eCTD (Elektronik Ortak Teknik Doküman) Kapsamı ve Genel Hükümler
eCTD (Electronic Common Technical Document): Scope and General Provisions
The TİTCK presentation covers the scope and general provisions of the eCTD (Electronic Common Technical Document), the official file format enabling applicants to submit information and documents to health authorities in the licensing and lifecycle processes of medicinal products for human use in a secure, holistic electronic environment compliant with international standards. It ensures that quality, safety and efficacy data potentially comprising tens of thousands of pages are presented in a defined hierarchy and order, reviewed by assessment authorities, and archived in accordance with legal regulations.
The presentation introduces the eCTD v4.0 standards and architecture: a next-generation submission standard developed in line with global regulatory needs and current technological requirements. It abandons the rigid, hard-to-modify folder structures of earlier versions, moving to a flexible, data-driven, internationally harmonized infrastructure for managing information, documents and processes. Documents are handled not merely as files but as trackable data packages within the system via smart tags and identifiers.
For sponsors and CROs, the implications are significant: documents already approved and submitted to the Authority can be reused in subsequent licensing procedures by reference only, without physical re-upload, preventing duplicate submissions, avoiding data confusion, and yielding high storage and archiving savings. Multiple documents in a licensing dossier can be updated, modified or withdrawn simultaneously in a single operational step; administrative material errors in classification, naming or headings can be corrected promptly within the system without recreating and resubmitting the document. Deficiency notifications, requests for additional information and official correspondence between the applicant and the assessment authority are conducted directly on the eCTD infrastructure, minimizing the time and administrative workload in dossier preparation, pre-review and expert assessment, thereby maximizing operational efficiency both inside and outside the Authority.