An Investigation into the Role of Regulatory Affairs in Accelerated Approval Pathways during Public Health Emergencies

Vollständiger Abstract

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This study set out to investigate the role of Regulatory Affairs (RA) in accelerated approval pathways during public health emergencies, with the following specific objectives: To examine and compare the structure of accelerated approval mechanisms across global regulatory agencies (FDA, EMA, WHO, CDSCO, PMDA, Health Canada). To analyze case studies of emergency authorizations — focusing on COVID-19 vaccines, antivirals (Remdesivir, Molnupiravir), and monoclonal antibody therapies. To evaluate the role of RA professionals in ensuring compliance, transparency, and patient safety during accelerated approvals. To explore key challenges, including public trust, reliance on limited clinical data, and global regulatory asymmetry. To propose policy recommendations for harmonized frameworks, digital technology integration, and capacity building in LMICs. COVID-19 Vaccines: Approvals were achieved in record time (