2018-09-13| Policy

Taiwan Approves Six Cell Therapies Under Revised Guidelines

by Rajaneesh K. Gopinath
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By Rajaneesh K Gopinath, Ph.D.

On September 4th, the Ministry of Health and Welfare (MOHW) in Taiwan issued the revised version of the “Administrative guidelines for the implementation of Medical Devices and Specific Medical Technology”. To that end, the following six cell therapies are officially approved for patients from September 6th (Table 1).

Project Indications
Autologous CD34 + selection peripheral blood stem cell transplantation
  • Hematological malignancies: leukemia (excluding chronic phase of chronic myeloid leukemia), lymphoma, multiple myeloma
  • Chronic ischemic stroke
  • Severe lower limb ischemia
Autoimmune cell therapy
  • Hematologic malignancies are ineffective by standard treatment
  • First to third stage solid cancer, invalid by standard treatment
  • Solid cancer phase IV
Autologous adipose stem cell transplantation
  • Chronic or difficult wounds that have not healed for six weeks
  • Large area burns or skin wounds that account for more than 20% of the total surface area
  • Subcutaneous and soft tissue defects
  • Degenerative arthritis and knee cartilage defects
  • Combination or adjuvant therapy for other superficial minimally invasive techniques
Autologous fibroblast transplantation
  • Skin defects: filling and repair of wrinkles, pits, and scars
  • Subcutaneous and soft tissue defects
  • Combination or adjuvant therapy for other superficial minimally invasive techniques
Autologous bone marrow mesenchymal stem cells
  • Degenerative arthritis and knee cartilage defects
  • Chronic ischemic stroke
  • Spinal cord injury
Autologous chondrocyte transplantation
  • Knee articular cartilage defect

Table 1. Types of cell therapies to be available in Taiwan


Expanding the scope of application in patients

A draft of the revised guidelines was released earlier this year and after careful consideration of critical feedback from medical associations, industrial experts, and academic institutes, it is now officially implemented. The Minister of Health and Welfare, Dr. Chen Shih-Chung said that the primary focus of cell therapy is still on safety. Patients who have been deprived or experienced poor therapeutic effects in the past can avail of the services and hope to expand their lives under the new technology.

Chongliang Shi, the Director-General of Medical Affairs at MOHW said that cell therapy, which has become routine medical care, has high safety and low risk, and has been proven to have appreciable efficacy. As for the updated technology, if domestic human trials, accumulated key data and published it in domestic and foreign literature reports, it could speed up the early application of cell therapies in patients.


Cell therapy will be open and transparent

Another major point of amendment in the special guidelines is that Article 18 stipulates: “The implementation of cell therapy technology by medical institutions shall be reported at the end of each year for three months or within the time limit required by the central competent authority.” The results of the report must include the number of treatment cases, treatment effects, adverse reactions or abnormal events. Moreover, the results of the treatment conducted in medical institutions would be disclosed whenever necessary. This would subvert the stem cell storage or immunotherapy market to focus only on marketing and price competition strategies because now people outside the patient can immediately know whether cell therapy had any effect, and the future of the cell therapy market will be determined purely by professionals.


Regulations on the Management of Regenerative Medical Preparations might quickly improve

The MOHW is also currently drafting the “Guidelines on the implementation of Regenerative therapies” and expects it to be passed soon. The law will shorten the period of listing of regenerative medical preparations using donor suitability assessment, conditional time permit system, and strengthen the establishment of post-marketing safety monitoring and other regulations to ensure the quality, safety and effectiveness of regenerative medical preparations, safeguard patient rights, and promote the development of regenerative medical preparations by Taiwanese biotech manufacturers.

The MOHW also hopes to improve the Taiwan cell therapy technology and regulatory environment through the special regulations on Regenerative Medical Preparations. Phased open-cell therapy technology will enable cell therapy to be applied to patients in need as soon as possible and through effective management. Patient safety and medical quality, and can promote Taiwan’s overall biotechnology research and development and industrial development.



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