Pharmacovigilance Information

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The Concept of Pharmacovigilance

Before a new drug is authorised for sale to members of the public, it undergoes years of testing in both animals (pre-clinical) and human beings (clinical trials). These tests are done in order to understand how the drug will potentially work in humans and what adverse effects are likely to occur.

A drug marketing authorisation is granted following careful evaluation of clinical trial reports submitted to regulatory authorities. However, clinical trials have limited ability to reveal rare and long term adverse effects. Furthermore, patients selected for clinical trials are carefully screened and may not fully reflect the real-life population exposed to a given drug. 

Continuous monitoring for adverse effects, after the drug has been marketed and given to many more patients, is therefore important in order to reveal a fuller pattern of adverse effects. It is through pharmacovigilance activities that adverse drug effects are monitored on a continuous basis to ensure that patient safety is not compromised. To learn more about pharmacovigilance, please see below for some selected topics. 
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Pharmacovigilance Topics

Relevant topics are included in this section on a regular basis. If you require further information about any topic, please send an E-mail
stating your requirements.
Concept of Pharmacovigilance...more
FDA Pharmacovigilance Regulations...more
EU Pharmacovigilance Regulations & Directives...more
Defective Medicines & Recalls...more
Spontaneous Case Processing...more
The QPPV...more
Reference Safety Information...more