Are Regenerative Medicine and Stem Cells Legal in Taiwan? Key Points of the Two Regenerative Medicine Laws Effective January 1, 2026
Regenerative medicine and stem cell therapy are legal in Taiwan, but only when performed by medical institutions approved by the Ministry of Health and Welfare and within approved items and indications. The Regenerative Medicine Act and the Regenerative Medicine Preparations Act (together, the two regenerative medicine laws) were promulgated on June 19, 2024, and the Executive Yuan set their implementation from January 1, 2026, by Executive Yuan Order Tai-Wei-Zi No. 1141035478 dated December 30, 2025, establishing the definition, licensing, advertising management, and inspection framework for regenerative medicine. Before that, under the "Special Management Measures" that took effect in 2018, the Ministry of Health and Welfare opened specific autologous cell therapies, and approved institutions could perform them within the approved scope; after the two regenerative medicine laws took effect, subsidiary regulations such as the Regulations Governing Regenerative Medicine Technologies and Designated Preparations took effect on the same day. Taiwan's Food and Drug Administration (TFDA) is responsible for registration of regenerative medicine preparations; the Ministry of Health and Welfare is responsible for approving institutional qualifications. Verification channels: the Ministry of Health and Welfare's "Cell Therapy Technology Information Section" (celltherapy.mohw.gov.tw) and the Medical Affairs Management System (ma.mohw.gov.tw). This site provides neutral information only and does not constitute medical advice.
Key points of the two regenerative medicine laws (promulgated in 2024, effective in 2026)
Taiwan completed important regenerative medicine legislation in 2024, effective January 1, 2026, establishing a more complete management framework:
- The Regenerative Medicine Act and the Regenerative Medicine Preparations Act (the two regenerative medicine laws) were promulgated on June 19, 2024, and took effect on January 1, 2026.
- Regulate the definition of regenerative medicine, institutional licensing, advertising management, and inspection
- The Preparations Act establishes "conditional approval": for those completing Phase II clinical trials with confirmed safety and preliminary efficacy, a conditional time-limited approval of no more than 5 years may be granted
How to Confirm a Clinic's Legitimacy
Two official channels for cross-verification; if no approval is found, proceed with caution:
- Ministry of Health and Welfare's "Cell Therapy Technology Information Zone" (celltherapy.mohw.gov.tw): check approved institutions, technology types, and indications
- Ministry of Health and Welfare's Medical Affairs Management System (ma.mohw.gov.tw): check institution business registration
- If performing regenerative medicine, both the institution and the technology must be approved by the competent authority
Advertising and Consumer Protection
The Regenerative Medicine Act has clear regulations on promotion; exaggerated ads can be verified and reported:
- False or exaggerated claims (e.g., claiming "no side effects" without approval) are prohibited; violations may be penalized by law
- When encountering regenerative medicine ads, cross-check with Ministry of Health and Welfare's approved information
- Suspicious false claims can be reported to local health bureaus
FAQ
What is the regulatory framework for regenerative medicine in Taiwan? What changed in 2024?
Taiwan's main regulatory framework includes: ① the Regenerative Medicine Act (promulgated June 19, 2024, effective January 1, 2026): regulates the definition of regenerative medicine, institutional licensing, advertising management, and inspections; ② the Regenerative Medicine Preparations Act (promulgated and effective on the same dates): registration and post-market monitoring of regenerative medicine preparations; ③ the "Special Management Measures" (effective since 2018): specific autologous cell therapies are subject to an approval and licensing system; after the two regenerative medicine laws took effect, subsidiary regulations such as the Regulations Governing Regenerative Medicine Technologies and Designated Preparations took effect on the same day. TFDA is responsible for preparation registration, and the Ministry of Health and Welfare is responsible for approving institutional qualifications to perform treatments (sources: Laws and Regulations Database, Ministry of Health and Welfare).
How to confirm whether a clinic's regenerative medicine is legally approved?
