Pharmacovigilance and Regulatory Affairs

Blockchain Applications in Regulatory Data Integrity

Blockchain technology offers a groundbreaking approach to enhancing transparency, security, and trust in regulatory and pharmacovigilance data. By providing a decentralized, immutable ledger of transactions, blockchain ensures that every data point whether related to adverse events, clinical trial results, or regulatory filings—is securely recorded, time-stamped, and traceable. This technology can significantly reduce data manipulation risks, facilitate faster audits, and improve regulatory compliance across the pharmaceutical value chain. In pharmacovigilance, blockchain enables real-time sharing of safety data among stakeholders, ensuring consistency and reducing duplication. It enhances the traceability of drug batches, linking adverse events with specific manufacturing lots or supply chains especially vital in biologics, vaccines, and personalized therapies.

Implementing blockchain also supports patient data ownership and consent tracking, ensuring ethical data usage. Despite its potential, challenges like interoperability, scalability, regulatory acceptance, and integration with legacy systems must be addressed. Continued collaboration between regulators, industry, and technology developers will be essential to unlocking blockchain’s full capabilities in ensuring data integrity and accountability in drug safety systems.