Journal of Clinical Research and Pharmacy

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Mini Review - Journal of Clinical Research and Pharmacy (2025) Volume 8, Issue 3

Pharmacovigilance in the Era of Biologics and Biosimilars: Challenges and Solutions

Fatima Khan*

Department of Pharmacovigilance, Aga Khan University, Karachi, Pakistan

*Corresponding Author:
Fatima Khan
Department of Pharmacovigilance
Aga Khan University, Karachi, Pakistan.
E-mail: fatima.khan@aku.edu.pk

Received : 01-Aug-2025, Manuscript No. aajcrp-186; Editor assigned : 05-Aug-2025, PreQC No. aajcrp-186(PQ); Reviewed : 25-Aug-2025, QC No aajcrp-186; Revised : 03-Sep-2025, Manuscript No. aajcrp-186(R); Published : 12-Sep-2025 , DOI : 10.35841/aajcrp.7.2.186

Citation: Khan F. Pharmacovigilance transformed: Ai, rwd, proactive safety. aajcrp. 2025;08(03):186.

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Introduction

The field of pharmacovigilance is seeing profound changes, with Artificial Intelligence (AI) playing a key role. This article explores AI's application in pharmacovigilance, highlighting its current uses in adverse drug event detection, signal generation, and data analysis. It also discusses the implementation challenges, such as data quality and ethical considerations, and projects future directions for AI in enhancing drug safety and efficacy [1].

Practical guidance for utilizing Real-World Data (RWD) in pharmacovigilance, stemming from a multi-stakeholder initiative, is now available. This paper emphasizes RWD's potential to complement traditional safety data, improve signal detection, and offer more comprehensive insights into drug safety profiles in diverse patient populations. Challenges like data quality, access, and regulatory acceptance are also addressed [2].

Comparisons between pharmacovigilance systems in Europe and the United States reveal how regulatory bodies manage and mitigate drug safety risks in both regions. The article details differences and similarities in their approaches to adverse event reporting, signal detection, and risk management strategies, offering insights into best practices and areas for potential collaboration [3].

A concept of 'Proactive Pharmacovigilance' has been introduced, advocating for a shift from reactive monitoring to anticipatory risk management. This paper discusses strategies for early signal detection, integration of diverse data sources, and the use of advanced analytics to identify potential safety issues before they become widespread, thereby enhancing overall drug safety [4].

Modern pharmacovigilance approaches are being introduced, outlining key concepts, methods, and the evolving landscape of drug safety. This article addresses challenges such as managing increasing data volumes, incorporating real-world evidence, and leveraging new technologies to improve the detection and assessment of adverse drug reactions [5].

Global pharmacovigilance systems face current challenges and opportunities for improvement. One paper discusses the need for harmonization of regulations, enhanced international collaboration, and effective data sharing across diverse healthcare settings to ensure comprehensive monitoring of drug safety worldwide [6].

Social media's dual aspects in pharmacovigilance are also explored, recognizing both its potential and inherent challenges. This article discusses how platforms like Twitter and Facebook can serve as rich sources for detecting adverse drug reactions and generating safety signals, while highlighting concerns regarding data credibility, privacy, and the need for robust analytical tools [7].

The growing role of Artificial Intelligence (AI) in pharmacovigilance is reviewed, summarizing applications such as automated adverse event detection, text mining of unstructured data, and predictive modeling for drug safety. It highlights AI's capability to manage vast datasets and accelerate signal detection, while pointing out limitations and areas for future development [8].

Digital health technologies impact pharmacovigilance, presenting both challenges and opportunities. This article discusses how electronic health records, mobile health apps, and wearables can generate enormous amounts of data for safety monitoring, while also addressing the complexities of data integration, analysis, and ensuring data quality and privacy [9].

The evolving scope of pharmacovigilance is discussed, moving beyond traditional drug safety monitoring to encompass broader public health considerations. This paper highlights how pharmacovigilance now plays a crucial role in understanding drug effects in real-world settings, informing public health policies, and contributing to patient care and medication optimization [10].

 

Conclusion

Pharmacovigilance is undergoing significant transformation, embracing advanced technologies and diverse data sources to enhance drug safety. Artificial Intelligence (AI) is increasingly used for adverse drug event detection, signal generation, and data analysis, though challenges exist with data quality and ethical considerations. Real-world data (RWD) complements traditional safety information, offering comprehensive insights into drug safety in varied patient populations, despite concerns about data quality and regulatory acceptance. The field is shifting towards Proactive Pharmacovigilance, which emphasizes anticipatory risk management and early signal detection through integrated data and advanced analytics. Modern approaches address the complexities of increasing data volumes, incorporating real-world evidence, and leveraging new technologies for improved adverse drug reaction assessment. Social media also serves as a rich, albeit challenging, source for detecting adverse drug reactions, while digital health technologies like electronic health records and wearables generate vast amounts of data, presenting both opportunities and complexities in data integration, analysis, quality, and privacy. Globally, efforts focus on harmonizing regulations, fostering international collaboration, and effective data sharing to ensure comprehensive drug safety monitoring. The scope of pharmacovigilance expands beyond drug safety to encompass broader public health considerations, influencing policies and patient care in real-world settings. Regulatory bodies in regions like Europe and the United States continue to refine their approaches to mitigate drug safety risks, highlighting areas for potential collaboration.

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