Recently, the Taiwan Food and Drug Administration announced on July 26 the "Draft Cell and Gene Therapy Product Management Law" (hereinafter referred to as the draft). The "Draft" defines the definition of cell and gene therapy products, while at the same time ensuring the safety situation A sexual permit means that the patient can preempt the drug before it is released.
It is reported that the Taiwan Food and Drug Administration manages cell therapy, gene therapy and other emerging therapies under the current Regulations of the Pharmaceutical Affairs Law. 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. Mr. Qi Ruofeng, deputy head of the Pharmaceutical Group of the Taiwan Food and Drug Administration, said that 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, the "Pharmacy Law" is used to manage such cases. Products with unique characteristics are indeed inadequate and inappropriate, therefore,
Based on the above situation, the Food and Drug Administration decided to establish a special law management system, which is to establish a temporary licensing mechanism. As long as the donors are properly matched and the cell or gene therapy products are free of infectious diseases, safety can be ensured. Under the premise of sex, it is not necessary to complete the three-phase test and it can be used for temporary permission.
Ruo Ruofeng said that because cell and gene therapy products involve the appropriateness of donors, if quality management is not appropriate, it is easy to derive infection risk, and the draft can provide legal norms to ensure the quality, safety and efficacy of cell and gene therapy products. To promote patients' right to receive treatment for emerging products.
At present, the details of the temporary licensing mechanism for cell and gene therapy are still under discussion, and the draft will conduct a 60-day comment period and solicit opinions from all walks of life, and then will be sent to the Executive Yuan for approval and then sent to the court for legislation.
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