The draft regulations on clinical trials of new techniques and methods in medical examination and treatment include regulations on cell-based research, the stages of cell-based clinical trials, and cell-derived products.
Dr. Ngo Quang stated that the Ministry of Health will issue regulations on clinical trials and the application of cell-derived products and cell therapy.
According to Dr. Ngo Quang, many medical facilities are currently applying cell therapy improperly. In particular, many cell therapy methods (stem cells, immunotherapy) in healthcare are being promoted but have not been scientifically verified, potentially causing harm to patients or yielding unclear and costly results.
Cell therapy is a new method and technique. Before conducting research, it must be reviewed, evaluated, and approved by the National Biomedical Research Ethics Committee. The research process must include safety and efficacy assessments. Even after application, post-application evaluations are still necessary for regulatory agencies to consider whether to continue or stop implementation. The final product of cell technology needs to be controlled for safety and efficacy to prevent misuse, which would be costly and not deliver the advertised results.
The Ministry of Health is finalizing a legal framework regulating research, clinical trials, and the application of cell therapies in the treatment and healthcare of the population. These regulations must ensure the principle of encouraging scientific and technological development while preventing spontaneous development and guaranteeing safety and effectiveness.
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