FDA considers blockchain for secure drug application submissions

The U.S. Food and Drug Administration (FDA) is expected to spend about $2 billion in 2025 to review New Drug Applications (NDAs) and similar submissions. These applications are typically sent electronically in a format known as the electronic Common Technical Document (eCTD). The switch to electronic submissions has raised concerns about data integrity, as digital files can be altered. To ensure security, the FDA introduced strict regulations known as 21 CFR Part 11, which were designed to make electronic records as secure as paper records. However, the implementation of these regulations can be complicated and requires heavy auditing. There is now a growing push to use blockchain technology to improve this process. Blockchain is primarily known for its use in cryptocurrencies, but it also provides a secure, unchangeable record of information. Experts believe the FDA could use blockchain to enhance document authenticity without overhauling its existing systems. Instead of requiring full documents to be uploaded to the blockchain, a unique digital fingerprint, or checksum, of each document could be created and added to the blockchain. This would verify that documents remain unchanged, while keeping their content confidential. If the FDA allows blockchain solutions alongside current regulations, it could streamline the review process and reduce the need for extensive audits. This change could lead to faster and more efficient operations in drug applications. Beyond the FDA, blockchain technology is seen as having potential benefits for various sectors, including healthcare and supply chains. Business leaders are encouraged to consider how blockchain can improve data integrity and operational efficiency in their fields.