Standard Operating Procedure for Monthly Regulatory Intelligence Review Meetings

Department	Regulatory Affairs
SOP No.	RA/2026/642
Supersedes	NA
Page No.	1 of X
Issue Date	09/04/2026
Effective Date	09/04/2026
Review Date	09/04/2028

Purpose

This SOP establishes a controlled and standardized process for conducting monthly regulatory intelligence review meetings to ensure timely identification, evaluation, and integration of regulatory changes impacting the organization’s compliance and submission strategies. It supports the control objective of maintaining up-to-date regulatory knowledge, mitigating compliance risks, and facilitating informed decision-making across regulatory and quality functions.

Scope

This SOP applies to all regulatory intelligence activities related to the monitoring, collection, analysis, and communication of regulatory updates and policies affecting pharmaceutical products, manufacturing processes, quality systems, and compliance requirements. It covers inputs from global and regional regulatory agencies, internal departments, and external sources. This SOP excludes daily regulatory tracking tasks and specific submission management procedures outside the context of monthly review meetings. It is applicable to the Regulatory Affairs department and interacting quality, manufacturing, and compliance units.

Responsibilities

The Regulatory Intelligence Coordinator is responsible for preparing and distributing meeting materials. Regulatory Affairs Managers organize and facilitate the meetings. Subject Matter Experts and representatives from QA, QC, Manufacturing, and Compliance participate in discussions and provide input. Quality Assurance reviews meeting outcomes for alignment with quality systems. Records Management ensures all meeting documentation is archived as per policy.

Accountability

The Head of Regulatory Affairs holds overall accountability for ensuring the SOP is implemented effectively, remains compliant with applicable regulations, and is periodically reviewed. This role is also responsible for addressing escalations arising from regulatory intelligence findings and verifying the effectiveness of the meeting process in managing regulatory risk.

Procedure

1. Preparation

The Regulatory Intelligence Coordinator compiles regulatory updates from validated sources including regulatory agency websites, bulletins, and subscription services at least two weeks prior to the scheduled monthly meeting. Updates should cover all relevant regions and product categories within the company’s portfolio.

2. Prerequisites

Ensure availability of current regulatory intelligence databases and tools, access to internal communication platforms, and a designated meeting room or virtual meeting platform secured well in advance.

3. Meeting Notification and Agenda

A formal meeting invitation along with the proposed agenda and compiled intelligence report is distributed to all participants at least seven calendar days before the meeting date. The agenda should include review of new and ongoing regulatory developments, impact assessments, action items, and compliance status updates.

4. Conducting the Meeting

The Regulatory Affairs Manager begins the meeting by reviewing objectives and previous meeting action items. The Coordinator presents the compiled regulatory updates, followed by open discussions involving cross-functional stakeholders to assess impact and required actions. Proposed responses and responsible departments are documented clearly.

5. In-Process Controls and Verification

During the meeting, a designated scribe records minutes capturing key discussions, decisions, assigned responsibilities, and timelines. The Regulatory Affairs Manager ensures all regulatory changes are evaluated for applicability and conformity with internal standards and compliance requirements.

6. Acceptance Criteria

The meeting is considered successful if all relevant regulatory updates are reviewed, impacts identified, and clear action plans with owners and timelines are established. Any pending information or clarifications are clearly noted with follow-up plans.

7. Deviation Handling

If significant regulatory changes arise unexpectedly or cannot be incorporated within the meeting timeframe, these are escalated immediately to the Head of Regulatory Affairs for urgent assessment and interim communication.

8. Approvals and Documentation

Final approved meeting minutes are compiled within five business days and circulated to all attendees and relevant stakeholders. Documentation is reviewed and signed off by the Regulatory Affairs Manager and retained as controlled records.

9. Record Retention and Closure

All records, including meeting agendas, minutes, regulatory intelligence reports, and action item logs are archived per the organization’s document retention policy. Periodic reviews of action item completion status are conducted at subsequent meetings to ensure closure.

This procedure ensures a controlled, thorough, and timely approach to regulatory intelligence management supporting organizational compliance and regulatory readiness.

Abbreviations

RA – Regulatory Affairs

QA – Quality Assurance

QC – Quality Control

SOP – Standard Operating Procedure

GMP – Good Manufacturing Practice

Documents

1. Monthly Regulatory Intelligence Report (Annexure-1)
2. Meeting Agenda Template (Annexure-2)
3. Meeting Minutes Template (Annexure-3)

References

EU GMP Annex 11 – Computerised Systems

ICH Q10 Pharmaceutical Quality System

FDA Guidance for Industry – Regulatory Submissions

ISO 9001:2015 Quality Management Systems

Company Quality Manual and Document Control Procedures

Version

1.0

Approval

Prepared By
Checked By
Approved By

Annexures

Annexure-1: Monthly Regulatory Intelligence Report

Purpose: To document and communicate compiled regulatory updates from relevant agencies and sources for monthly review meeting.

Date	Source	Region	Regulatory Update Summary	Impact Assessment
01/03/2026	FDA	USA	Updated guidance on serialization requirements for pharmaceutical labeling.	Medium impact – requires label revision and system update.
15/03/2026	EMA	Europe	New draft guideline on stability testing of herbal products issued for comment.	Low impact – currently no herbal products in portfolio.
20/03/2026	MHRA	UK	Post-Brexit changes to batch release certification process announced.	High impact – require SOP updates and staff training.

Annexure-2: Meeting Agenda Template

Purpose: To structure and guide the monthly regulatory intelligence review meetings.

Meeting Date:	DD/MM/YYYY
Time:	HH:MM AM/PM
Location/Platform:
Facilitator:
Attendees:
Agenda Items
1.	Review of previous meeting minutes and action items
2.	Presentation of regulatory intelligence report
3.	Discussion of regulatory changes and impact assessment
4.	Action item assignment and timelines
5.	Any other business
6.	Schedule next meeting

Annexure-3: Meeting Minutes Template

Purpose: To record discussions, decisions, and assigned actions during monthly regulatory intelligence review meetings.

Meeting Date:	DD/MM/YYYY
Time:	HH:MM AM/PM
Location/Platform:
Facilitator:
Recorder:
Attendees:

Agenda Item	Discussion Summary	Decisions Made	Action Items	Responsible Person/Department	Deadline
Review of previous meeting minutes	All previous actions reviewed. Two items pending.	Pending actions escalated.	Follow up on pending CAPAs.	Quality Assurance	31/04/2026
Presentation of regulatory intelligence report	FDA serialization update highlighted.	Initiate label update project.	Update SOP and inform labeling vendor.	Regulatory Affairs	15/05/2026
Discussion of regulatory changes	MHRA batch release changes discussed in detail.	Revise batch release SOP.	Conduct staff training on new process.	Manufacturing, QA	30/05/2026

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
09/04/2026	1.0	Initial issue	New SOP creation