What are the eCTD Requirements in SFDA?

The electronic Common Technical Document (eCTD) has become a global standard for regulatory submissions, ensuring consistency, transparency, and efficiency. In Saudi Arabia, the Saudi Food and Drug Authority (SFDA) has carried out this mandate for all human drug applications since January 3, 2015. Prior to eCTD, all submissions were made in CTD (Common Technical Document) /NeeS (Non-electronic eCTD Submission) formats.
Companies that submit their filing applications must be familiar with the eCTD requirements (Modules 1–5) and the baseline submission process. This article briefly examines SFDA requirements and describes how baseline submissions become crucial in managing a dossier’s lifecycle. 

When is eCTD applicable?

• It is mandatory for all human drug applications, including pharmaceuticals, biologicals, biosimilars, new chemical entities, and generic drugs.
• Required for submissions for drug registrations, renewals, and variations.
• All old paper-based, CTD, and NeeS-formatted files must be converted to eCTD format.

What are the Important key Considerations?

• All dossiers must have proper sequencing throughout the product lifecycle management process.
• Version 1.5 is the latest Module 1 accepted specifications by the Gulf Cooperation Council (GCC) countries.
• A single dossier typically covers all dosage forms, strengths, and pack sizes of a drug product.
• Any changes made to dossiers should use the appropriate tracking attributes to reflect changes to the document.
• Communication in eCTD is one-way, from the company to the authority. The authorities send the inquiries out of the eCTD, and the applicants respond with a new eCTD sequence.
• The files containing the PDF documents in the eCTD dossier must be searchable and annotations enabled.
• Bookmarks and hyperlinking are encouraged where necessary without overuse.
• Passwords or any security codes in the dossiers may lead to its rejection. 
• Once submitted in eCTD, the SFDA does not allow reverting to other formats.
• Ideally, eCTD submissions shall cover Modules 1–5 (administrative and prescribing information, CTD summaries, Quality (CMC), Non-clinical and clinical study reports), unless it’s a generic drug, in which case only Modules M1, M2, and M3 are required for submission.

eCTD Structure

SFDA adopted the ICH eCTD structure with regional variations. The table below presents the requirements across all five modules.

You can also download a detailed checklist with comments from here: SFDA Drug Dossier Requirements.

Module Number	Module Sub Number	Requirements
Module 1: Regional Administrative Information	1.0	Cover Letter
	1.1	Comprehensive Table of Contents
	1.2	SDR Application Form
	1.3	Product Information: SPC, Labeling, Arabic/English Patient Information Leaflets (PILs), Artwork, Samples
	1.4	Information on Experts: Quality, Non-clinical, Clinical
	1.5	Environmental Risk Assessment: Non-GMO, GMO
	1.6	Pharmacovigilance: System & Risk Management Plan
	1.7	Certificates & Declarations: GMP, CPP, or Free-sales, COAs (drug substance/product, excipients), Alcohol/Pork declarations, TSE, Patents, DMF access letters
	1.8	Pricing: Price List & Related Documents
	1.9	Responses to Questions
Module 2: CTD Summaries	2.1	TOC of Modules 2–5
	2.2	Introduction
	2.3	Quality Overall Summary (Drug Substance & Product)
	2.4	Non-clinical Overview
	2.5	Clinical Overview: Development rationale, efficacy, safety, benefit–risk
	2.6	Non-clinical Summaries: Pharmacology, Pharmacokinetics, Toxicology
	2.7	Clinical Summary: Biopharmaceutics, PK/PD, Efficacy, Safety, Synopses
Module 3: Quality	3.1	TOC of Module 3
	3.2.S	Drug Substance: Manufacture, Controls, Characterization, Stability
	3.2.P	Drug Product: Development, Manufacturing, Specifications, Stability
	3.2.A	Appendices: Facilities, Adventitious Agents, Novel Excipients
	3.2.R	Regional Information
	3.3	Literature References
Module 4: Non-Clinical Study Reports	4.1	TOC of Module 4
	4.2	Study Reports: Pharmacology, Pharmacokinetics (ADME), Toxicology
	4.3	Literature References
Module 5: Clinical Study Reports	5.1	TOC of Module 5
	5.2	Tabular Listing of Clinical Studies
	5.3	Clinical Study Reports: Biopharmaceutics, Human PK/PD, Efficacy, Safety, Post-marketing
	5.4	Literature References

What is Baseline Submission in eCTD?

Baseline submission is the resubmission of the latest approved and valid documents in the eCTD format. The baseline sequence must not contain any new data and hence does not undergo scientific review by SFDA. Instead, it merely establishes a current dossier, a clean starting point for lifecycle management.

A baseline submission is mandatory when moving from CTD or NeeS formats to eCTD. Products registered through the SDR system as eCTD do not require baseline eCTD submissions.

Why is it Important?

• It provides authorities, such as the SFDA, with a starting point for lifecycle management of eCTD.
• Ensures consistency and traceability for future submissions.
• Makes the change from CTD/NeeS to eCTD format easier.

Baseline Submission Scenarios

Case	Sequence No.	Submission Description	Submission Type	Submission Unit	Related Sequence
NeeS/CTD to eCTD	0000	Baseline Submission	None	Reformat	–
	0001	Variation	var-type2	–	0000
	0002	Response to Questions	var-type2	Response	0001

Conclusion

The adoption of the eCTD by the SFDA has modernized regulatory submissions in Saudi Arabia, allowing easy tracking and the accumulation of changes and regulatory cycles within a single, connected file asset. Companies and regulatory professionals can also use a single database or quality system to track historical changes to their products.

The eCTD process can be time-consuming; it provides an efficient and standardized documentation format for both regulatory authorities and applicants. Pharmaknowl is committed to delivering fast-track eCTD submission services, ensuring high-quality, compliant, and timely application submissions through our team of experienced experts. Contact us for more information.

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