Abstract
Unregistered drug use,also called off-label drug use,has become a universal phenomenon in clinical practice worldwide.At present,there is still no definite laws and regulations in the field of off-label medication in China.The article gives an overview about the current criterion for prescription in China,the definition of off-label use,analysis of this situation and causes,how to regulate this practice to protect the patient's rights and safety,and also doctor's rights of prescription. Key words: Off-label use; Laws and regulations; The Declaration of Helsinki
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