1.0 OBJECTIVE:
1.1 The objective of this Standard Operating Procedure is to define a structured and systematic approach for ensuring compliance with global pharmacovigilance regulatory reporting requirements applicable to medicinal products marketed by the company or managed through contractual pharmacovigilance responsibilities.
1.2 This SOP describes the process for identifying applicable regulatory reporting obligations, ensuring timely submission of safety reports to global health authorities, maintaining regulatory reporting compliance, and documenting all regulatory submissions in accordance with applicable guidelines including WHO Technical Report Series (TRS), EU Good Pharmacovigilance Practices (EU-GVP), and relevant national regulatory requirements.
2.0 SCOPE:
2.1 This SOP applies to all pharmacovigilance activities related to global regulatory safety reporting, including expedited and non-expedited reporting, periodic reporting, and safety-related regulatory communications.
2.2 This SOP is applicable to the Pharmacovigilance (PV) Department, Qualified Person for Pharmacovigilance (QPPV), Deputy QPPV, Regulatory Affairs (RA), Quality Assurance (QA), and any contracted partners involved in pharmacovigilance and regulatory reporting activities.
3.0 RESPONSIBILITIES:
3.1. Pharmacovigilance (PV) Department:
3.1.1 To identify and evaluate safety information requiring regulatory reporting in accordance with applicable global regulations.
3.1.2 To ensure timely preparation and submission of Individual Case Safety Reports (ICSRs) and other safety-related regulatory submissions.
3.1.3 To maintain up-to-date knowledge of global regulatory reporting timelines and requirements.
3.1.4 To maintain complete and accurate documentation of all regulatory safety submissions.
3.1.5 To provide oversight of global regulatory safety reporting activities.
3.1.6 To ensure that pharmacovigilance reporting obligations are fulfilled in a timely and compliant manner.
3.1.7 To approve and oversee safety reporting processes that have regulatory or compliance impact.
3.2. Regulatory Affairs (RA):
3.2.1 To monitor country-specific regulatory reporting requirements and communicate updates to the PV Department.
3.2.2 To support PV in regulatory submissions, authority communications, and follow-up correspondence.
3.2.3 To ensure alignment between regulatory submissions and marketing authorization requirements.
3.3. Quality Assurance (QA):
3.3.1 To verify compliance of regulatory reporting activities with Quality Management System requirements.
4.0 DEFINATIONS:
4.1 Global Regulatory Reporting: The submission of safety-related information to health authorities across different countries in accordance with applicable pharmacovigilance regulations.
4.2 ICSR (Individual Case Safety Report): A structured safety report describing an adverse event or adverse drug reaction in an identifiable patient.
4.3 Expedited Reporting: Regulatory submission of serious and unexpected adverse reactions within defined timelines.
4.4 Non-Expedited Reporting: Routine safety reporting submitted through periodic reports or scheduled submissions.
5.0 PROCEDURE:
5.1 Identification of Applicable Regulatory Reporting Requirements:
5.1.1 The PV Department shall identify applicable regulatory reporting obligations for each marketed product based on the country of authorization, type of product, and applicable regulatory framework.
5.1.2 Regulatory reporting requirements shall be reviewed periodically and updated whenever new regulations, guidelines, or authority communications are issued.
5.2 Classification of Safety Reports for Regulatory Submission:
5.2.1 All safety information received shall be assessed to determine whether it meets criteria for expedited or non-expedited regulatory reporting in accordance with applicable global regulations.
5.2.2 The PV Department shall ensure accurate classification of reports prior to submission.
5.3 Preparation and Submission of Regulatory Reports:
5.3.1 The PV Department shall prepare regulatory submissions in the required format and submit them within applicable regulatory timelines using authority-approved submission channels.
5.3.2 Where electronic submission is not available, alternative submission methods permitted by the authority shall be used.
5.4 Regulatory Communication and Follow-up:
5.4.1 All communications received from regulatory authorities related to safety reporting shall be reviewed and addressed promptly.
5.4.2 Follow-up information requested by health authorities shall be provided within defined timelines and documented accordingly.
5.5 Documentation and Record Maintenance:
5.5.1 The PV Department shall maintain complete records of all regulatory submissions, acknowledgements, and correspondence in a controlled manner.
5.5.2 All regulatory reporting documentation shall be retained in accordance with company retention policies and applicable regulatory requirements.
5.6 Monitoring of Compliance and Escalation:
5.6.1 The PV Department shall monitor regulatory reporting timelines to ensure compliance.
5.6.2 Any delay, deviation, or potential non-compliance shall be escalated immediately to QPPV and QA, and managed through the deviation and CAPA process.
6.0 REFERENCES:
6.1 WHO Technical Report Series (TRS) – PV guidance
6.2 EU Good Pharmacovigilance Practices (GVP)
6.3 Company QMS SOPs (Document Control, Training, Audit, Risk Management, Deviation & CAPA)
7.0 RECORDS:
Sr No. Title Document No.
1 Global Regulatory Reporting Log F/PV011/001 – 00
2 Regulatory Submission Tracker F/PV011/002 – 00
3 Regulatory Communication Log F/PV011/003 – 00
8.0 REVISION HISTORY.
Amendment Date: Update Summary Version No.
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