Regulatory Requirements for Vaccine Development and Approval
DOI:
https://doi.org/10.48047/Keywords:
Vaccine regulation, regulatory harmonization, clinical development, manufacturing standards, pharmacovigilance.Abstract
This thesis presents a comprehensive analysis of regulatory requirements governing vaccine development and approval across major global jurisdictions including the United States Food and Drug Administration, European Medicines Agency, and World Health Organization prequalification pathway. Through systematic literature review of 487 documents, comparative regulatory analysis, three detailed case studies, and interviews with twenty-three expert stakeholders, the research examined preclinical requirements, clinical development standards, manufacturing and quality control expectations, accelerated approval pathways, and post-market surveillance systems
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References
World Health Organization. WHO TRS1039 Evaluation of the Quality, Safety and Efficacy of Messenger RNA Vaccines for the Prevention of Infectious Diseases: Regulatory Considerations; World Health Organization: Geneva, Switzerland, 2024.
European Medicines Agency. EMA’s Guideline on Data Requirements for Vaccine Platform Technology Master Files (vPTMF) for Veterinarians; European Medicines Agency: Amsterdam, The Netherlands, 2024
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