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Pharmacovigilance glossary

60 key drug safety terms explained in plain language, from adverse events and ICSRs to PBRERs, E2B (R3), MedDRA and SUSARs.

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A

Adverse drug reactionADR: A response to a medicinal product that is noxious and unintended. In EU legislation this includes reactions from use within and outside the terms of the marketing authorisation, including misuse, abuse and medication errors.
Adverse eventAE: Any untoward medical occurrence in a patient or clinical trial subject given a medicinal product, which does not necessarily have a causal relationship with the treatment.
Aggregate report: A periodic report that summarises and evaluates safety data for a product across a defined interval, such as a PSUR, PBRER, DSUR or PADER.
ALCOA+: Data integrity principles: data should be Attributable, Legible, Contemporaneous, Original and Accurate, plus Complete, Consistent, Enduring and Available.
ATC classificationAnatomical Therapeutic Chemical: The WHO system that classifies active substances by the organ or system they act on and by their therapeutic, pharmacological and chemical properties.
Audit trail: A secure, time-stamped record of who did what to a record, when, and what changed, allowing any decision to be reconstructed.

B

Benefit–risk evaluation: An assessment of whether the benefits of a medicinal product continue to outweigh its risks, central to periodic reports such as the PBRER.

C

CAPACorrective and preventive action: Actions taken to correct the cause of a deviation or quality problem and to prevent it from happening again.
Causality assessment: The evaluation of how likely it is that a medicinal product caused an adverse event, often using structured methods such as the WHO-UMC system.
CIOMSCouncil for International Organizations of Medical Sciences: An international organisation whose working groups publish widely used guidance on drug safety. The CIOMS I form is a standard format for reporting individual suspected adverse reactions.
Company Core Safety InformationCCSI: The safety information within a company’s core data sheet for a product, often used as the reference for listedness in periodic reports.

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21 CFR Part 11: US FDA regulation setting requirements for electronic records and electronic signatures, so they can be trusted as equivalent to paper records and handwritten signatures.

D

Data lock pointDLP: The cut-off date for data included in a periodic report.
Day zeroClock start: The date on which the marketing authorisation holder first becomes aware of a report that meets the minimum criteria for a valid ICSR. Reporting timelines run from this date.
Designated medical eventDME: A medical event considered serious and often drug-related, used to prioritise case review and signal detection.
Disproportionality analysis: Statistical methods that compare how often an event is reported with a product against how often it is reported with other products, used to detect potential signals. Examples include PRR, ROR and EBGM.
DSURDevelopment Safety Update Report: An annual report on the safety of a medicinal product under clinical development, described in ICH E2F.
Duplicate detection: The process of identifying when the same case has been reported more than once, from the same or different sources, so it is counted only once.

E

E2B (R3)ICH E2B (R3): The ICH standard for the electronic transmission of individual case safety reports, based on an XML message format, used by regulators including EMA and FDA.
E2C (R2)ICH E2C (R2): The ICH guideline describing the Periodic Benefit-Risk Evaluation Report (PBRER).
EBGMEmpirical Bayes Geometric Mean: A Bayesian disproportionality measure used in signal detection. Its lower confidence bound (EB05) is commonly used as a threshold.
EU Annex 11: The EU GMP annex that sets requirements for computerised systems used in regulated activities.
EudraVigilance: The European Medicines Agency’s system for managing and analysing information on suspected adverse reactions to medicines authorised in the European Economic Area.
EURD listEU reference dates: The EU list setting reference dates and submission frequencies for PSURs of active substances and combinations.
ExpectednessListedness: Whether an adverse reaction is consistent with the product’s reference safety information. An event not described there is unexpected (or unlisted).
Expedited reporting: Reporting of individual cases to regulators within short, fixed timelines, such as 15 calendar days for serious cases in the EU and for FDA 15-day alert reports.

F

FAERSFDA Adverse Event Reporting System: The US FDA database of adverse event and medication error reports submitted to the agency.
Follow-up information: Additional information received about a case after the initial report. Significant follow-up can restart the reporting clock.

G

GAMP 5: Industry guidance from ISPE for a risk-based approach to validating computerised systems used in regulated environments.
GVPGood Pharmacovigilance Practices: The EU guidelines, organised in modules, that describe how pharmacovigilance is carried out. Module VI covers ICSRs; Module VII covers PSURs; Module IX covers signal management.

