Standard Operating Procedure (SOP) for Regulatory Post-Marketing Surveillance
Purpose:
The purpose of this SOP is to establish guidelines and procedures for the effective management of post-marketing surveillance activities in compliance with regulatory requirements. This SOP ensures the collection, assessment, and reporting of post-marketing safety information to ensure the ongoing safety and efficacy evaluation of marketed products.
Scope:
This SOP applies to all personnel involved in regulatory affairs, pharmacovigilance, medical affairs, quality assurance, and other relevant departments responsible for post-marketing surveillance activities within the organization.
Responsibilities:
3.1 Regulatory Affairs Department:
Develop and implement post-marketing surveillance procedures in compliance with regulatory requirements.
Monitor and review post-marketing safety information received from various sources.
Prepare and submit post-marketing safety reports to regulatory authorities as required.
Collaborate with cross-functional teams to address post-marketing safety-related queries or requests from regulatory authorities.
3.2 Pharmacovigilance Department:
Establish a pharmacovigilance system to capture and evaluate post-marketing safety data.
Collect, assess, and report adverse events, medication errors, and other safety-related information in accordance with regulatory requirements.
Conduct signal detection and evaluation activities to identify potential safety concerns.
Collaborate with the Regulatory Affairs Department to provide necessary data and documentation for post-marketing safety reports.
3.3 Medical Affairs Department:
Monitor and evaluate scientific literature and other relevant sources for safety-related information.
Conduct safety data review and analysis to support the ongoing safety evaluation of marketed products.
Provide medical expertise and support in the assessment of post-marketing safety data.
Collaborate with the Regulatory Affairs Department to address medical inquiries or safety-related queries from regulatory authorities.
3.4 Quality Assurance Department:
Conduct internal audits and inspections to ensure compliance with regulatory requirements and internal quality standards for post-marketing surveillance activities.
Review and approve post-marketing safety reports to ensure accuracy, completeness, and compliance.
Assist in addressing any regulatory findings or non-compliance issues related to post-marketing surveillance.
Procedure:
4.1 Post-Marketing Safety Data Collection:
4.1.1 Establish a robust system for the collection of post-marketing safety data, including adverse events, medication errors, and other safety-related information.
4.1.2 Define procedures for the receipt, documentation, and data entry of post-marketing safety information from various sources, such as spontaneous reports, literature, and safety databases.
4.2 Post-Marketing Safety Data Assessment:
4.2.1 Conduct the assessment and evaluation of post-marketing safety data, including the identification and evaluation of potential safety signals.
4.2.2 Perform causality assessment to determine the relationship between the reported events and the marketed products.
4.2.3 Conduct periodic safety data review to identify trends, patterns, or emerging safety concerns.
4.3 Post-Marketing Safety Reporting:
4.3.1 Prepare and submit post-marketing safety reports to regulatory authorities in compliance with regulatory requirements and timelines.
4.3.2 Ensure accurate and timely reporting of adverse events, including expedited reporting for serious and unexpected events.
4.3.3 Maintain records of post-marketing safety reports, correspondence with regulatory authorities, and follow-up activities.
4.4 Signal Detection and Management:
4.4.1 Establish procedures for the detection, evaluation, and management of potential safety signals.
4.4.2 Conduct signal detection activities using data mining techniques, literature review, and other signal detection tools.
4.4.3 Evaluate potential signals and determine the need for further investigation or action based on predefined criteria.
4.5 Communication and Collaboration:
4.5.1 Collaborate with cross-functional teams, including medical affairs, regulatory affairs, and quality assurance, to address safety-related queries or requests from regulatory authorities.
4.5.2 Communicate relevant safety information to internal stakeholders, such as product development teams, senior management, and marketing departments.
4.5.3 Collaborate with external stakeholders, including healthcare professionals and regulatory authorities, for the exchange of safety information and updates.
4.6 Compliance and Quality Assurance:
4.6.1 Conduct internal audits and inspections to ensure compliance with regulatory requirements and internal quality standards for post-marketing surveillance.
4.6.2 Review and approve post-marketing safety reports to ensure accuracy, completeness, and compliance.
4.6.3 Address any regulatory findings or non-compliance issues related to post-marketing surveillance and implement appropriate corrective actions.
Abbreviations Used (if any):
SOP: Standard Operating Procedure
AE: Adverse Event
PV: Pharmacovigilance
PMS: Post-Marketing Surveillance
ICSR: Individual Case Safety Report
EMA: European Medicines Agency
FDA: Food and Drug Administration
MAH: Marketing Authorization Holder
Documents:
Post-Marketing Surveillance Procedures
Adverse Event Reporting Forms and Templates
Post-Marketing Safety Reports
Audit and Inspection Reports
Regulatory Correspondence and Approvals
Reference (if any):
International Conference on Harmonisation (ICH) guidelines for Pharmacovigilance
Applicable regulatory requirements and guidelines for post-marketing surveillance in the respective countries or regions
SOP Version: [Specify SOP version number and date of the latest revision]
Note: This SOP should be periodically reviewed and updated as necessary to align with changes in regulations, industry best practices, or organizational requirements. It is crucial to ensure compliance with regulatory requirements and the timely reporting of post-marketing safety information. Any deviations from this SOP should be documented, reviewed, and approved by the appropriate personnel. Regular training and awareness programs should be conducted to ensure employees are familiar with their roles and responsibilities in regulatory post-marketing surveillance. Additionally, staying updated with changes in regulations and guidelines is essential for the effective management of post-marketing safety activities.
