Applications of Blockchain Technology for Pharmaceutical Regulation, Supply Chain, and Pharmacovigilance: A Comprehensive Review

Abstract

This comprehensive assessment critically evaluates the growing importance of blockchain technology in the pharmaceutical industry, with particular emphasis on regulatory compliance, supply chain integrity, and pharmacovigilance systems. The paper describes blockchain's evolution from its origins in cryptocurrency to its contemporary applications in pharmaceutical manufacture, distribution, clinical research, patient data protection, and post-marketing surveillance. The main regulatory standards, such as the Drug Supply Chain Security Act (DSCSA), General Data Protection Regulation (GDPR), Health Insurance Portability and Accountability Act (HIPAA), and 21 CFR Part 11 (Code of Federal Regulations), are evaluated in terms of blockchain's ability to ensure compliance through immutable audit trails, smart contracts, and decentralised data management. Real-life examples of MediLedger, BRUINchain, and IBM Blockchain projects are provided to demonstrate how traceability, counterfeit prevention, transparency, regulatory preparation, and operational efficiency have been enhanced. The research also highlights blockchain's growing effects on clinical trial governance, informed consent management, adverse drug reaction reporting, and cross-border regulatory collaboration. Despite significant long-term benefits, such as improved security, reduced fraud, real-time verification, and cost savings, problems such as scalability, system integration, regulatory harmonisation, and data privacy remain significant barriers to wider adoption. Overall, blockchain is a new digital infrastructure that has the potential to strengthen pharmaceutical governance and improve patient safety on a global scale.