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Select elite hospitals in China could soon be able to sell experimental therapies that engineer a patient’s own cells to treat diseases such as cancer — without approval from the nation’s drug regulator. The proposal comes three years after the government shut down the sale of unapproved cell therapies following the death of a student who had received such a treatment.

The draft policy has prompted mixed responses. Some scientists say that it would give people with terminal illnesses faster access to potentially effective treatments, and that the measures would protect patients from dangerous therapies. But others question whether the regulations do enough to ensure that the treatments are safe and effective before they are sold.

In many countries, the use of cell therapies — treatments made from human cells, often from the immune system — requires approval from drug regulators, which means rigorous, costly and time-consuming clinical trials to show that they are safe and effective. Some countries have policies, such as Australia’s Special Access Scheme, that allow doctors to administer unapproved cell therapies under special conditions, such as a patient being terminally ill.

…continue reading ‘Chinese Hospitals Set to Sell Experimental Cell Therapies’

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Nature

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