Regulatory Terminologies
Regulatory terminologies refer to specific terms and phrases used in the context of
regulations, compliance, and legal frameworks across various industries, such as finance,
healthcare, pharmaceuticals, and environmental management. These terminologies are
important for understanding and adhering to laws, guidelines, and standards set by
government bodies or regulatory agencies. Here are some common regulatory terms:
Clinical trial
A systematic study on pharmaceutical products in human subjects (including patients and
other volunteers) in order to discover or verify the effects of and/or identify any adverse
reaction to investigational products, and/or to study the absorption, distribution,
metabolism and excretion of the products with the objective of ascertaining their efficacy
and safety.
Cohort Event Monitoring
Cohort Event Monitoring (CEM) is a prospective, observational study of events that occur
during the use of medicines, for intensified follow-up of selected medicinal products phase.
Patients are monitored from the time they begin treatment, and for a defined period of time.
Compliance
Compliance means faithful adherence by the patient to the prescriber's instructions.
Critical terms
Some of the terms in WHO-ART are marked as 'Critical Terms'. These terms either refer to
or might be indicative of serious disease states, and warrant special attention, because of
their possible association with the risk of serious illness which may lead to more decisive
action than reports on other terms.
Data mining
A general term for computerized extraction of potentially interesting patterns from large
datasets, often based on statistical algorithms. A related term with essentially the same
meaning is 'pattern discovery'. In pharmacovigilance, the commonest application of data
mining is also called disproportionality analysis, for example using the Information
component (IC).
DE challenge
DE challenge refers to withdrawal of a drug from a patient; the point at which the
continuity, reduction or disappearance of adverse effects may be observed.
Epidemiology
The science concerned with the study of the factors determining and influencing the
frequency and distribution of disease, injury and other health-related events and their
causes in a defined human population for the purpose of establishing programs to prevent
and control their medicines development and spread (Dorland's Illustrated Medical
Dictionary).
Essential
Essential medicines are those that satisfy the priority healthcare needs of the population.
They are selected with due regard to public health relevance, evidence on efficacy and
safety, and comparative cost-effectiveness.
Generic (multisource product)
The term 'generic product has somewhat different meanings in different jurisdictions.
Generic products may be marketed either under the non-proprietary approved name or
under a new brand (proprietary) name. They are usually intended to be interchangeable
with the innovator product, which is usually manufactured without a license from the
innovator company and marketed after the expiry of patent or other exclusivity rights.
Herbal medicine
This includes herbs, herbal materials, herbal preparations and finished herbal products.
Homeopathy
Homeopathy is a therapeutic system which works on the principle that works on the
principle of 'like treats like'. This system claims to treat the ill, not the illness. An illness is
treated with a medicine which could produce different symptoms in another person. The
active ingredients are given in highly diluted form to avoid toxicity. Homeopathic remedies
are virtually 100% safe.
Information component (IC)
The Information component (IC) measures the disproportionality in the reporting of a drug-
ADR pair in an ICSR database, relative to the reporting expected based on the overall
reporting of the drug and the ADR. Positive IC values indicate higher reporting than
expected.
The IC has also been implemented on electronic health records, to detect interesting
temporal relationships between drug prescriptions and medical events.
Incidence
Incidence means the number of new cases of an outcome which develop over a defined
period in a defined population at risk.
Individual Case Safety Report (ICSR)
A report that contains information describing a suspected adverse drug reaction related to
the administration of one or more medicinal products to an individual patient...
MedDRA
MedDRA is the Medical Dictionary for Regulatory Activities. WHO-ART, the WHO Adverse
Reactions Terminology, is now mapped to MedDRA.
Medical error
Medical error means an unintended act (either of omission or commission) or one that does
not achieve its intended outcomes.
Member countries
Countries which comply with the criteria for, and have joined the WHO Programme for
International Drug Monitoring are considered as member countries.
National pharmacovigilance centers
Organizations recognized by governments to represent their country in the WHO.
Programme (usually the drug regulatory agency). A single, governmentally recognized
Centre (or integrated system) within a country with the clinical and scientific expertise to
collect, collate, analyze and provide the advices on all information related to drug safety.
OTC (Over the Counter) medicine
Medicinal product available to the public without prescription.
Pani-Flow
Software developed by UMC for collection and analysis of data in relation to vaccinations in
a pandemic situation.
Periodic Safety Update Report (PSUR)
A systematic review of the global safety data which became available to the manufacturer of
a marketed drug during a specific time period. Produced in an internationally agreed
format.
Pharmacovigilance
The science and activities relating to the detection, assessment, understanding and
prevention of adverse effects or any other drug related problem.
Polypharmacy
The concomitant use of more than one drug, sometimes prescribed by different
practitioners is called polypharmacy.
Predisposing factors
Any aspect of the patient's history (other than the drug) which might explain reported
adverse events (genetic factors, diet, alcohol consumption, disease history, polypharmacy,
or use of herbal medicines, for example).
Prescription Event Monitoring (PEM)
System created to monitor adverse drug events in a population. Prescribers are requested
to report all events, regardless of whether they are suspected adverse events, for identified
patients receiving a specified drug. Also more accurately named Cohort Event Monitoring.
Prescription Only Medicine (POM)
Medicinal product available to the public only on prescription is called Prescription Only
Medicine.
Prevalence
Prevalence means number of existing cases of an outcome in a defined population at a given
point in time.
Rational drug use
An ideal of therapeutic practice in which drugs are prescribed and used in exact accordance
with the best understanding of their appropriateness for the indication and the patient, and
of their benefit, harm effectiveness and risk.
Rechallenge
Rechallenge means the point at which a drug is again given to a patient after its previous
withdrawal.
Record linkage
Method of assembling information contained in two or more records, e.g. in different sets of
medical charts, and in vital records such as birth and death certificates. This makes it
possible to relate significant health events that are remote from one another in time and
place.
Reference risk
Risk in a population of unexposed persons; also called baseline risk. Reference risk can be
measured over time (incidence) or at a given time (prevalence). The unexposed population
refers to a reference population, as closely comparable to the exposed population as
possible, apart from the exposure.
Regulatory authority
This is the legal authority in any country with the responsibility of regulating all matters
relating to drugs.
Relative risk
Ratio of the risk in an exposed population (absolute risk) and the risk in an unexposed
population (reference risk). Relative risk is the result of a relative comparison between
outcome frequency measurements, e.g. incidences.
