2018 “Special Regulation” (特管辦法): Establishing a “controlled opening” clinical framework through subordinate regulations, and gradually moving toward dedicated legislation

Thai-Yen Ling, Ph.D.
Associate Professor, Department and Graduate Institute of Pharmacology
College of Medicine, National Taiwan University, Taipei, Taiwan

Taiwan’s dual regenerative medicine laws were officially implemented on January 1, 2026. Looking back at Taiwan’s legislative journey in regenerative medicine, the amended “Regulations Governing the Implementation or Use of Specific Medical Techniques, Examinations, Tests, and Medical Instruments” commonly known as the “Special Regulation” (特管辦法), formally announced by the Ministry of Health and Welfare (MOHW) on September 6, 2018, was a pivotal starting milestone. When confronted with patients’ urgent needs, where “time is life,” waiting solely for the completion of primary legislation was clearly too slow to meet the moment.

Against this backdrop, the then Director General of the Department of Medical Affairs, Minister Chung Liang Shih, proposed an innovative approach after careful deliberation. He used the Special Regulation, originally issued in 2003 with only 11 articles, as a regulatory foothold and established a manageable clinical governance framework through substantial amendments.

On September 6, 2018, the MOHW officially promulgated a comprehensively revised Special Regulation, expanded to 34 articles. Appendix Table 3 specifies six cell therapy items permitted for clinical use, with an initial focus on autologous cells, based on their higher safety and more predictable efficacy.

At the same time, the regulation broadened cancer indications beyond end-stage solid tumors to include patients with stage I to stage III disease who had failed standard treatments, as well as certain hematologic malignancies. This allowed cell therapy to enter clinical practice under a controllable regulatory framework. The policy message was clear. In the face of unmet medical needs, regulators may choose to open access, but the opening must be controlled. Speed can be pursued, but only on the premise of safety, quality, transparency, and traceability.

The “Stone Age”

2018 Special Regulation represented a ground-breaking leap in Taiwan’s healthcare governance and in the development of the biotech and medical sectors, particularly the cell therapy industry.

Minister Shih played an indispensable role in advancing this regulatory framework. This initiative not only benefited patients but also catalyzed rapid growth in Taiwan’s biotech and medical ecosystem, especially in cell therapy.

Because Minister Shih’s surname “石” corresponds to “stone” in English, people in the medical and biotech industries who are familiar with this history often use September 6, 2018, as a dividing line, calling the period before it “Before the Stone Age” and the period after it “The Stone Age.”

The term symbolizes the beginning of a new era in medicine and conveys respect and appreciation for Minister Shih’s contributions to building Taiwan’s regenerative medicine system.

From the Special Regulation to Taiwan’s Dual Regenerative Medicine Laws

As the number of cases accepted under the Special Regulation grew rapidly, governance tools also needed to be upgraded. In May 2022, the MOHW submitted draft bills for the dual regenerative medicine laws to the Executive Yuan for review. The institutional design focused on establishing dedicated funds, creating a national-level cell bank, and using mechanisms such as conditional approvals to shorten development timelines and accelerate market entry.

After multiple rounds of review at different stages, including 2018, 2023, and May 2024, the bills were finally passed on third reading by the Legislative Yuan on June 4, 2024. Going forward, new technologies and products involving “genes, cells, and their derivatives” for the treatment, repair, or replacement of human cells, tissues, and organs will be regulated under two separate legal instruments, the Regenerative Medicine Act and the Regenerative Medicinal Products Management Act. The goal is to provide new options for patients who respond poorly to existing treatments, while also driving domestic innovation and industrial development in regenerative medicine.

Taiwan’s Dual Regenerative Medicine Laws in 2026: Significance and Challenges

The implementation of the dual laws in 2026 is not merely an upgrade of the Special Regulation into higher-level legislation. More importantly, it expands the governance scope of regenerative medicine, moving from clinical pilot use, data accumulation, and risk control toward a complete closed loop that covers product development, scaled manufacturing, and market regulation.

Looking ahead, the real challenge lies not in the laws taking effect per se, but in whether the system can be implemented in a high-quality and sustainable manner. Key questions include whether real-world data generated after conditional approvals can be comprehensively collected and rigorously analyzed, whether long-term follow-up and adverse event reporting will be faithfully executed, whether review capacity and industry support can be strengthened in parallel, and whether National Health Insurance decisions can strike a transparent and consistent balance between cost effectiveness and equitable access.

2026 is not only the first year of implementation for Taiwan’s dual regenerative medicine laws, but also a key milestone in Taiwan’s transition from research to broader clinical adoption, and from isolated cases to an affordable and well regulated market. The term “The Stone Age” will become widely recognized and will be met with deep appreciation and gratitude.