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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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signal detection
10 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 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…
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…
Impact of Manufacturing Changes on Pharmacovigilance Management
In the pharmaceutical industry, manufacturing processes are continuously evolving to improve product quality, optimize production efficiency, maintain supply continuity, and comply with evolving regulatory expectations. These modifications may…
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…
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…
PV Requirements in Singapore: A Practical Guide
Pharmacovigilance (PV) is a critical component of the global healthcare ecosystem, ensuring that medicines remain safe and effective after they are approved and introduced into the market. In…
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