The health ministry has decided to require clinical proof that anticancer drugs prolong human life before they can get government approval, officials said Wednesday.
Mandatory clinical tests are now required only to prove drug safety and efficacy in fighting cancer. The new tests will be added to existing ones.
The Health, Labor and Welfare Ministry came to the decision because some patients taking anticancer medications suffer strong side effects while undergoing treatment, and their lives are not always prolonged as a result, the officials said.
The new tests will be required beginning in April for drugs used to treat common cancers such as non-small-cell lung cancer, stomach cancer, colon cancer and breast cancer.
Data proving that a drug prolongs human lives can be obtained either in Japan or overseas, the officials said.
During clinical tests, a large number of patients who take experimental drugs and placebos are monitored for a specific period to obtain data on both their efficacy and potentially harmful side effects.
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