Question 1

What is the Meaning of Pharmacovigilance System?

Accepted Answer

A Pharmacovigilance System is the comprehensive, global set of processes and activities dedicated to the detection, assessment, understanding, and ultimately the prevention of adverse effects or any other problems related to pharmaceutical products. This systematic approach mandates the continuous monitoring of a medication's safety profile throughout its entire life cycle, beginning in clinical development and extending through its post-market use by the general public. The system represents a critical public health function, ensuring that the benefits of a medication continue to outweigh its risks in the real-world population. For hormonal therapies, this system meticulously tracks any unexpected endocrine, metabolic, or psychological side effects.

Question 2

What is the Origin of Pharmacovigilance System?

Accepted Answer

The formal discipline of pharmacovigilance was established globally following major drug safety crises, such as the thalidomide disaster in the 1960s, which tragically underscored the catastrophic consequences of inadequate post-market surveillance. Regulatory bodies worldwide subsequently mandated systematic reporting and rigorous analysis of adverse drug reactions (ADRs). The term is a compound of pharmakon (Greek for drug) and vigilantia (Latin for watchfulness), reflecting its core function.

Question 3

What is the Mechanism of Pharmacovigilance System?

Accepted Answer

The core mechanism involves the systematic collection and analysis of safety data from diverse sources, including spontaneous case reports from healthcare professionals and consumers, mandatory clinical trial data, and large-scale epidemiological studies. This data is entered into centralized databases where advanced signal detection algorithms are used to identify potential new safety risks or changes in the frequency of known risks. This continuous, iterative process allows regulatory agencies to issue safety warnings, update product labeling, or, in rare cases, necessitate a product's withdrawal from the market, ensuring the ongoing safety of therapeutic interventions.

Pharmacovigilance System

Meaning

Origin

Mechanism

How Do Chinese Pharmacovigilance Standards Compare with International Drug Safety Guidelines?

How Do Chinese Regulations Monitor the Long-Term Safety of Hormone Therapies?

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