Types of Pharmacovigilance in 2026: Complete Overview

Types of Pharmacovigilance in 2026: Complete Overview

Updated 15 July 2026. Modern pharmacovigilance combines passive reporting, active surveillance, real-world data, clinical safety, signal management and risk assessment. The appropriate method depends on the product, population, lifecycle stage and regulatory question.

1. Passive pharmacovigilance

Spontaneous reports from patients, healthcare professionals and companies support early detection of rare or unexpected events. Limitations include under-reporting, variable data quality and the lack of a precise exposure denominator.

2. Active pharmacovigilance

Active surveillance systematically searches for cases through cohort event monitoring, sentinel sites, registries, targeted follow-up and structured patient contacts. WHO distinguishes product-based, setting-based and event-based active surveillance.

3. Clinical-trial pharmacovigilance

This includes AE, SAE and SUSAR management, medical assessment, urgent safety measures and the annual DSUR under the protocol, ICH E6(R3), ICH E2A/E2F and national requirements.

4. Post-authorisation studies

PASS and other non-interventional studies quantify risks, identify risk factors and evaluate risk-minimisation effectiveness. RWD studies should follow ICH M14 principles for data fitness, confounding control, transparency and reproducibility.

5. Signal pharmacovigilance

Signals arise from ICSRs, literature, studies, registries and real-world databases. The process covers detection, validation, confirmation, analysis, prioritisation, assessment and recommendations. A signal is a hypothesis requiring evaluation, not proof of causality.

6. Population- and product-specific surveillance

• vaccines and AEFI;
• biological medicines and traceability of brand and batch;
• pregnancy, breastfeeding and in-utero exposure;
• paediatric and geriatric populations;
• rare diseases and advanced therapies;
• medication errors, overdose, abuse, misuse and off-label use.

7. Digital and smart pharmacovigilance

Digital forms, electronic health records, RWD platforms, analytics and AI can accelerate safety work but require validation, privacy protection, quality control, explainability and human oversight. WHO’s global smart pharmacovigilance strategy emphasises risk-based prioritisation, collaboration and measurable impact.

Selecting the right combination

1. Define the safety question and regulatory purpose.
2. Consider risk frequency, latency and available exposure.
3. Select fit-for-purpose data sources and study design.
4. Ensure quality, ethics, privacy and bias management.
5. Integrate results into signals, the RMP, PSUR/PBRER and regulatory actions.
6. Evaluate the effectiveness of resulting measures.

Official sources

• WHO: Pharmacovigilance strategies
• WHO: Active surveillance
• EMA: Signal management
• WHO: Global smart pharmacovigilance strategy

How PharmExpert can help

PharmExpert helps select surveillance strategies, implement ICSR and signal processes, and prepare PASS, PSMF, RMP and quality-system documentation.

This article is for general information. Specific obligations depend on the applicable jurisdiction.