What Is pharmacovigilance?
Increasing complexity in drug safety monitoring
Technology and innovation in 2025
Regulatory and industry trends
Looking forward: Challenges and opportunities
Ensuring the safety of medications doesn't end once they’re approved—it’s an ongoing process that requires careful, continuous monitoring. While clinical trials provide critical data on efficacy and short-term safety, they often can't capture the full spectrum of risks that may emerge once a drug is widely used in the general population.
In 2004, the withdrawal of Vioxx (rofecoxib), a nonsteroidal anti-inflammatory drug manufactured by Merck and widely prescribed for managing arthritis pain, revealed a critical vulnerability in the post-market drug safety surveillance system. A three-year randomized trial showed that patients using rofecoxib experienced twice the risk of cardiovascular events compared to those receiving placebo, prompting a global recall.1
Such episodes underscore the need for drug safety monitoring to extend beyond the approval phase. With the current wave of accelerated drug approvals, gene therapies, and personalized treatments, the need for robust pharmacovigilance is more urgent than ever.
Image Credit: Gumpanat/Shutterstock.com
What is pharmacovigilance?
Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or other drug-related problems.2
Traditionally, this involved passive surveillance, where healthcare providers or patients spontaneously reported adverse events. Although valuable, passive systems often suffer from underreporting and incomplete data.
To address these limitations, active surveillance models, such as those of the United States (U.S.) Food and Drug Administration (FDA)’s Sentinel Initiative has emerged. These systems proactively monitor real-world data, including electronic health records, insurance claims data, and registries, to detect safety signals and estimate drug-associated risks.3
What Happens When Drugs Fail Post-Approval?
Increasing complexity in drug safety monitoring
Several interrelated trends will drive the complexity of pharmacovigilance in 2025. The global expansion of clinical trials, the integration of heterogeneous patient populations, and the proliferation of biologics (medications in the form of proteins or genes from living organisms) and gene therapies all contribute to more diverse and unpredictable safety signals.4
Gene therapies pose unique safety challenges, with serious risks such as hepatotoxicity and insertional mutagenesis, and require constant and evolving pharmacovigilance strategies. For instance, the adeno-associated virus-based onasemnogene abeparvovec, which was the gene replacement therapy used for spinal muscular atrophy, led to fatal liver failure cases post-approval, prompting the European Medicines Agency (EMA) to strengthen liver monitoring guidelines.5
Moreover, the regulatory landscape after the coronavirus disease 2019 (COVID-19) pandemic has facilitated emergency use authorizations and conditional approvals, often based on limited pre-market safety data.
These trends have escalated the need for robust, real-time post-marketing surveillance systems capable of identifying adverse events that were undetectable in traditional clinical trials.4,6
What is Pharmacovigilance?
Technology and innovation in 2025
Emerging technologies are transforming pharmacovigilance into a dynamic, data-driven field. Artificial intelligence (AI) and machine learning are increasingly being employed for signal detection, causality assessment, and prediction of adverse drug reactions.4
These tools can analyze vast and diverse datasets from wearable devices, mobile health apps, and electronic health records, offering real-time safety insights.6,7
Modern pharmacovigilance integrates both passive and proactive approaches to monitor medical product safety. Reporting systems such as the European Medicines Agency (EMA)’s EudraVigilance and the FDA’s Adverse Event Reporting System (FAERS) and Vaccine Adverse Event Reporting System (VAERS) enable the documentation of suspected adverse drug reactions.8
Complementing these are structured frameworks such as Risk Evaluation and Mitigation Strategies (REMS), designed to manage the safety profiles of therapeutics with elevated risk.9
In recent years, electronic health records and health insurance data have become valuable for detecting emerging safety concerns through active monitoring.10 Regulatory bodies are also stressing the need for post-authorization research to assess long-term treatment outcomes and address uncertainties.
Additionally, advances in digital health, such as connected wearables, symptom-tracking apps, and user-reported experiences, are enhancing real-time data collection. These tools provide deeper insights into patient safety, allowing earlier identification of potential drug-related adverse reactions.10
The importance of pharmacovigilance tools has been emphasized by the growing number of studies that have utilized data from FAERS and EudraVigilance to assess the real-world safety of the numerous COVID-19 vaccines that emerged in the wake of the pandemic.11
The adverse reactions associated with immune checkpoint inhibitors are also being extensively investigated using FAERS and other similar platforms in Europe.12
Regulatory Trends in Pharma Manufacturing: Key Changes to Watch in 2025
Regulatory and industry trends
In addition to surveillance technologies, regulatory agencies worldwide are redefining pharmacovigilance frameworks to reflect these scientific and technological advancements.
The FDA’s Sentinel Initiative is a prime example of this shift. The initiative was launched in 2008, and in just over a decade, it has advanced into a comprehensive national electronic system that enables active surveillance using distributed data networks.
Sentinel's capabilities were strongly demonstrated during the COVID-19 pandemic when it was used to monitor vaccine safety in near real-time across millions of individuals.3
The FDA’s Sentinel Initiative has also expanded its scope through the Sentinel Innovation Center and the Active Risk Identification and Analysis (ARIA) system, which uses structured data to evaluate safety outcomes without needing new studies.3
In parallel, the World Health Organization’s VigiBase, the largest global database of individual case safety reports, is leveraging digital tools for signal detection and international coordination.
