What is the Origin of Good Pharmacovigilance Practice?

The concept of 'pharmacovigilance' itself stems from the Greek 'pharmakon' (drug) and the Latin 'vigilare' (to keep watch), emphasizing the ongoing need for drug safety surveillance. GVP guidelines were formalized by international regulatory bodies, such as the European Medicines Agency (EMA), in response to historical drug safety crises, establishing a standardized global framework for risk management. This practice is foundational to modern clinical governance and patient care.

What is the Mechanism of Good Pharmacovigilance Practice?

GVP implementation involves establishing robust systems for adverse event reporting from healthcare professionals and patients, signal detection through database analysis, and periodic safety update reporting to regulatory authorities. This practice facilitates the continuous evaluation of the benefit-risk balance of a product. The outcome of GVP activities can lead to changes in prescribing information, product labeling, or, in severe cases, withdrawal of the drug from the market to ensure patient well-being.

Good Pharmacovigilance Practice

Meaning

Good Pharmacovigilance Practice (GVP) represents a comprehensive set of standards, procedures, and guidelines established to ensure the continuous, systematic monitoring of the safety profile of medicinal products throughout their lifecycle. GVP mandates the rigorous collection, detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. Adherence to GVP is a legal and ethical requirement for pharmaceutical companies and regulatory bodies to protect patient safety in clinical practice.

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

China's pharmacovigilance aligns with global ICH standards while retaining unique domestic requirements for a comprehensive safety system.

∞ Traditional Chinese Medicine (TCM)
∞ Good Pharmacovigilance Practice (GVP)
∞ Marketing Authorization Holder

HRTioAugust 3, 2025

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What Role Does Post-Market Surveillance Play in Long-Term Peptide Safety?

Post-market surveillance provides continuous, real-world data to safeguard long-term peptide therapy and refine personalized wellness protocols.

∞ Drug Safety
∞ Long-Term Safety
∞ Regulatory Science

HRTioAugust 24, 2025

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Do NMPA’s Post-Market Surveillance Standards for Hormones Match International Practices?

NMPA's post-market surveillance for hormones increasingly aligns with international GVP, emphasizing continuous safety evaluation and global data integration.

∞ Personalized Wellness
∞ Hypothalamic-Pituitary-Gonadal Axis
∞ Hormonal Optimization

HRTioJuly 25, 2025

Good Pharmacovigilance Practice

Meaning

Origin

Mechanism

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

What Role Does Post-Market Surveillance Play in Long-Term Peptide Safety?

Do NMPA’s Post-Market Surveillance Standards for Hormones Match International Practices?

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