Saudi Food and Drug Authority (SFDA) – Moving Towards The Acceptance of Electronic Submissions
Shakul Hameed – eCTD Regulatory Submissions Network http://ectdregulatorysubmissionsnetwork.blogspot.com/ & shakulbio@gmail.com
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Introduction:
An electronic Submission (or eSubmission) is a set of registration files submitted in electronic format to Health Authorities. The main reasons for submitting eSubmission to improve the submission review process, increase accuracy of the submission and decrease the total costs.
The Saudi Food and Drug Authority (SFDA) is working with eSubmission projects, Recently SFDA has released Guidance for Submission (Version 3.0) and Module 1 eCTD Specification guidance Version 1.0 for GCC (Gulf Cooperation Council). In both the guidance SFDA has mentioned about their requirements of eSubmission and their future plan to implement the eSubmission standards in step by step basis.
SFDA started to accepting NeeS (Non-eCTD electronic submission) format for human medicine submissions, However they are planning to make NeeS format become mandatory starting from 01 September 2012, this is an interim step and SFDA will announce their plan about moving towards only eCTD Submissions.
SFDA requested their applicants should follow the M1 eCTD Specification for Gulf Cooperation Council (GCC), Guidance for Submission documents and ICH CTD guidance to prepare their NeeS format application. ICH CTD specifies that the Module 1 should contain regional specific administrative and product information. The content and numbering of GCC Module 1 information specified in the Guidance for submission (version 3.0) document and for other reaming modules (Module 2 to Module 5) applicant can refer the ICH Common Technical Document (CTD).
For NeeS Submission the eCTD folder structure is used with the addition of TOC’s (Table of contents) as appropriate. For the folder structure and file naming convention information applicant should follow the ICH Granularity and ICH, GCC eCTD file naming convention documents. Applicants need to ensure that all the documents should properly bookmarked and hyperlinked as per the SFDA requirements because all the NeeS submission navigation will happen through TOC’s, Bookmarks and Text Hyperlinks.
The PDF documents should be 1.4 version or higher than that and the total file or folder path should not exceed more than 180 characters. Some of the documents needs to be text searchable (Eg: Cover Letter, Product Information etc…), and some of the documents do not need to be text searchable (Eg: Certificate, Licenses etc.). SFDA currently not supported the electronic signature however they are working in long term strategies in order to accept electronic signatures in future.
Technical Validation of NeeS submission:
The technical validation of a NeeS is a separate activity and takes place irrespective of the type of the submission.
A NeeS format must pass the technical validation, if there is any error in the submission need to fix and send an updated NeeS submission by applicant.
The following items checked during Technical Validation of NeeS dossier.
- Virus Check
- Compliance with General requirements (Eg: PDF file Properties)
- Compliance with the eCTD folder structure and naming convention.
- Bookmarks and Hyperlinks
- Security settings or password protection
eCTD submission:
An eCTD is the electronic version of the CTD. The structure, folder and file names correspond to those of the CTD. The eCTD contains some additional technical components compare with NeeS, which enable the life cycle of the individual file in the application, and the life cycle of the product itself, to be managed.
An eCTD has the following components: Folder structure, contents (files) and XML backbone. The folder structure has a hierarchical organization reflecting that of the CTD, and it holds the scientific and technical contents of the eCTD (divided into many files which are the same as those in the non-eCTD’s, Usually in PDF format). The XML backbone is recognizable as “index-xml” at the root level of the submission folder of an eCTD and supports the following main functions.
- It provides a hyperlinked TOC (Table of contents of the entire submissions (Module 1 to Module 5) while reviewing the submission by web browser).
- It provides descriptive information (“metadata”) on the files that make the actual contents of the eCTD
Module 1 Specification and Structure:
The GCC Module 1 eCTD Specification covers all the GCC countries (they are Bahrain, Kuwait, Oman, Qatar, Republic of Yemen and Saudi Arabia). In the specification guidance SFDA has clearly mentioned all the regional (module 1) eCTD components like meta data information, sequence number, related sequence number, submission type, GCC countries specific documents and country codes.
The GCC Module 1 architecture is similar to that module 2-5 of the ICH eCTD Structure. Comprising directory structure and a backbone with leaves. The backbone must be valid XML document according to the GCC Regional Document type Definition (DTD). The GCC regional DTD defines metadata at the submission level in the form of envelop.
There is no any update about GCC eCTD validation criteria, SFDA soon will update about their eCTD Validation documents. To find more information about GCC Module 1 information kindly refer the GCC Module 1 eCTD specification guidance (version 1.0).
Submission Dispatch Process to SFDA:
Applicant needs to be submit their soft copy of dossier (eCTD or NeeS) along with a hard copy (Paper based) only Module 1 information. The electronic submission needs to submit only in CD or DVD. Currently CD and DVD ISO 9600 are acceptable media by SFDA. For more information about the submission dispatch process and requirements (like CD label information, security setting) refer the SFDA Guidance for submission (version 3.0) document.
References:
1) SFDA Guidance for Submission (V 3.0) – http://www.sfda.gov.sa/NR/rdonlyres/085092A4-01B2-45CC-A526-3734D3BECC1D/0/Guidance_for_Submission_v_3.pdf
2) GCC Module 1 eCTD Specification (V 1.0) - http://www.sfda.gov.sa/NR/rdonlyres/2615EEAF-6DA5-410E-A786-8B5787333A7C/0/industry_pr1.pdf
3) Common Technical Document by Aziz DIOP - http://www.sfda.gov.sa/NR/rdonlyres/8ACF9CDE-12F8-4596-BBB5-0F55ADD4B16D/0/GCC_Module_1_Specifications.pdf
wow this was a crazy explanation, but a good one! thanks!
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