Pharmacovigilance & Regulatory Affairs Glossary

Key terms and definitions used in drug safety monitoring and regulatory compliance.

ADR (Adverse Drug Reaction)
An Adverse Drug Reaction (ADR) is a harmful and unintended response to a medicine that occurs at doses normally used for prevention, diagnosis or therapy. ADRs are a primary focus of pharmacovigilance and must be reported to regulatory authorities such as FDA, EMA and MHRA.
Black Triangle ▼
The Black Triangle symbol (▼) is placed on medicines that are under additional monitoring, typically because they are new to the market or have limited safety data. Healthcare professionals are especially encouraged to report any suspected adverse reactions for these products.
CIOMS (Council for International Organizations of Medical Sciences)
CIOMS is an international organisation established by WHO and UNESCO that provides guidance on drug safety reporting. The CIOMS I form is the standardised format used worldwide for expedited reporting of individual case safety reports (ICSRs) to regulatory agencies.
Dechallenge
Dechallenge refers to the withdrawal of a suspected medicine and the subsequent observation of whether the adverse reaction resolves. A positive dechallenge (where the reaction improves or disappears after stopping the drug) supports a causal relationship between the medicine and the adverse event in pharmacovigilance assessment.
EPAR (European Public Assessment Report)
An EPAR is a document published by the EMA for every medicine approved through the centralised procedure. It includes a summary of the scientific assessment, the benefit-risk evaluation, and conditions for use. EPARs are publicly available and provide transparency about regulatory decisions.
EudraVigilance
EudraVigilance is the European database for managing and analysing reports of suspected adverse reactions to medicines authorised in the European Economic Area (EEA). Maintained by the EMA, it is a key tool for signal detection and safety monitoring across the EU.
FAERS (FDA Adverse Event Reporting System)
FAERS is the U.S. database for spontaneous reports of adverse events and medication errors submitted to the FDA. It supports the FDA's post-marketing safety surveillance and is one of the largest pharmacovigilance databases in the world.
ICSR (Individual Case Safety Report)
An ICSR (Individual Case Safety Report) is a structured report documenting a suspected adverse drug reaction in a single patient. ICSRs are the primary data source in pharmacovigilance and are submitted to regulatory agencies such as FDA, EMA and MHRA to support ongoing drug safety monitoring. They follow the ICH E2B standard format.
MedDRA (Medical Dictionary for Regulatory Activities)
MedDRA is the standardised medical terminology used internationally for coding adverse events, medical conditions, indications, and investigations in regulatory activities. Developed by ICH, it ensures consistent communication between pharmaceutical companies, regulators, and clinical research organisations worldwide.
PRAC (Pharmacovigilance Risk Assessment Committee)
PRAC is the EMA committee responsible for assessing and monitoring the safety of human medicines. PRAC evaluates safety signals, reviews risk management plans (RMPs), and recommends regulatory actions such as label changes, restrictions, or withdrawals to protect public health across the European Union.
PSUR (Periodic Safety Update Report)
A PSUR (Periodic Safety Update Report) is a comprehensive pharmacovigilance document submitted by marketing authorisation holders at defined time intervals. It provides an updated analysis of the benefit-risk balance of a medicinal product, incorporating all available safety data worldwide. PSURs are required by EMA, FDA (as PBRERs), and other regulatory agencies.
Rechallenge
Rechallenge is the reintroduction of a suspected medicine after a dechallenge to determine whether the adverse reaction recurs. A positive rechallenge (where the reaction reappears) provides strong evidence of a causal relationship in ICSR causality assessment.
RMP (Risk Management Plan)
A Risk Management Plan (RMP) is a document that describes the safety profile of a medicine and the measures planned to prevent, minimise, or further study identified and potential risks. RMPs are required by the EMA for all new marketing authorisation applications and are updated throughout a product's lifecycle.
Safety Signal
A safety signal is new information on a possible causal relationship between a medicine and an adverse event that requires further investigation. Signals are detected through analysis of ICSR databases (such as EudraVigilance, FAERS, and VigiBase), clinical trials, and scientific literature. Signal detection is a core pharmacovigilance activity.
Signal Detection
Signal detection is the systematic process of identifying new safety concerns about medicines from pharmacovigilance data. It involves statistical screening of adverse event databases and is performed routinely by regulatory agencies and marketing authorisation holders to ensure ongoing drug safety.
SUSAR (Suspected Unexpected Serious Adverse Reaction)
A SUSAR is a serious adverse reaction that is not previously documented in the product's reference safety information (such as the Investigator's Brochure for clinical trials or the SmPC for marketed products). SUSARs require expedited reporting to regulatory authorities within strict timeframes.
VigiBase
VigiBase is the WHO global database of individual case safety reports (ICSRs). It is the world's largest pharmacovigilance database, containing reports from over 150 countries. Managed by the Uppsala Monitoring Centre, VigiBase is used for international signal detection and safety research.
VigiFlow
VigiFlow is the WHO web-based ICSR management system used by national pharmacovigilance centres worldwide. It enables the collection, management, and submission of adverse drug reaction reports to VigiBase, supporting global drug safety monitoring.

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