Pharmacovigilance

Pharmacovigilance in the European Union (EU) is governed by a comprehensive regulatory framework designed to ensure the ongoing safety and effectiveness of medicinal products. EU pharmacovigilance is based on Regulation (EU) No. 520/2012, which provides operational guidelines for pharmacovigilance activities in line with Directive 2001/83/EC and Regulation (EC) No. 726/2004. Additionally, the Good Pharmacovigilance Practices (GVP) guidelines outline the requirements for marketing authorization holders (MAHs), regulatory authorities, and healthcare professionals to collect, evaluate, and act upon safety information. The primary objective of these regulations is to detect, assess, and prevent adverse drug reactions and other risks associated with medicinal products, ensuring that patient safety remains a priority throughout a product’s lifecycle. 

Key aspects of pharmacovigilance: 

1. Establish and Maintain a Pharmacovigilance System Master File (PSMF): The PSMF has to document the pharmacovigilance system, including responsibilities, processes, and safety monitoring activities. 
2. Appointment of a Qualified Person for Pharmacovigilance (QPPV): Every marketing authorization holder has to have a QPPV responsible for the overall pharmacovigilance system and compliance. 
3. Adverse Drug Reaction (ADR) Reporting: All adverse reactions must be reported within to the EudraVigilance database. 
4. Signal Detection and Management: Implement a structured process to detect and assess potential safety signals using EudraVigilance, literature screening, and other data sources. 
5. Periodic Safety Update Reports (PSURs): Submit PSURs at defined intervals, including a benefit-risk analysis, regulatory actions, and safety concerns. 
6. Risk Management Plans (RMPs): Develop and maintain RMPs outlining risk minimization measures and additional monitoring requirements for medicinal products. 
7. Post-Authorization Safety Studies (PASS): Conduct PASS studies when required to gather additional data on safety, efficacy, or risk minimization. 
8. Compliance with Good Pharmacovigilance Practices (GVP): Follow GVP modules to ensure systematic safety monitoring and adherence to best practices. 
9. Literature Monitoring: Continuously monitor global and local medical literature for new safety signals or ADR reports related to authorized medicinal products. 
10. Electronic Submission of ICSRs: Ensure Individual Case Safety Reports (ICSRs) are electronically submitted to EudraVigilance following ICH-E2B(R3) format. 
11. Pharmacovigilance Agreements (PVAs): Establish and maintain PV agreements with partners and distributors to ensure aligned safety reporting obligations. 
12. Quality Management System (QMS) for Pharmacovigilance: Implement standard operating procedures (SOPs), audits, CAPA processes, and continuous training for pharmacovigilance personnel. 
13. Signal Validation and Assessment: Regularly analyse safety data, validate potential risks, and report emerging signals to PRAC and competent authorities. 
14. Additional Risk Minimization Measures (aRMMs): Implement safety education materials, controlled distribution, or special prescribing restrictions when required. 
15. Safety Communication and Updates – Issue Direct Healthcare Professional Communications (DHPCs), labelling updates, and safety alerts as needed. 
16. Responding to Regulatory Authority Inquiries: Provide timely responses to questions, risk evaluations, and additional data requests from EMA or National Competent Authorities. 
17. Audits and Inspections Readiness: Maintain documentation and be prepared for pharmacovigilance inspections by competent authorities. 
18. Risk-Based Pharmacovigilance Audits: Conduct internal audits and risk-based assessments to identify gaps and improve the pharmacovigilance system. 
19. Patient and Healthcare Professional Engagement: Encourage ADR reporting from patients and healthcare professionalswhile ensuring awareness of pharmacovigilance responsibilities. 
20. Crisis and Risk Management Planning: Develop crisis management plans for handling urgent safety issues, product recalls, and regulatory non-compliance situations.