The Executive Yuan announced today that, to enable the early application of cell therapy technology for those in need, it has integrated resources across ministries, facilitating the implementation of cell therapy for cancer and extensive burns among patients as early as this month.

According to a press release from the Executive Yuan, although conventional therapies in clinical medicine, such as medications and surgeries, can treat many diseases, there are still conditions that are challenging to address. Diseases like cancer, stroke, sequelae of cerebral hemorrhage, amyotrophic lateral sclerosis (ALS), and Alzheimer's disease still require innovative technologies and medical techniques to provide new solutions.

The Executive Yuan pointed out that the "Management Measures for Specific Medical Technologies, Examinations, Inspections, and the Use of Medical Devices" (referred to as "Specific Measures") will prioritize allowing medical institutions to carry out specific cell therapy procedures for severely ill patients, such as those with cancer, extensive burns, or degenerative arthritis, or for the elderly. The first batch of medical institutions is expected to start implementing these therapies as early as February this year, benefiting over 100,000 patients in the future.

The Executive Yuan stated that regenerative medicine brings a new treatment paradigm and propels modern clinical medicine to unprecedented heights. For example, in 2017, the U.S. Food and Drug Administration (FDA) approved two CAR-T cell therapies, not only bringing hope to cancer patients but also injecting vitality into cancer treatment. The development of regenerative medicine can benefit more patients, alleviate the suffering of cancer patients or others with severe illnesses, improve the discomfort and inconvenience in the lives of the elderly, and promote the clinical and industrial energy of domestic regenerative medicine. This, in turn, can attract foreign investment and development.

The Executive Yuan mentioned that Taiwan and Japan are currently the only two countries globally that view cell therapy as part of medical technology development. To lead the world in the development of the regenerative medicine industry and leverage Taiwan's medical advantages and clinical capabilities, the government aims to become the Asian center for cell therapy. The government has actively invested in creating a conducive environment for cell therapy management, innovative research and development in regenerative medicine, the development of peripheral products for cell therapy, and the establishment of cell preparation facilities. This effort aims to accelerate the diffusion of demand driven by the Specific Measures throughout the upstream, midstream, and downstream of the biomedicine industry.

Cell Therapy Mini-Encyclopedia

Definition:

Cell therapy refers to the use of cells obtained from the patient's own body, other organisms, or cells approved by the central competent authority. These cells undergo external cultivation and are then utilized to produce derived cells for the purpose of treating, diagnosing, or preventing diseases.

Derived Cells:

• Derived cells are classified as medical products and require rigorous quality control.

• In Taiwan, medical technology and devices are regulated by the "Medical Care Act," and related products are governed by the "Pharmaceutical Affairs Act" and the "Drug Inspection and Registration Examination Guidelines."

International Regulation:

• In regions such as the United States, Europe, Japan, South Korea, and Australia, most cell therapies adhere to risk management principles.

• Unless there are minimal alterations to the original biological characteristics, cell therapy is often categorized as biologics or medical device products in the regulatory pathways for market management, requiring proper licensing.

Quality Control:

• Strict quality control measures are necessary for the production of derived cells.

Regulatory Framework in Taiwan:

• Taiwan regulates medical technology under the "Medical Care Act" and related products under the "Pharmaceutical Affairs Act" and the "Drug Inspection and Registration Examination Guidelines."

Global Practices:

• In various regions such as the United States, Europe, Japan, South Korea, and Australia, cell therapy is managed as a biologic or medical device product in the market, with the requirement of obtaining proper licenses.

Source of Information:

• Ministry of Health and Welfare, Taiwan.

What is regenerative medicine? 

Regenerative medicine involves the use of cells, genes for the reconstruction or repair of human body structures or functions, and for the treatment or prevention of human diseases.

The scope includes regenerative medical technologies, formulations, or complex medical devices. Medical institutions or delegated cell and gene processing units prepare customized cells or genes and provide them for specific patients.

Source: Ministry of Health and Welfare