The Ministry of Health and Welfare announced the amendment of the "Regulations for the Implementation or Use Management of Specific Medical Technology Examinations and Inspections of Medical Instruments" (referred to as the Special Management Measures), opening up six cell therapy technologies. The applicable subjects include autologous immune cell therapy for cancer patients with standard treatment failure and physical end-stage cancer patients; autologous chondrocyte transplantation for knee cartilage defects; autologous adipose stem cell transplantation for large-area burns and difficult-to-heal wounds, among others. Additionally, the Ministry of Health and Welfare is actively promoting the legislation of the "Regulations for the Management of Regenerative Medical Preparations (draft)," which aims to shorten the market entry period for regenerative medical preparations and enhance safety monitoring. The dual regulations will construct a comprehensive management system for regenerative medicine in Taiwan, promoting the development of the biopharmaceutical industry.

According to the Ministry of Health and Welfare, under current regulations, cell therapy must undergo human trials in accordance with medical laws. To expedite the application of cell therapy to those in need, the Special Management Measures have been amended to open up cell therapy projects with proven safety and expected efficacy in other countries or those with a certain number of cases in domestic human trials. The Ministry has outlined relevant regulations to ensure the quality of implementation and protect patient rights. Key points of the amended measures include:

• Medical institutions must develop a plan and obtain approval from the competent authority before implementing cell therapy techniques.

• Annual reports on the results of cell therapy implementation must be submitted to the competent authority by medical institutions.

• Those involved in the cell therapy process, including cell processing, cultivation, or storage, must have facilities meeting Good Tissue Practices (GTP) standards and pass inspections by the competent authority.

The Ministry of Health and Welfare's Food and Drug Administration has completed the draft of the "Regulations for the Management of Regenerative Medical Preparations" (formerly the draft Cellular and Gene Therapy Management Act), which is currently under review by the Executive Yuan. The proposed regulations include assessments of donor suitability, conditional term permit systems, and strengthened post-market safety monitoring, aiming to ensure the quality, safety, and effectiveness of regenerative medical preparations, safeguard patient rights, and promote the development of regenerative medical preparations in Taiwan. Through these regulatory amendments and formulations, a robust regulatory environment for cell therapy technology is established, progressively opening up cell therapy technologies to benefit patients in need. Effective management safeguards patient safety and medical quality, promoting the development of biotechnology and industry.

Table Three

Project Name: Transplantation Indications

I. Autologous CD34+ Selection Peripheral Blood Stem Cell Transplantation

Hematological Malignancies:

• Leukemia (excluding the inactive phase of myelodysplastic syndrome).

• Lymphoma.

• Multiple myeloma.

• Inactive subclavian artery stroke.

• Severe hemosiderosis.

II. Autologous Immune Cell Therapy (Including CIK-NK-DC-DC-CK, TIL, γ-δ T Lymphocytes, etc.)

Hematological Malignancies:

Ineffective standard treatment.

• Solid Tumors:

• Stages I to III, ineffective standard treatment.

• Stage IV.

III. Autologous Adipose Stem Cell Transplantation

• Incomplete healing of spontaneous or trauma-induced oral cavity.

• Large-area burns or skin injuries covering twenty percent (inclusive) or more of the total surface area.

• Inflammatory and damaged tissue closure.

• Osteoarthritis and knee joint bone defects.

• Other surface minimally invasive techniques combined or used as adjunctive therapy.

IV. Autologous Fibroblast Cell Transplantation

• Skin defects: filling and repair of wrinkles, hollows, and scars.

• Subcutaneous and tissue defects.

• Other surface minimally invasive techniques combined or used as adjunctive therapy.

V. Autologous Bone Marrow Mesenchymal Stem Cell Transplantation

• Osteoarthritis and knee joint bone defects.

• Chronic ischemic stroke.

• Scoliosis.

VI. Autologous Chondrocyte Transplantation

• Knee joint bone defects.