A Review: Pharmacovigilance and Studies of Clinical Research for Health Care

Abstract

Pharmacovigilance (PV) plays a critical role in ensuring drug safety by monitoring, detecting, assessing, and preventing adverse drug reactions (ADRs) and other medication-related risks. This review explores the evolution of pharmacovigilance, from its historical foundations to modern advancements in artificial intelligence, big data analytics, and real-world evidence (RWE). Key topics include global regulatory frameworks (e.g., WHO, ICH, FDA, EMA), methodologies for signal detection, risk management plans (RMPs), and the growing importance of patient-reported outcomes. Challenges such as underreporting, data quality, and globalization of drug markets are discussed, alongside emerging trends like digital pharmacovigilance and vaccine safety surveillance. The article underscores the need for robust PV systems to enhance public health and foster trust in therapeutic interventions.

Introduction

Pharmacovigilance (PV) is the science and activities focused on detecting, assessing, understanding, and preventing adverse effects or other drug-related problems. It ensures drug safety throughout a medicine’s lifecycle, from clinical trials to post-marketing.

Key Aspects of Pharmacovigilance

• Identification of unknown adverse drug reactions (ADRs).

• Evaluation of risks vs. benefits.

• Prevention of harm via regulatory actions.

• Risk communication to healthcare providers and patients.

• Promotion of rational and safe drug use.

Importance

• Protects patient safety.

• Ensures public health.

• Supports regulatory compliance.

• Enables continuous monitoring, capturing long-term side effects.

Pharmacovigilance Process

• Data collection from multiple sources.

• Signal detection and risk assessment.

• Risk management through plans and communication.

History

• Began after the 1960s thalidomide tragedy.

• WHO established global PV programs.

• National PV systems and international guidelines developed.

• Modern PV uses AI, big data, and social media for better monitoring.

Objectives

• Detect ADRs.

• Assess drug safety and benefits.

• Prevent harm with regulatory measures.

• Improve patient safety and public health.

• Promote rational medicine use.

• Support regulatory decisions.

Scope

• Covers pre-marketing (clinical trials) and post-marketing surveillance.

• Risk management and signal detection.

• Focus on special populations and alternative medicines.

• Vaccine safety monitoring.

ADR Monitoring Centers in India

• Over 250 centers including AIIMS, PGIMER, JIPMER, CMC, and others.

Types of Pharmacovigilance

• Passive (voluntary reporting) and active (systematic surveillance).

• Pre-marketing and post-marketing phases.

• Various study methodologies like spontaneous reports, cohort studies, AI analysis.

• Specialized PV for vaccines, oncology, pediatrics, and herbal medicines.

• Regulatory-led and industry-led PV.

Clinical Research & Trials

• Phases 0-IV progressively test safety, dosage, efficacy, and long-term effects.

• Phase IV monitors post-marketing safety.

Regulatory Bodies in India

• CDSCO: Oversees drug approvals, licensing, quality control, and PV.

• DCGI: Head of CDSCO, approves new drugs and clinical trials, regulates biologics and vaccines, and enforces bans.

ANDA (Abbreviated New Drug Application)

• For generic drug approval in the U.S.

• Requires bioequivalence data, no full clinical trials.

• Enables cheaper, faster generic entry.

NDA (New Drug Application)

• Comprehensive submission for new drug approval.

• Requires full preclinical and clinical trial data.

• Types include standard, priority review, and breakthrough therapy NDAs.

• Reviewed thoroughly by regulatory authorities.

Conclusion

Pharmacovigilance (PV) plays a critical role in ensuring drug safety by monitoring, detecting, assessing, and preventing adverse drug reactions (ADRs) and other medication-related risks. Through robust systems like VigiFlow, EudraVigilance, and PvPI (India), PV bridges the gap between clinical trials and real-world drug use, uncovering rare or long-term side effects that may not be evident during pre-marketing studies. The evolution of pharmacovigilance—from spontaneous reporting to AI-driven signal detection—has significantly enhanced drug safety surveillance. However, challenges such as underreporting, data heterogeneity, and globalization of drug supply chains persist. Strengthening digital tools, global collaboration, and patient engagement will be key to advancing PV systems.

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Copyright

Copyright © 2025 Mr. Narendra Kaluram Choudhari, Ms. Aishwarya Todkar, Mr. Nitin Gawai. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.