With the eCTD Specification and the regional Module 1 Specifications an exchange standard has been established that defines how regulatory information shall be passed from industry to regulatory authorities. The eCTD specifies the format and the structure of an electronic submission. To generate electronic drug applications the pharmaceutical industry uses special compilation software.
Actually, both industry and authorities have a vital interest to guarantee that a submission meets all requirements of the eCTD specification. EXTEDO provides EURS is Yours to regulatory authorities as well as applicants.
EURS is Yours is a multifunctional software solution that serves as an overall eCTD validation and retrieval software. It reports whether a submitted eCTD-based application conforms with the official interpretation of the eCTD format. Furthermore it provides access to submissions allowing the user to search, view or print any required regulatory document.
EXTEDO designed and implemented EURS is Yours as a standardised software solution to cover the EUropean Reviewing System specifications and the extensions to these specifications that have been gained by hands-on experience with eCTD dossiers in close cooperation with various regulatory authorities. EURS is Yours is especially designed for the validation, acceptance, import, review and maintenance requirements of the EMEA and associated national competent authorities (NCAs). It operates with basic hard- and software and can be integrated in any information system, keeping full functionality.
EURS is Yours is independently controlled by EMEA and NCAs. It will be regularly updated in the light of changes in the ICH eCTD Specification and/or EU Module 1 Specification, ICH-developments and further experience gained by the agency and authorities in the context of the EMEA driven eCTD Implementation Group.
EURS is Yours runs on various types of IT infrastructures (standalone, groupware) and provides:
• an intuitive and configurable user interface
• configurable validation requirements to verify eCTD compliance
• a very fast and accurate import procedure into a standard eCTD repository
• extremely fast and easy-to-use search functions based on full text, TOC entries, annotations or eCTD-based attributes
• easy-to-use application to improve electronic reviewing processes with an integrated, context-sensitive online-help
From the authority’s point of view the most important features of EURS is Yours are that it accesses submissions fast and smoothly and that it covers the entire life cycle management of a drug product.
This results in further benefits like:
• support of parallel work (inhouse and international)
• advanced features for validation, import, display, search and printing
• extensive audit trail,
• powerful navigating tools (hyperlinks, private and public comments, enhanced search)
Once an eCTD submission has been imported within EURS is Yours by the agency, its drug approval maintenance life cycle starts. Added, deleted, appended or replaced documents, i.e. every version-related change of the dossier, are visualised by self-explanatory icons. Submissions can be organized by certain Regulatory Activities which are representing the overall regulatory status of a drug product.
EURS is Yours allows different users access to one dossier simultaneously. Optionally a sophisticated caching mechanism (Central Repository) can be implemented especially for using EURS is Yours in internationally distributed working groups. This reduces network traffic and waiting periods. If wanted EURS is Yours can easily be integrated into state-of-the-art document management systems by using DMSconnect.