مواصفات الوحدة الإقليمية (الموديول 1) للمستند الفني الإلكتروني الموحد (eCTD) لدول مجلس التعاون الخليجي

This document specifies Module 1 of the electronic Common Technical Document (eCTD) for Gulf Cooperation Council (GCC).

This document should be read together with the ICH eCTD Specification to prepare a valid eCTD submission for GCC. The latest version of the ICH eCTD Specification can be found at: http://estri.ich.org

The ICH M4 Expert Working Group (EWG) has defined the Common Technical Document (CTD). The ICH M2 EWG has defined, in the current document, the specification for the Electronic Common Technical Document (eCTD). The eCTD is defined as an interface for

A brief glossary of terms (for the purpose of this document only) is indicated below:

Applicant: A pharmaceutical company or its agent that is submitting information in support of an application. Application: A collection of documents compiled by a pharmaceutical company or its agent in compliance with guidelines in order to seek a marketing authorization or any amendments thereof. CTD: Common Technical Document DTD: Document Type Definition eCTD: electronic Common Technical Document. An eCTD application may comprise a number of sequences. EWG: Expert

The ICH Common Technical Document (CTD) specifies that Module 1 should contain region specific administrative and product information. The content and numbering of Module 1 for GCC is specified in the latest version of the Guidance for Submission that can be found at http://www.sfda.gov.sa

It should be noted that for subsequent submissions in the lifecycle of a medicinal product, e.g. for a variation, not all of the above mentioned kind of documents need be included in Module 1. In addition, other items such as the rationale for variations and renewal