Taiwan's fastest immune cell therapy for routine treatment in July and allows for fees
Recently, according to Taiwan media reports, Taiwan's Weifu Department will open human cell immunotherapy for routine treatment! After the announcement in the future, the items listed in the method can be used for routine treatment of patients and charged, but the treatment hospitals, laboratories and physicians must comply with the regulations, and report the annual treatment results, if successful. The fastest will be released in July. It is understood that Taiwan's current cellular immunotherapy can only be carried out by applying the "goodness clause". The Weifu Department recently proposed to amend the special medical technology inspection and inspection medical instrument management methods, and add a special chapter on cellular immunotherapy. Shi Chongliang, director of the medical department of Weifu Department, said that more than 5,000 people submitted proposals for the public policy network platform in 2015, and hope that the Taiwan authorities can fully and quickly open up cellular immunotherapy for cancer treatment. After discussion, Weifu Department has conditionally lifted the ban in 2016, but the patient needs to be “life-threatening or severely disabledâ€, “there is no suitable medicine or alternative therapy in Taiwanâ€, and the physician needs to set up a “subsidiary planâ€. This is the “gift clause†mentioned above. Shi Chongliang further pointed out that with the advancement of cellular immunotherapy and the treatment of cancer patients in Taiwan, the Department of Health and Welfare intends to open cell immunotherapy for routine treatment. Cancer patients can also undergo chemotherapy and radiotherapy. As an adjuvant therapy, immunotherapy has drawn up a draft management plan to treat cellular immunotherapy with special medical technology and to follow the “registration trackingâ€. As for which cellular immunotherapy and indications can be done, the method will be positive. Listed, T cell therapy, natural killer cells (NK) and CAR-T are discussed and will be discussed at expert meetings. Previously, the Taiwan Food and Drug Administration used the "Pharmaceutical Affairs Law" to manage emerging therapies such as cell therapy and gene therapy. According to the regulations, the drugs for trial use must be first certified and then sent to the teaching hospital for clinical trials in Phases I to III. Qi Ruofeng, deputy head of the Drug Administration of the Food and Drug Administration, said: Some patients are in urgent need of immediate medication, and in the absence of medicine, patients can only go abroad for treatment. At the same time, they are managed by the Pharmaceutical Affairs Law. There are indeed deficiencies and inadequacies in the unique products. Therefore, the Food and Drug Administration decided to establish a special law management and issue the “Draft Cell and Gene Therapy Product Management Lawâ€, which defines the definition of cell and gene therapy products, and sets a temporary licensing mechanism, as long as the donors are confirmed. Appropriate matching, and the risk of non-infectious diseases in cell or gene therapy products, under the premise of ensuring safety, it is not necessary to complete the three-phase test and can also temporarily permit the use of drugs, which means that the patient is not nuclear Huai can also be used first before the market. At present, the details of the temporary licensing mechanism for cell and gene therapy are still under discussion.
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