Abstract: With the Law on Doctors of the People's Republic of China implemented on March 1， 2022， off-label use of drugs has been included into the legislation for the first time. The ^{Law on Doctors of the People's Republic of China} stipulates： "In the absence of effective or better treatment approaches and other special circumstances， after obtaining the informed consent of the patient/guardian/entrusted agent， the clinician can undertake a usage not specified in the drug instruction if supported with evidence. Medical institutions are suggested to establish a management system to review the suitability of prescriptions and medications ， and strictly standardize the medication behavior of clinicians". In view of this， Peking Union Medical College Hospital established the management system for off-label drug use based on evidence-based methods with the aim to strengthen its management and rational use in our hospital. The measures for off-label drug use were formulated to safeguard doctor's legitimate rights， as well as to strictly standardize practicing behavior. Contingency plans were established for risk prevention and control to protect patients' rights and escort the off-label use of drugs. Hierarchical management based on the patients’ needs and the types of evidence sources for offlabel medication use was adopted to improve its feasibility.