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Good Pharmacovigilance Practices (GVP) are a set of guidelines designed to enhance the execution of pharmacovigilance across the European Union. These guidelines apply to marketing authorization holders (MAHs), the European Medicines Agency (EMA), and medicines regulatory authorities in EU member states. GVP encompasses both centrally authorized medicines through the EMA and those authorized at the national level. The GVP guidelines by EMA are divided into 12 modules that cover major pharmacovigilance processes. In this blog, we will explore these modules and their significance in keeping patients safe.
Module I: Pharmacovigilance Systems
This module sets the quality standards for pharmacovigilance systems, ensuring they effectively monitor and manage drug safety. Pharmaceutical companies use these systems to detect, evaluate, and prevent adverse effects of their products, ensuring continuous safety surveillance even after market approval.
Module II: Pharmacovigilance System Master File (PSMF)
The PSMF is a comprehensive document that provides an overview of the pharmacovigilance system's performance and status. It includes information about the QPPV, organizational structure, IT systems, PV processes, quality activities, and any outsourced activities. Submission of a PSMF is mandatory for marketing authorization applications in the EU.
Module III: Pharmacovigilance Inspections
EU competent authorities conduct inspections to verify that the marketing authorization holder’s (MAH’s) pharmacovigilance systems comply with regulatory standards. These inspections aim to ensure that resources are adequate, compliance issues are resolved, and necessary actions are enforced to safeguard public health.
Module IV: Pharmacovigilance Audits
Pharmacovigilance audits are mandated by the EMA to ensure that the pharmacovigilance systems are robust and effective. These audits should be risk-based and conducted regularly, including independent audits to provide an objective assessment of the system’s compliance with quality standards.
Module V: Risk Management Systems
Upon drug approval, companies must implement a risk management plan (RMP) that outlines the drug’s safety profile, identifies risks, and specifies pharmacovigilance activities to detect new adverse reactions. The RMP is continuously updated as more safety data becomes available.
Module VI: Reports of Suspected Adverse Reactions
This module guides the collection, management, and submission of adverse reaction reports to ensure that all relevant data is captured and analysed. It helps competent authorities and MA holders determine the nature of the reports and take appropriate action.
Module VII: Periodic Safety Update Reports (PSURs)
PSURs are critical for assessing the ongoing risk-benefit balance of a drug after it has been authorized. They provide updated safety information, which is reviewed by competent authorities to identify any changes in the risk-benefit profile.
Module VIII: Post-Authorization Safety Studies (PASS)
PASS is conducted to investigate the safety of a drug in real-world conditions, confirming its safety profile and the effectiveness of risk management measures. These studies can be initiated by the EMA or the MAH and are reviewed by the PRAC.
Module IX: Signal Management
This module covers the processes for detecting, evaluating, and managing drug safety signals. It ensures that any potential safety issues are identified and reported promptly to regulatory authorities for further investigation.
Module X: Additional Monitoring
Certain drugs require additional monitoring to collect more data on their safety profile. These drugs are marked with a black triangle (▼), indicating that they are subject to closer scrutiny by regulatory authorities and healthcare professionals.
Module XV: Safety Communication
Effective safety communication ensures that critical safety information is disseminated to healthcare professionals and the public. This module outlines the responsibilities of MAHs, competent authorities, and the EMA in coordinating and sharing safety information.
Module XVI: Risk Minimization Measures
This module provides strategies for minimizing the risks associated with drug use. It includes guidance on planning, implementing, and assessing the effectiveness of risk minimization measures to ensure they adequately protect patients from adverse reactions.
Key differences between the GVP modules with additional information
| Aspect | Details |
| GVP Modules XI to XIV | These modules are null since their planned topics are addressed by other guidance documents on the European Medicines Agency (EMA) website |
| Modules XV and XVI | These modules are not part of the original GVP modules but are included in the current framework. Module XV covers safety communication, and Module XVI deals with risk minimization measures. |
| Product- or Population-Specific Considerations | Some modules have specific chapters for vaccines, biological medicinal products, and the pediatric population. |
| Annexes and Additional Information | The GVP modules include annexes that provide additional required information such as definitions, templates, other guidelines, and policies on access to EudraVigilance data. |
| Updates and Revisions | The GVP modules are regularly revised and updated. For example, Module I was first published in 2012 and last updated in 2017. |
| Scope and Focus | Each module has a specific scope and focus. For instance, Module I establish quality objectives for pharmacovigilance systems, while Module VI covers collecting, managing, and submitting reports of suspected adverse reactions. |
| Regulatory Requirements | The GVP modules are designed to support the implementation of pharmacovigilance legislation and ensure compliance with regulatory requirements. For example, Module II requires the submission of a pharmacovigilance system master file (PSMF) as part of marketing authorization applications. |
| Stakeholder Participation | The GVP modules are open to contributions from any member of the EU regulatory network, non-regulatory stakeholders, and the public. This ensures that the guidelines remain dynamic and responsive to changing health system requirements. |
| Comparison with EAEU-GVP | The GVP modules have been compared with the Eurasian Economic Union (EAEU) Good Pharmacovigilance Practices (GVP) guidelines. While the EAEU-GVP rules are similar to the EU-GVP modules, they do not include updates from recent revisions and have specific requirements tailored to the EAEU Common Market for Medicine. |
Conclusion
Good Pharmacovigilance Practices (GVP) modules are essential for ensuring the safety and efficacy of medicinal products in Europe. By understanding and adhering to these guidelines, pharmaceutical companies can play a crucial role in protecting public health and expediting the approval process. A seasoned regulatory expert, Freyr is committed to helping life sciences companies direct the complexities of GVP compliance, ensuring that their products meet the highest standards of safety and efficacy.
Author: Sonal Gadekar
