The Challenge of Workforce Development and Post-Marketing Safety
Despite the rapid technological growth, Document 5 highlights the 2026 focus on Workforce Talent Gaps and Safety Surveillance.
The explosive demand for gene therapy manufacturing has outpaced the availability of trained professionals in Quality Control (QC) and GMP operations. In response, the South Korean government has launched national training initiatives for "Advanced Bio-Process Engineers." Simultaneously, South Korea has implemented one of the world's most stringent Post-Marketing Surveillance (PMS) frameworks for gene therapies. Every patient receiving a gene-modified product in 2026 is enrolled in a 15-year digital tracking system to monitor for delayed adverse events, ensuring that South Korea’s "fast-track" approvals do not compromise long-term public safety.