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Adverse Drug Reaction Reporting Requirements
Q1. What is Pharmacovigilance?
Pharmacovigilance, as defined by the World Health Organization, is the science and activities relating to the detection, assessment, understanding and prevention of adverse events or any other possible drug-related problems. Recent inclusions to this definition are: herbals, traditional and complementary medicines, blood products, biologicals, medical devices and vaccines.
Q2. What is an adverse event (AE)?
An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does necessarily have to have a causal relationship with this treatment (ICH E2A).
Q3. What is an adverse reaction (AR)?
An adverse reaction is a noxious and unintended response to a marketed product that occurs at any dose used or tested for the diagnosis, treatment or prevention of a disease or for modifying an organic function.
Q4. What is an adverse drug reaction (ADR)?
It is a noxious response to a drug which is unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for modification of physiological function.
Q5. How does and AE differ from an AR?
An AR is characterized by the fact that a causal relationship between the drug and the event is suspected. This implies that there is a suspected relatedness to the administered drug.
Q6. What is a serious ADR or a serious adverse event?
A serious adverse event or adverse reaction is any untoward medical occurrence that at any dose:
·  Results in death
·  Is life-threatening                                                                
·  Requires in patient hospitalization or prolongation of existing hospitalization
·  Results in persistent or significant disability/incapacity or
·  Is a congenital anomaly or birth defect
Serious reactions/events must be reported to Pharmacovigilance Center within 24 hours
Q7. What are the minimum criteria for a valid ADR report?
The following minimum criteria must be met to make an ADR report valid:
·  Patient identifier e.g., initials, or age or date of birth or sex
·  Name of suspected medicinal product (s)
·  Details of the suspected reaction
·  An identifiable reporter (name, profession, institution, contact details)

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