Control of safety and efficacy of cell therapy

Draft regulations on clinical trials (CTT) of new techniques and new methods in medical examination and treatment, including regulations on cell application research, stages of CTT of cells and cell products.

Dr. Ngo Quang said that the Ministry of Health will have regulations on TNLS and application of cell products and cell therapy.

According to Dr. Ngo Quang, many medical facilities are currently applying cell therapy in violation of regulations. In particular, many cell therapy methods (stem cells, immune cell therapy) in treatment and health care are promoted but have not been scientifically proven, can cause consequences for people, or have unclear effectiveness causing costs.

Cell therapy is a new method, a new technique. Before implementing research, it must be reviewed, evaluated, and approved by the National Council of Ethics in Biomedical Research. The research process must be evaluated for safety and effectiveness. Once applied, it still needs to be evaluated after application, so that the management agency can consider approving continued implementation or stopping. The final product of cell technology must be controlled for safety and effectiveness, avoiding misuse that is costly and does not bring about the advertised results.

The Ministry of Health is completing the system of legal documents regulating research, clinical trials and the application of cell therapies in treatment and health care for the people. The regulations must ensure the principle of encouraging the development of science and technology but not spontaneously and must be safe and effective.

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