Pharmacovigilance and Regulatory Affairs

Pharmacovigilance in Accelerated Drug Approvals

Accelerated drug approval pathways, such as Fast Track, Breakthrough Therapy, and Conditional Approvals, enable timely access to life-saving treatments. However, these expedited processes often involve limited pre-market safety data, increasing the importance of robust pharmacovigilance mechanisms post-approval. Real-time surveillance, adaptive risk management, and active safety signal monitoring are critical to managing uncertainties around benefit-risk profiles. Innovative post-authorization safety studies (PASS), patient registries, and digital monitoring tools help close data gaps and inform risk mitigation strategies. Regulatory agencies demand proactive and transparent pharmacovigilance commitments from sponsors, including early signal detection, frequent reporting, and flexible response systems. Ensuring the safety of accelerated therapies requires a well-coordinated ecosystem of regulators, manufacturers, and healthcare professionals, underpinned by agile and resilient pharmacovigilance operations.