Standard Operating Procedure for Global Submission Status Reporting

Department	Regulatory Affairs
SOP No.	RA/2026/614
Supersedes	NA
Page No.	1 of X
Issue Date	08/04/2026
Effective Date	08/04/2026
Review Date	08/04/2028

Purpose

This SOP defines the standardized process for collecting, verifying, consolidating, and reporting the status of global regulatory submissions to ensure timely and accurate communication across all regulatory functions. It supports compliance with regulatory requirements and facilitates effective tracking and management of submission activities to achieve transparency and accountability.

Scope

This procedure applies to all regulatory affairs personnel responsible for managing and reporting the status of global submissions related to pharmaceutical products, including dossier compilation, filing, approvals, and commitments. It covers submissions to health authorities worldwide and includes electronic and paper-based reporting systems. This SOP excludes submission content preparation and internal dossier creation procedures.

Responsibilities

Regulatory Coordinators are responsible for gathering status data from regional teams. Regulatory Managers oversee data accuracy and completeness. Quality Assurance reviews and approves the final consolidated report. The Document Control team ensures proper versioning and archiving of reports. Senior Management receives and reviews summarized status reports for strategic decision-making.

Accountability

The Head of Regulatory Affairs is accountable for the implementation, compliance, periodic review, and effectiveness of this SOP. This role is also responsible for escalation of any issues affecting the completeness or accuracy of submission status reporting and ensuring results are communicated across relevant stakeholders.

Procedure

1. Preparation: Regulatory Coordinators initiate the reporting cycle by notifying all regional regulatory teams of the upcoming status report due date and required submission categories.

2. Data Collection: Each regional team compiles submission status updates, including dossier filing dates, authority feedback, approval status, pending commitments, and next actions. Data must be collected using the standardized submission status tracking template.

3. Verification: Collected data undergoes initial review by Regulatory Coordinators to confirm completeness, consistency, and adherence to defined timelines. Any discrepancies or missing data must be queried and resolved promptly with the respective regional teams.

4. Consolidation: Verified data is consolidated into the global submission status report template, aligning all updates uniformly. Key data points include submission identifier, product, region, submission type, filing date, current status, and remarks on outstanding actions.

5. Review and Approval: The consolidated report is submitted to Regulatory Managers and QA for an in-depth review ensuring data integrity and regulatory compliance. Required corrections are incorporated before final approval.

6. Reporting and Distribution: Upon approval, the report is forwarded to Senior Management and key stakeholders via the predefined communication channels. Confidentiality and data security measures must be maintained in report handling.

7. Documentation and Record Retention: All communication, drafts, and finalized reports are documented and archived by Document Control according to the company’s documentation retention policy to allow audit readiness and traceability.

8. Deviation Handling: Any delays in reporting or data inconsistencies are documented as deviations and escalated to the Head of Regulatory Affairs for investigation and corrective action.

9. Continuous Improvement: Feedback from stakeholders and audit findings are used to update the reporting process and templates periodically, ensuring the SOP remains effective and aligned with regulatory expectations.

Abbreviations

RA – Regulatory Affairs
SOP – Standard Operating Procedure
QA – Quality Assurance
HAs – Health Authorities
Doc Control – Document Control

Documents

1. Global Submission Status Tracking Template (Annexure-1)
2. Consolidated Submission Status Report (Annexure-2)
3. Deviation Report Form (Annexure-3)

References

ICH Q10 Pharmaceutical Quality System, EMA Guideline on Regulatory Submissions, FDA Guidance for Industry on Electronic Submissions, Internal Quality Management System Procedures, 21 CFR Part 11 Compliance Requirements.

Version

1.0

Approval

Prepared By
Checked By
Approved By

Annexures

Annexure-1: Global Submission Status Tracking Template

Purpose: To collect standardized regional submission status data for timely consolidation.

Region	Product	Submission ID	Submission Type	Filing Date	Current Status	Comments
EMEA	Product A	SUB-EM-1023	Variation	15/03/2026	Under Review	Waiting for additional data request response
APAC	Product B	SUB-AP-2045	New Drug Application	22/02/2026	Approved	Approval granted on 05/04/2026
USA	Product C	SUB-US-3099	Supplement	01/04/2026	Pending	Scheduled for filing 10/04/2026

Annexure-2: Consolidated Submission Status Report

Purpose: To provide a comprehensive global overview of current submission statuses for management and regulatory oversight.

Submission ID	Product	Region	Submission Type	Filing Date	Status	Outstanding Actions
SUB-EM-1023	Product A	EMEA	Variation	15/03/2026	Under Review	Submit response to data request by 25/04/2026
SUB-AP-2045	Product B	APAC	New Drug Application	22/02/2026	Approved	N/A
SUB-US-3099	Product C	USA	Supplement	01/04/2026	Pending Filing	Filing scheduled on 10/04/2026

Annexure-3: Deviation Report Form

Purpose: To document any deviations encountered during submission status reporting and actions taken.

Deviation ID	Date of Deviation	Description	Root Cause	Corrective Actions	Status
DEV-2026-001	02/04/2026	Delay in receiving submission data from APAC region	Communication lag due to holiday period	Implemented early notification system and follow-up reminders	Closed
DEV-2026-002	05/04/2026	Inconsistent filing dates reported from USA team	Data entry error in regional spreadsheet	Provided data entry training and validation steps	In Progress

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
08/04/2026	1.0	Initial issue	New SOP creation