Question 1

What is the Meaning of VigiBase?

Accepted Answer

VigiBase is the World Health Organization's (WHO) global database of individual case safety reports (ICSRs), functioning as the most extensive international repository for suspected adverse drug reactions (ADRs). This critical pharmacovigilance tool allows for the continuous, real-world monitoring of the safety profile of all pharmaceutical products, including complex hormonal and metabolic medications, after they have been introduced to the market.

Question 2

What is the Origin of VigiBase?

Accepted Answer

The database was established in 1978 by the WHO Programme for International Drug Monitoring in response to the recognized need for a centralized system to detect rare or delayed adverse events not apparent in pre-market clinical trials. It represents a global collaborative effort to enhance patient safety through post-market surveillance.

Question 3

What is the Mechanism of VigiBase?

Accepted Answer

Healthcare providers and regulatory authorities submit ICSRs detailing suspected adverse events to their national centers, which subsequently forward the de-identified data to VigiBase. The Uppsala Monitoring Centre manages the database, utilizing sophisticated statistical and data mining algorithms to identify safety signals—potential causal associations between a drug, such as a new hormone analog, and an unexpected adverse reaction. This mechanism informs regulatory decisions and updates to clinical prescribing information worldwide.

VigiBase

Meaning

Origin

Mechanism

Can International Pharmacovigilance Data Influence NMPA’s Hormone Regulatory Decisions?

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