12 Good Pharmacovigilance Practices (GVPs) for 2023

Patient safety is at the heart of pharmacovigilance. So, pharmaceutical companies need to act when there’s a new potential adverse reaction to a drug. In this blog, we look at the 12 good pharmacovigilance practices (GVPs) you should follow in 2023 and beyond.

Good Pharmacovigilance Practices

What Are Good Pharmacovigilance Practices (GVPs)?

Before you can market a drug in a territory, you must prove the drug is safe to the regulatory authority. In the European Union (EU), the regulatory authority is called the European Medicines Agency (EMA). The EMA established good pharmacovigilance practices (GVPs) to streamline the performance of pharmacovigilance. If you intend to or are currently marketing pharmaceutical products in the EU, GVPs apply to you.

Understanding the 12 GVP Modules

There are 12 GVP modules labeled I to XVI, which cover major pharmacovigilance processes. (Module numbers XI, XII, XIII and XIV are null since the EMA already addressed their planned topics in other guidance documents.) Let’s look at each module and see how they play a part in keeping patients safe:

I. Pharmacovigilance systems and their quality systems
II. Pharmacovigilance system master file (PSMF)
III. Pharmacovigilance inspections
IV. Pharmacovigilance audits
V. Risk management systems
VI. Collection, management and submission of reports of suspected adverse reactions to medicinal products
VII. Periodic safety update reports (PSURs)
VIII. Post-authorization safety studies (PASS)
IX. Signal management
X. Additional monitoring
XV. Safety communication
XVI. Risk minimization measures

Module I. Pharmacovigilance Systems

Module I establishes quality objectives for pharmacovigilance systems to meet patient and public safety standards. It also offers guidelines for how each part of the PV process should be handled in order to meet those objectives.

Pharmaceutical companies use pharmacovigilance systems to determine if their drugs might have adverse effects. If so, they can utilize the data in the pharmacovigilance system to figure out how to prevent the side effects from occurring.

Even though drugs go through comprehensive clinical trials before approval, some side effects can materialize later. Therefore, organizations also use pharmacovigilance systems to track drug safety over time. That way, they can show their findings to regulatory authorities and alert the public when a new adverse event is detected and verified.

Module II. Pharmacovigilance System Master File (PSMF)

The pharmacovigilance system master file (PSMF) reports on the performance and status of the PV system used for a drug. Every PSMF must include insights on your company’s:

  1. Qualified person responsible for pharmacovigilance (QPPV)
  2. Organizational structure
  3. Computer system
  4. PV processes
  5. Quality system activities
  6. Delegated activities

Any pharma company that wants to sell a drug in the EU is required to apply for marketing authorization (MA), and all MA applications must include a PSMF.

Module III. Pharmacovigilance Inspections

Competent authorities from the EU will inspect your PV system to ensure it complies with the EMA’s guidelines. Pharmacovigilance inspections are meant to:

  • Ensure the marketing authorization holder has the resources to meet their PV requirements
  • Resolve any compliance issues that jeopardize public health
  • Enforce action when necessary

While competent authorities inspect pharmacovigilance systems to find risks and other potential gaps, they also conduct audits to ensure the system is effective.

Module IV. Pharmacovigilance Audits

The EMA legally requires a pharmacovigilance audit. The goal is to verify that a pharmacovigilance system can adequately perform activities.

Your organization’s MA holder must conduct regular risk-based audits to ensure the pharmacovigilance system follows the quality system requirements.

The EMA also requires an independent auditor to objectively audit your pharmacovigilance system and share the results with those responsible for the system.

Module V. Risk Management Systems

When a drug is approved, it’s on the basis that the benefits of the drug outweigh the risks. But at the time of authorization, not all adverse reactions and risks are known. Therefore, pharma companies create a risk management plan (RMP) to document the risk management system that aims to:

  • Identify the safety profile of the drug and emphasize the risks and missing information
  • Create a pharmacovigilance plan that identifies new adverse reactions
  • Implement a risk minimization plan

And as more information about the drug’s safety profile emerges, the RMP will adapt to those changes.

Module VI. Reports of Suspected Adverse Reactions to Medicinal Products

The EMA’s guidance on the collection, management and submission of reports of suspected adverse reactions to medicinal products is intended for:

  • Competent authorities
  • MA holders
  • The EMA

The pharmacovigilance system helps collect reports of adverse reactions so competent authorities and MA holders can determine if the reports are solicited or unsolicited.

Module VII. Periodic Safety Update Reports (PSURs)

Periodic safety update reports (PSURs) provide a drug’s risk-benefit at the time of the post-authorization phase. Competent authorities may review the PSURs within 70-90 days of the data lock point (day 0) to see if the risk-benefit balance has changed.

Module VIII. Post-Authorization Safety Studies (PASS)

A post-authorization safety study (PASS) is a document that:

  • Identifies a safety hazard of a drug
  • Confirms the safety profile of a drug
  • Considers the effectiveness of risk management measures

The study can be initiated by the EMA or the MA holder. The results are then viewed by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC).

Module IX. Signal Management

Signal management refers to the evaluation, reporting and timelines of drug safety issues. For example, if a drug can cause heart problems, the pharma company needs to send a signal to the EMA within 30 days.

Regulatory tracking software can identify adverse reactions, decide if you need to send a safety signal, and help you understand the deadlines associated with each signal.

Module X. Additional Monitoring

In some instances, the EMA requires additional monitoring for certain drugs that may have adverse reactions emerge after they were authorized. The EMA maintains a list of drugs that must undergo additional data collection, and they are identified with an inverted equilateral black triangle ▼.

Module XV. Safety Communication

Safety communication refers to how MA holders, competent authorities, and the EMA must communicate and coordinate safety information about drugs authorized in the EU. Module XV specifically focuses on new safety information that’s important for the general public to know.

Module XVI. Risk Minimization Measures

Module XVI provides guidance on how to plan and implement risk minimization measures, which aim to prevent or reduce adverse reactions to drugs. It also offers information on the tools needed for risk minimization and how to tell if they’re effective.


GVPs help keep patients informed about new adverse reactions to drugs. Pharma companies work closely with the EMA to ensure any developments are addressed swiftly so that the public can make informed decisions about the drugs they take.

Tracking Portal by Intagras can help you manage the safety signal information in your PSMF report with ease. Contact us to learn more about this pharma tracking software.

Need regulatory tracking help? Talk to us.

Have questions? Need more info? Talk to one of our experts or request a demo of our Tracking Portal today.