Physician Law of the People's Republic of China for the first time legally confirms the legitimacy of off-label drug use by physicians,but it does not clarify whether medical ethics review is required for its application.This article argues from the following four dimensions that medical ethics review is not a necessary prerequisite procedure for off-label drug use:current legal regulations has no mandatory requirement;the industry has no unified consensus or rules;comparative law investigations cannot provide reference or support;and from a risk perspective,the stakeholder groups involved in off-label drug use are clear,and the risks are relatively controllable.However,off-label drug use still poses certain risks to patients.Therefore,it is crucial to strictly adhere to legal requirements,limit its use to special cases where there is no effective or better treatment available,ensure patient benefits outweigh risks,obtain thorough informed consent,have evidence-based medical support,and undergo internal hospital review before application.
off-label drug usemedical ethics reviewPhysician Law of the People's Republic of China
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