The eCTD guidelines are the set of specifications for a dossier for the registrations of medicines. As the common format agreed upon by the governing regulatory bodies in Europe, Japan, and the U.S., the eCTD guidelines serve as the technical requirements for submissions of applications to register pharmaceuticals for human use in those regions. A comprehensive and well-prepared eCTD guideline-adherent regulatory application is essential to smooth approval and registration processes and extremely beneficial in getting products to market sooner.
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Practical Purpose of the eCTD Guidelines
The eCTD guidelines, spelled out in the International Council for Harmonization (ICH) of Technical Requirements for Pharmaceuticals for Human Use, is not intended to indicate specifically required studies. Rather, the ICH Harmonized eCTD guidelines merely indicate an appropriate format for the data that have been acquired. The overall organization of the eCTD should not deviate from that which is outlined in the standard. According to the eCTD guidelines, the display of information should be unambiguous and transparent so that basic data can be readily reviewed and allow reviewers to become quickly oriented to the contents of the application.
Software that Simplifies Adherence to eCTD Guidelines
For pharmaceutical, biotech, and other life sciences companies, the registration of products follows immediately after a demanding regulatory approval process. And registering a new product in different countries is a complex, often protracted, and anxiety-fraught endeavor. Given that the drug development process itself has taken 10 to 15 years, these companies are already under the gun to get their drug products on the market and start achieving a return on their investments.
If your organization has been involved in registering pharmaceutical products before, you are undoubtedly familiar with these challenges that are commonly faced when attempting to follow eCTD guidelines:
The MasterControl Approach to Meeting eCTD Guidelines
Although the eCTD guidelines help companies avoid the need to generate and compile different registration dossiers, the tracking and document management components of the registration process are far too complex to handle with manual systems. To help alleviate the pains commonly associated with following the eCTD guidelines for registrations, MasterControl has designed a preconfigured building-block solution that allows companies to rapidly launch myriad registration projects in accordance with CTD guidelines. The MasterControl Registrations for eCTD™ software solution helps companies automate processes and meet the requirements of eCTD guidelines. The solution has been expertly designed to help life sciences companies streamline their control of critical timelines and essential documents.
Some of the features that allows users of MasterControl Registrations for eCTD to align with eCTD guidelines include:
To learn more about eCTD guidelines or MasterControl’s Registrations for eCTD solution, contact a MasterControl representative.