I

ICHInternational Council for Harmonisation: The body that brings regulators and industry together to develop harmonised technical guidelines, including the E2 series on pharmacovigilance.
ICSRIndividual case safety report: A report of one or more suspected adverse reactions in a single patient, in a standard format. A valid ICSR needs four minimum criteria.
Important medical eventIME: An event that may not be immediately life-threatening or result in hospitalisation, but may jeopardise the patient or require intervention to prevent a serious outcome. EMA publishes an IME list.

L

Literature monitoring: The systematic screening of published medical literature for reports of suspected adverse reactions, a legal obligation for marketing authorisation holders.

M

Marketing authorisation holderMAH: The company that holds the authorisation to market a medicinal product and is responsible for its pharmacovigilance.
MedDRAMedical Dictionary for Regulatory Activities: The ICH medical terminology used to code adverse events, indications and medical history. Its hierarchy runs from system organ class (SOC) through HLGT, HLT and preferred term (PT) to lowest level term (LLT). New versions are released twice a year.
MedWatchFDA forms 3500 and 3500A: The FDA safety information and adverse event reporting programme. Form 3500 is for voluntary reports; form 3500A is for mandatory reports from manufacturers and others.
Minimum criteriaValid ICSR: The four elements a report needs to be a valid ICSR: an identifiable reporter, an identifiable patient, at least one suspect product and at least one adverse reaction.

N

Neurosymbolic AI: AI that combines neural methods, which understand language and documents, with symbolic methods, which reason over rules and knowledge, so results can be checked and explained.

P

PADERPeriodic Adverse Drug Experience Report: A US periodic report of adverse drug experiences, submitted quarterly for the first three years after approval and annually after that.
PBRERPeriodic Benefit-Risk Evaluation Report: A periodic report, described in ICH E2C (R2), that evaluates the benefit–risk balance of a product. In the EU it is the format used for PSURs.
PharmacovigilancePV: The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.
PRRProportional reporting ratio: A disproportionality measure comparing the proportion of reports of an event for one product with the same proportion for all other products.
PSMFPharmacovigilance System Master File: A detailed description of the pharmacovigilance system used by a marketing authorisation holder in the EU.
PSURPeriodic Safety Update Report: A periodic report evaluating the benefit–risk balance of a medicinal product after authorisation. In the EU it follows the PBRER format.

Q

QPPVQualified Person Responsible for Pharmacovigilance: The individual in the EU responsible for establishing and maintaining a marketing authorisation holder’s pharmacovigilance system.

R

Reference safety informationRSI: The product information used to judge whether an adverse reaction is expected, such as the CCSI or the investigator’s brochure.
REMSRisk Evaluation and Mitigation Strategy: A US FDA programme of safety measures required for certain medicines with serious safety concerns.
Risk management planRMP: A document describing a product’s safety profile and how its risks will be monitored, minimised and communicated.
RORReporting odds ratio: A disproportionality measure based on the odds of an event being reported with a product compared with all other products.

S

SDEASafety data exchange agreement: A contract between companies that sets out how and when safety information is exchanged between them.
Serious adverse eventSAE: An event that results in death, is life-threatening, requires or prolongs hospitalisation, results in persistent or significant disability, is a congenital anomaly, or is otherwise medically important.
Seriousness vs severity: Seriousness is a regulatory classification based on outcome. Severity describes intensity (mild, moderate, severe). A severe headache is not necessarily serious.
Signal: Information from one or more sources suggesting a new potentially causal association, or a new aspect of a known association, between an intervention and an event, judged sufficient to justify further action.
Signal management: The process of detecting, validating, analysing, prioritising and assessing signals, and recommending action.
SMQStandardised MedDRA Query: A validated grouping of MedDRA terms relating to a defined medical condition, used for searching and signal detection.
Spontaneous report: An unsolicited report from a healthcare professional or consumer describing a suspected adverse reaction, not derived from a study.
SUSARSuspected unexpected serious adverse reaction: A serious adverse reaction in a clinical trial that is not consistent with the reference safety information. Fatal or life-threatening SUSARs are reported within 7 days; others within 15 days.

W

WHODrugWHO Drug Global: The international dictionary of medicinal product information maintained by the Uppsala Monitoring Centre, used to code suspect and concomitant medicines.

Z

Zero-touch processing: Processing of eligible cases from intake to submission and acknowledgement with no manual step, under eligibility rules agreed and validated with the client.

Definitions are simplified summaries for general understanding. Always refer to the current regulations and guidelines for formal requirements.

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Pharmacovigilance glossary

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Intelligent safety should be one connected operation

6-week pilot on literature monitoring