Active Pharmacovigilance in 2026: Methods and Use

Active Pharmacovigilance in 2026: Methods and Practical Use

Updated 15 July 2026. Active pharmacovigilance is the targeted search for safety information in a defined population. Unlike spontaneous reporting, it systematically contacts patients or healthcare professionals or routinely analyses healthcare data rather than waiting for voluntary reports.

When active surveillance is needed

• new medicines, vaccines and technologies with limited exposure;
• rare, delayed or population-specific risks;
• use during pregnancy, in children, older adults or people with comorbidities;
• signal confirmation and quantitative risk assessment;
• post-authorisation commitments and evaluation of risk-minimisation measures;
• large treatment or immunisation programmes.

Main methods

• Cohort event monitoring — systematic follow-up after treatment initiation.
• Sentinel sites — enhanced high-quality data collection at selected healthcare facilities.
• Registries — follow-up of a disease, product, pregnancy or special population.
• Electronic health-record and claims analyses — outcome identification and comparative risk assessment.
• Targeted follow-up — structured collection of information on predefined important risks.
• Digital tools — applications, electronic questionnaires and wearables with appropriate validation and data protection.

Active versus passive surveillance

Spontaneous reports are valuable for early detection of unusual events but cannot reliably estimate incidence because of under-reporting and an uncertain exposed population. Active surveillance provides a clearer denominator and standardised data, but requires a protocol, resources, quality management and bias control. The approaches are complementary.

Real-world data and ICH M14

RWD-based safety studies should prespecify the research question, assess data fitness, control confounding and misclassification, document data provenance and transformations and ensure reproducibility. These principles are reflected in ICH M14.

Practical checklist

1. Define the safety concern, population, outcomes and regulatory purpose.
2. Select a method capable of answering the question and write a protocol.
3. Justify sample size and follow-up duration.
4. Validate exposure and outcome definitions.
5. Establish consent, confidentiality and data-protection processes.
6. Control follow-up completeness, missing data and bias.
7. Prespecify analyses, escalation rules and integration into signal management, the RMP and PSUR/PBRER.

What is current in 2026?

World Health Assembly resolution WHA79.11 and WHO’s global smart pharmacovigilance strategy encourage digital tools and real-world data. EMA is expanding RWE through DARWIN EU, while ICH M14 provides harmonised methodological expectations for RWD-based safety studies.

Official sources

• WHO: Pharmacovigilance
• WHO: Pharmacovigilance strategies
• EMA: Real-world evidence
• EMA: DARWIN EU

How PharmExpert can help

PharmExpert supports active-surveillance protocols, data-source selection, quality-controlled collection, analysis and integration of findings into risk management.

This article is for general information. Each project must comply with applicable regulatory, ethical and data-protection requirements.