What happens to the burden on patients and their families when a new drug is available?
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Drugs are controlled by laws set by the government.
Because drugs are directly put into or applied to the human body, they are strictly controlled by the Pharmaceutical Affairs Law (Yakuji Hou), a national law concerning pharmaceuticals. In Japan, the national government (the Minister of Health, Labor and Welfare and prefectural governors) conducts inspections regarding quality, efficacy, and safety, and only products that pass these inspections are sold. Only those products that have passed the quality, efficacy, and safety examinations are marketed in Japan.
