Regulatory Affairs: SOP for Submission Package Naming Conventions and File Structure – V 1.0

Standard Operating Procedure for Submission Package Naming Conventions and File Structure

Department	Regulatory Affairs
SOP No.	RA/2026/698
Supersedes	NA
Page No.	1 of X
Issue Date	12/04/2026
Effective Date	12/04/2026
Review Date	12/04/2028

Purpose

This Standard Operating Procedure (SOP) defines the uniform methodology for applying naming conventions and structuring submission package files to ensure consistency, traceability, and regulatory compliance. Effective control of submission package file names and their hierarchical organization supports efficient review, retrieval, and archival activities across functional areas involved in regulatory submissions.

Scope

This SOP applies to all regulatory affairs personnel and related departments involved in preparation, quality control, review, and dispatch of electronic submission packages for clinical, marketing authorization, and post-approval regulatory activities. It covers all types of submission documents and files regardless of format or product type. This SOP excludes internal working documents and non-submission related files.

Responsibilities

The following roles are responsible for adherence to this SOP: Regulatory Affairs Authors and Preparers, Submission QC Analysts, Reviewers, Supervisors overseeing regulatory documentation, and Document Control personnel ensuring system compliance.

Accountability

The Head of Regulatory Affairs is accountable for ensuring implementation, compliance, and periodic review of this SOP. They oversee escalation of relevant issues and ensure periodic effectiveness assessments are conducted and documented.

Procedure

1. Preparation and Prerequisites: All submission package files must be created or converted into acceptable regulatory formats as per current regulatory guidelines prior to naming and structuring. Ensure the submission type, jurisdiction, and submission date are clearly identified.

2. Naming Conventions: Each file and folder name must follow a standardized format incorporating fixed elements such as submission identifier code, document type abbreviation, version or revision number, date in YYYYMMDD format, and file purpose descriptor. For example, RA_Submission01_Module3_ClinicalStudyReport_V2_20260412.pdf.

The naming must exclude special characters that may affect system processing. Consistency in abbreviations and numbering sequence across the submission package is mandatory.

3. File Structure: Submission packages are to be organized into a hierarchical folder structure reflecting the regulatory dossier format (e.g., eCTD modules or CTD sections). Each folder must nest documents logically by type and sequence. Root folders represent major dossier sections; subfolders subdivide by document category or study.

4. Quality Checks: Prior to final compilation, conduct a Submission QC to verify naming compliance, complete file inclusion, and correct folder placement. Utilize checklists and automated validation tools where available.

5. Approvals and Documentation: Only approved and final versions of documents shall be included in the submission package. Document preparers and reviewers must sign off QC checklists and maintain version control logs in accordance with regulatory and company policies.

6. Deviations and Corrections: Any deviation from the naming or structure conventions must be documented, investigated, and approved by the responsible specialist. Corrections must be implemented before submission dispatch.

7. Record Retention and Closure: Complete submission package files, QC checklists, approval records, and deviation documentation must be archived in the company’s document management system under secure, retrievable conditions and retained as per regulatory and corporate record retention policies.

8. Training and Updates: Relevant personnel shall be trained on this SOP and notified promptly of any revisions. Updates to naming conventions or file structures must reflect current regulatory or technological changes.

Abbreviations

eCTD: Electronic Common Technical Document
QC: Quality Control
RA: Regulatory Affairs
SOP: Standard Operating Procedure
CTD: Common Technical Document
PDF: Portable Document Format

Documents

The following documents are essential to implement and document compliance with this SOP:

Submission Package File Naming Convention Checklist (Annexure-1)
Submission Package Folder Structure Template (Annexure-2)
Submission QC Checklist and Sign-off Form (Annexure-3)

References

ICH M4: Common Technical Document for the Registration of Pharmaceuticals for Human Use;
FDA eCTD Guidance for Industry (latest version);
EMA Guidance on Electronic Submissions (latest updates);
Internal Quality Management System Documentation Control Procedures;
Company Document Management and IT Security Policies.

Version

1.0

Approval

Prepared By
Checked By
Approved By

Annexures

Annexure-1: Submission Package File Naming Convention Checklist

Checklist Item	Yes/No	Comments
Are all file names compliant with prescribed naming format?	Yes
Are dates correctly formatted as YYYYMMDD?	Yes
Are prohibited special characters avoided in file names?	Yes
Is version/revision number included and accurate?	Yes
Are document type abbreviations consistent across the package?	Yes
Have all file names undergone QC review?	Yes

Prepared By: ___________________ Date: 12/04/2026

Checked By: ___________________ Date: 12/04/2026

Approved By: ___________________ Date: 12/04/2026

Annexure-2: Submission Package Folder Structure Template

Folder Level	Folder Name Example	Description
Root	Submission_RA001_20260412	Top level folder named with submission ID and date
1	Module_1_Administrative_Info	Administrative and cover letters
1	Module_2_Summary	Summaries and overviews
1	Module_3_Quality	Quality data and support documents
2	Clinical_Study_Reports	Subfolder in Module 5 for clinical reports
2	Nonclinical_Study_Reports	Subfolder for toxicology and safety data
1	Index_and_Introduction	Index files and general introduction docs

Annexure-3: Submission QC Checklist and Sign-off Form

QC Activity	Result	Comments
Verify all files present as per submission plan	Pass
Confirm file naming complies with SOP	Pass
Validate folder structure aligns with regulatory requirements	Pass
Check appropriate versions and approvals are included	Pass
Ensure no prohibited or incomplete files exist	Pass
Confirm signature and date fields completed	Pass

QC Performed By: ___________________ Date: 12/04/2026

Reviewed By: ___________________ Date: 12/04/2026