, the electronic submission requirement takes effect May 5, 2019.

  • What about paper-based CTD submissions? As of 2017, submissions not in eCTD format cannot be filed or received by the FDA unless exempted from the requirement.

  • What modules are included in eCTD submissions? The eCTD submission has five modules:

    • Module 1: Administrative information and prescribing information

    • Module 2: CTD summaries

    • Module 3: Quality information

    • Module 4: Nonclinical study reports

    • Module 5: Clinical study reports

  • What impact does moving to eCTD have on the drug submission process? With applications being submitted electronically, it is easier for the FDA to review data, approve new drugs and monitor drugs after they go on the market.

  • Is the eCTD submission process more universally accepted? Because pharmaceutical regulatory agencies around the world use the eCTD format, electronic submissions offer users a more simplified process and greater global harmonisation for agencies and manufacturers.

Tips for Acing eCTD Publishing

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.

eCTD Publishing Stages

The eCTD publishing and electronic submission filing journey begins with these three steps:

  1. Contact the FDA electronic submission support team by email to inform the agency of your intent to submit an eCTD and request a sample number.

  2. Set up and test an Electronic Submissions Gateway (ESG) account through the FDA website. The FDA also provides a helpful checklist for setting up a WebTrader account with the ESG.

  3. Submit a sample eCTD.

MasterControl’s eCTD Publishing Solution

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.

Learn more about MasterControl eCTD Publishing

MasterControl and the FDA

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).

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