As of January 1, 2026, Taiwan's landmark Regenerative Medicine Act and the Regenerative Medicine Preparations Regulations will officially take effect. Minister of Health and Welfare Shih Chung-liang emphasized that strict advertising oversight will be a priority. He specifically addressed the current "exosome craze," noting that products ranging from oral supplements to topical creams—and even Japanese sake—are making exosome-related claims. "Be warned: starting next year, violations will face heavy penalties," Shih stated, urging the industry to exercise caution.

The "Twin Acts" passed their third reading in June 2024. Following the finalization of nine subsidiary laws and two fee schedules, the dual-track management system for regenerative technologies and preparations is ready for launch. Minister Shih noted that while regenerative medicine is visionary, it must develop steadily without "losing its way" early on. The new regulations aim to prevent "bad money from driving out good" and ensure that regenerative medicine maintains clinical integrity rather than appearing like "street-vendor medicine."

Key regulatory focus areas include:

• Full Lifecycle Management: From expedited market entry (including conditional approvals) to post-market safety surveillance.
• Stricter Advertising & Illegal Conduct Penalties: Fines for unauthorized or misleading claims will reach up to NT$20 million—the second-highest penalty tier in Taiwan, trailing only the Food Safety Act.
• Seamless Transition: Existing projects under the "Regulations Governing the Application of Specific Medical Technical Procedures" (Special Medical Act) will transition seamlessly without the need for immediate re-application until their current permits expire.

Resource: 外泌體之亂將終結？再生醫療雙法元旦上路 石崇良：注意會重罰