There are two main official channels for verification: ① Ministry of Health and Welfare's "Cell Therapy Technology Information Zone" (celltherapy.mohw.gov.tw): lists approved institutions, technology types, and indications; ② Ministry of Health and Welfare's Medical Affairs Management System (ma.mohw.gov.tw): check the business registration of medical institutions. If performing regenerative medicine regulated by the Regenerative Medicine Act, both the institution and the technology must be approved by the competent authority. If no approval record is found, careful evaluation is advised.
What are the regulations on advertising and promotion under the Regenerative Medicine Act?
The Regenerative Medicine Act regulates the content of regenerative medicine advertisements, prohibiting false statements or exaggerated claims (e.g., claiming "no side effects" without approval). Violators may be penalized according to law. When encountering regenerative medicine advertisements, consumers can cross-check with the Ministry of Health and Welfare's approved information and report suspicious false claims to local health bureaus (source: relevant provisions of the Regenerative Medicine Act).
How to evaluate the scientific basis of stem cell anti-aging, NAD+ drips, and exosomes?
The level of scientific evidence varies among therapies; some are under research, while others have conditional approval. Stem cell therapy, due to its complex preparation, has had case reports of serious adverse events such as infections and tumors from unregulated treatments internationally. When evaluating, confirm the institution's approval status and physician qualifications, and have a qualified physician fully explain the indications, risks, and alternatives before deciding. Do not rely solely on advertising claims.
Where can I look up official regenerative medicine regulations and approved institutions?
References: ① National Laws and Regulations Database (law.moj.gov.tw) for the Regenerative Medicine Act and the Special Management Regulations; ② Ministry of Health and Welfare's "Cell Therapy Technology Information Zone" (celltherapy.mohw.gov.tw) for approved institutions and plans; ③ Ministry of Health and Welfare's Medical Affairs Management System (ma.mohw.gov.tw) to confirm institution business registration. This site provides neutral information; actual regulations are subject to the latest announcements by the competent authority.
What penalties will a clinic face for performing regenerative medicine without approval?
According to Article 30 of the Regenerative Medicine Act, medical institutions that perform regenerative techniques without approval and registration, or use regenerative preparations designated by the central competent authority, shall be fined not less than NT$100,000 and not more than NT$1,000,000, and their names may be published; if the circumstances are serious, they may be ordered to suspend part or all of their regenerative medical operations. If a non-medical institution illegally performs such actions, the penalty under Article 28 is heavier, with a fine of not less than NT$2,000,000 and not more than NT$20,000,000 (Source: Regenerative Medicine Act, National Laws and Regulations Database).
When did the Regenerative Medicine Act take effect? Is it legal to get stem cell injections at a clinic now?
When the 'Regenerative Medicine Act' and the 'Regenerative Medicine Preparations Act' were promulgated on June 19, 2024, the effective date was to be set separately by the Executive Yuan; on December 30, 2025, the Executive Yuan, by Order Tai-Wei-Tzu No. 1141035478, set the effective date as January 1, 2026, and subordinate regulations such as the 'Regulations Governing Regenerative Medicine Techniques and Designated Preparations' and the 'Regulations Governing the Publication and Broadcasting of Regenerative Medicine Advertisements and Recruitment Advertisements' also took effect on the same date. Therefore, starting in 2026, when clinics perform regenerative medicine such as stem cell therapy, both the institution and the technical items must be approved and registered by the Ministry of Health and Welfare, and may only be used for approved indications; according to statistics from the Ministry of Health and Welfare's 'Regenerative Medicine Technology Information Section,' 'anti-aging' is not among the approved indications. Before going, you can check in the section whether the institution and item are approved (Sources: Laws and Regulations Database legislative history; Lee and Li, Attorneys-at-Law, newsletter dated 2026-01-02).
This page is a neutral compilation of information for reference only, not medical advice, and does not constitute any diagnostic commitment.