On June 8, 2007, the Ministry of Health and Welfare announced the “Draft Amendment to the Administration of the Implementation or Use of Medical Devices for Specific Medical Technology Inspection and Inspection” (hereinafter referred to as the Special Administrative Measures), in which the cell treatment programs and indications for clinical treatment are clearly defined. And related management practices. Wei Fu said that after the announcement of the revised draft of the special control measures, it did receive many inquiries and suggestions from various circles on the relevant provisions of cell therapy. In order to explain the key points of revision of the law and actively explain the problem, the briefing session was held on July 17 to invite medical treatment. The institutions, industry and research institutes attended the event. Participants were more positive about the direction of the amendments. The briefings and Q&A of the briefings were also published on the website of the Department of Health and Welfare for reference. The draft notice period will end on August 13 and is expected to be submitted to the statutes for review in late August and will be released in September.
According to the current regulations, the Department of Health and Welfare is required to carry out human trials in accordance with the provisions of the Medical Law. In order to enable cell therapy technology to be applied to people in need as soon as possible, the special management measures will be implemented abroad, and the risks will be low, or Has been implemented in the country to accumulate a certain number of cases, a safe and predictable cell treatment program, open for use in clinical treatment cases that meet the indications, and have relevant regulations to ensure the implementation of quality, to protect patients rights and interests. After consulting the recommendations from various circles, the principles of the standard are as follows:
1. The medical institution shall formulate a cell treatment plan to apply for approval to the central competent authority, and it shall be registered by the competent authority of the municipality or county (city) and shall be implemented. The central competent authority shall apply for extension of the application for the cell treatment plan applied by the medical institution, and the medical institution shall submit an annual implementation result report to the central competent authority every year. If it affects the rights and safety of the patient, If the number of adverse events or the severity of the abnormality is abnormal, the execution will be terminated.
2. The cell treatment plan of a medical institution shall state the implementation of the physician, implementation project, treatment plan, fee and fee method, effect tracking, consent form and adverse reaction relief measures, etc., relevant information and annual implementation of various medical institutions. The summary of the results report will also be made available to the public on the website of the Department.
3. For those involved in cell processing, culture or storage, a cell preparation site that meets the relevant specifications for human cell tissue good operation (GTP) should be prepared or entrusted, and checked by the competent authority. The checker will pass the validity period of the nuclear validity period, and the application period will be extended after the expiration of the validity period. During the validity period, the Weifu Department may conduct irregular inspections. If the verification fails, the relevant medical treatments of the medical institutions entrusted to the site will be terminated. project.
4. In addition to the medical records, the medical institution shall make another record and keep it for 10 years. If the patient receiving the cell therapy has serious adverse reactions, it shall notify the competent authority within 7 days.
Wei Fu Department stressed that in order to respond to the major amendments to this special management method, the standards for the implementation of the education training courses for physicians, the procedures for applying for the implementation of cell therapy plans by medical institutions, the model of patient consent, and the application plan and the year will be announced simultaneously. The results report format, etc., so that the method can go on the road smoothly, and the cell therapy technology can be effectively managed, benefiting more cancer patients and promoting the development of China's biotechnology industry. Any suggestions for the draft notice may be made on the platform of the CDC Public Policy Network, or contact the Medical Department of the Ministry of Health and Welfare.
Source: Ministry of Health and Welfare Medical Affairs Division https://www.mohw.gov.tw/cp-16-43154-1.html