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Lifecycle of a Safety Signal
In pharmacovigilance, the identification of a potential safety signal is the beginning of a structured scientific and regulatory process—not the conclusion. A safety signal may arise from spontaneous…
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pharmacovigilance
40 articles
Gene and Cell Therapies Safety: A Pharmacovigilance Perspective
Gene and cell therapies are transforming modern medicine by offering treatments that target the underlying causes of disease rather than merely managing symptoms. These advanced therapy medicinal products…
Important FDA Issues Guidance to Improve Collection of Pregnancy Safety Data for Drugs and Biologics
U.S. Food and Drug Administration issued a final guidance for industry titled Postapproval Pregnancy Safety Studies on May 8, 2026. The guidance provides recommendations on methodologies that can…
From CCDS to SmPC: Why Global Safety Information Cannot Be Copied Directly into EU Product Information
For pharmaceutical companies operating globally, maintaining consistent and compliant product information is one of the most complex aspects of lifecycle management. The Company Core Data Sheet (CCDS) serves…
Important EMA Launches New Advisory Group on Vaccine Confidence
European Medicines Agency announced the establishment of a new advisory group on vaccine confidence to support the Agency’s efforts to address vaccine hesitancy and strengthen public trust in…
Warnings China Releases National Adverse Drug Reaction Monitoring Annual Report 2025
National Medical Products Administration,China NMPA and the National Center for Adverse Drug Reaction Monitoring released the National Adverse Drug Reaction Monitoring Annual Report (2025). The report was published…
Effectiveness of Risk Minimisation Measures: Designing Assessments That Regulators Can Trust
Every medicinal product carry benefits and risks. While many risks can be managed through routine measures such as product labelling and prescribing information, some require additional interventions to…
Modernizing Post-Approval Safety Data Management Under ICH E2D(R1)
The post-approval phase of a medicinal product’s lifecycle represents a critical period for continuous safety monitoring. As medicines are exposed to larger and more diverse patient populations, new…
Pharmacovigilance for Biosimilar Products: Navigating the Complexities of Traceability
The increasing availability of biosimilar medicinal products has transformed healthcare by expanding patient access to life-saving biological therapies while reducing treatment costs. Biosimilars are highly similar to an…
Effective Signal Management: Bridging Data Detection and Regulatory Action
In the evolving landscape of pharmacovigilance, signal management has become a central pillar in ensuring drug safety and maintaining compliance with global regulatory affairs requirements. It goes beyond…
Important EMA Introduces New PRIME Tools to Accelerate Medicine Development in the EU
The European Medicines Agency (EMA) has introduced three new features under its PRIME scheme to enhance the development of medicines targeting unmet medical needs. These tools aim to…
Ensuring Business Continuity in Pharmacovigilance Operations
Ensuring business continuity in pharmacovigilance operations is essential for safeguarding public health by continuously monitoring the safety of medicinal products. Any disruption in PV operations—whether due to system…
Trending topics Spain Reports Increase in Adverse Drug Reactions in 2025 Pharmacovigilance Annual Report
The Spanish Agency for Medicines and Health Products (AEMPS) has published the annual report of the Spanish Pharmacovigilance System for Medicines for Human Use (SEFV-H), highlighting key developments…
Integrating Real-World Data into Pharmacovigilance Systems
Pharmacovigilance (PV) has traditionally relied on spontaneous reporting systems, clinical trial data, and published literature to monitor the safety of medicinal products. However, the increasing availability of real-world…
Important FDA Launches New Adverse Event Monitoring System (AEMS)
The U.S. Food and Drug Administration announced on March 11, 2026, the launch of a new unified platform for analyzing adverse event reports. The system, known as the…
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