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Policy & strategy · 2017–2018

"Right to Try" Act & Regenerative Medicine

Regenerative medicine — cell, gene, and tissue-based therapies — promised new options for patients with serious or untreatable conditions, but realizing that promise required two things at once: a legal framework that could permit and regulate advanced therapeutics, and sustained research investment. In 2017–2018, Junghwan Park worked on this area at the Ministry of Health and Welfare, drafting an early roughly US$1 billion R&D plan and supporting legislative work for advanced therapies.

The policy period began by taking stock of a decade of public R&D. The Ministry reported support for 182 projects from 2008 to 2016, leading to two approved products, fourteen domestic and international clinical trials, and eleven technology transfers. That evidence informed work on a second-stage program: the task was to move from individual research successes toward a durable pipeline that could support promising science through clinical development and commercialization.

That groundwork became part of the foundation for what later grew into the Advanced Regenerative Bio Act (첨단재생의료 및 첨단바이오의약품 안전 및 지원에 관한 법률) — the law that, in force since 2020, governs the safety and support of advanced regenerative medical treatment and advanced biopharmaceuticals, including the conditions under which regenerative-medicine clinical research and treatment may proceed. The Act is the realized version of the framework that the earlier policy work pointed toward; it was carried to enactment and implementation by many people over the years that followed.

The field's institutional scaffolding grew alongside the law. The Regenerative Medicine Advancement Foundation (재생의료진흥재단) now runs both the support programs that make advanced regenerative-medicine clinical research workable in practice — managing R&D funding and full-cycle oversight for approved clinical research and helping translate results toward commercialization — and the policy work around it: researching and planning sector policy, supporting strategy, coordinating among agencies, and maintaining a data bank on the field. The early R&D plan and legislative groundwork are part of the lineage this research-support and policy apparatus descends from.

The significance is in the pairing that opens any new therapeutic field: regulatory enablement plus research investment. Park's contribution belongs to the early, foundational stretch of that arc — setting direction and laying groundwork — rather than to the full build-out, which spanned years and many contributors. Seen that way, this entry marks where Korea's now-substantial regenerative-medicine framework began to take shape.

Act ↗ R&D results and next phase ↗ RMAF — research ↗ RMAF — policy ↗

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