VigiBase, managed by the Uppsala Monitoring Centre, collects reports from over 130 countries and integrates sophisticated data mining techniques for early identification of safety concerns.13
Additionally, the WHO’s Global Benchmarking Tool stresses the importance of national systems adopting integrated surveillance methods, ensuring that emerging risks are captured across regions.2
The EMA has similarly emphasized the use of real-world evidence in post-market monitoring, especially for advanced therapies and vaccines. In 2022, the EMA updated its good pharmacovigilance practices to include digital methodologies and transparency in safety evaluations.4
The CDMO Surge: Why Pharma Is Outsourcing More Than Ever
Looking forward: Challenges and opportunities
Despite these advancements, several challenges persist in the field of pharmacovigilance. Integration of disparate data sources, sharing of data and operations between national surveillance systems, and data privacy concerns remain barriers to fully realizing global pharmacovigilance potential.6,8
Furthermore, the growing use and reliance on AI raises questions about algorithmic transparency, bias, and validation. Nonetheless, the convergence of digital technologies, international collaboration, and regulatory innovation presents an unprecedented opportunity.
As precision medicine and cell-based therapies gain traction, pharmacovigilance systems must adapt to monitor dynamic patient profiles and complex biological mechanisms.
In 2025, pharmacovigilance stands at a pivotal juncture. As therapies become more individualized and regulatory pathways accelerate, safeguarding patient safety demands a transition from passive reporting to proactive, real-time surveillance.
The FDA’s Sentinel Initiative and global platforms such as WHO’s VigiBase exemplify how integrated, data-driven, and collaborative approaches can meet the evolving demands of drug safety monitoring.
Additionally, the push toward patient-centricity, where patients are engaged as data contributors and safety partners, represents a paradigm shift in pharmacovigilance.
Such participatory and active efforts not only enrich data quality but also build public trust.
Strengthening these systems, embracing innovation, and harmonizing global regulatory frameworks will be crucial to ensuring that the benefits of new therapies are realized without compromising patient safety.
References
- Sibbald, B. (2004). Rofecoxib (Vioxx) voluntarily withdrawn from market. Canadian Medical Association Journal, 171(9), 1027–1028. DOI:10.1503/cmaj.1041606
- World Health Organization. (2025). Tools and Innovations in Pharmacovigilance. Retrieved April 6, 2025, from https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/guidance/operations/tools-innovations
- U.S. FDA. (2024, August 3). FDA’s Sentinel Initiative. Retrieved April 6, 2025, from https://www.fda.gov/safety/fdas-sentinel-initiative
- Trifirò, G., & Crisafulli, S. (2022). A New Era of Pharmacovigilance: Future Challenges and Opportunities. Frontiers in Drug Safety and Regulation, 2:866898. DOI:10.3389/fdsfr.2022.866898
- Petitpain, N., Antoine, M. L., Beurrier, M., Micallef, J., & Fresse, A. (2023). Pharmacovigilance of gene therapy medicinal products. Rare Disease and Orphan Drugs Journal, 2(4), -25. DOI:10.20517/rdodj.2023.19
- Dang, A. (2023). Real-World Evidence: A Primer. Pharmaceutical Medicine, 37(1), 25–36. DOI:10.1007/s40290-022-00456-6
- Dsouza, V. S., Leyens, L., Kurian, J. R., Brand, A., & Brand, H. (2025). Artificial intelligence (AI) in pharmacovigilance: A systematic review on predicting adverse drug reactions (ADR) in hospitalized patients. Research in Social and Administrative Pharmacy, 21(6). DOI:10.1016/j.sapharm.2025.02.008
- Sharrar, R. G., & Dieck, G. S. (2013). Monitoring product safety in the postmarketing environment. Therapeutic Advances in Drug Safety, 4(5), 211–219. DOI:10.1177/2042098613490780
- U.S. FDA. (2023). Risk Evaluation and Mitigation Strategies (REMS). U.S. Food and Drug Administration. Retrieved April 2, 2025, from https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems
- U.S. FDA. (2023). Postmarket surveillance with a novel mHealth platform. U.S. Food and Drug Administration. Retrieved April 2, 2025, from https://www.fda.gov/science-research/advancing-regulatory-science/postmarket-surveillance-novel-mhealth-platform
- Ferreira-da-Silva, R., Lobo, M. F., Pereira, A. M., Morato, M., Polónia, J. J., & Ribeiro-Vaz, I. (2025). Network analysis of adverse event patterns following immunization with mRNA COVID-19 vaccines: real-world data from the European pharmacovigilance database EudraVigilance. Frontiers in Medicine, 12, 1501921. DOI:10.3389/fmed.2025.1501921
- Köylü, B., Esen, B.H., Bektaş, Ş.N. et al. Pharmacovigilance analysis of immune checkpoint inhibitor-related reproductive adverse effects based on the FDA adverse event reporting system. Scientific Reports 15, 7770 (2025). DOI:10.1038/s41598-025-91476-0
- Uppsala Monitoring Centre. (n.d.). About VigiBase. Who-Umc.org. Retrieved April 6, 2025, from https://who-umc.org/vigibase/
Further Reading