Classified management of national anti-tumor drugs

Legal analysis: According to the characteristics of tumor chemotherapy drugs, drug prices and other factors, tumor chemotherapy drugs are divided into special management drugs, general management drugs and clinical trial drugs for management.

(1) Specially managed drugs: refers to tumor chemotherapy drugs with low safety of drugs themselves or drug packaging, which may cause serious harm to human body once the drug packaging is damaged, with relatively high price and special storage conditions, which may cause serious adverse reactions.

(2) Drugs under general management refer to drugs that are not included in special management and non-clinical trials and belong to the scope of general management.

(3) Drugs used in clinical trials refer to tumor chemotherapy drugs used in clinical trials.

(IV) See the Annex for the Catalogue of Classified Management of Chemotherapeutic Drugs for Cancer in Hospital, which covers chemotherapy drugs for cancer in our hospital. When introducing new varieties, the classification management level should be clearly defined at the same time.

Legal basis: Administrative Measures for Clinical Application of Antitumor Drugs (Trial) issued by the National Health and Wellness Committee.

Article 1 These Measures are formulated to strengthen the management of clinical application of antineoplastic drugs in medical institutions, improve the level of clinical application of antineoplastic drugs, and ensure medical quality and medical safety.

Article 2 The term "antineoplastic drugs" as mentioned in these Measures refers to drugs that act on cellular and molecular levels through cell killing, immune regulation and endocrine regulation, generally including chemotherapy drugs, molecular targeted therapy drugs, immunotherapy drugs and endocrine therapy drugs.

Article 3 The National Health and Wellness Commission is responsible for the supervision and management of the clinical application of antineoplastic drugs in medical institutions throughout the country.

The local health administrative departments at or above the county level shall be responsible for the supervision and management of the clinical application of antineoplastic drugs in medical institutions within their respective administrative areas.

Article 4 These Measures shall be applicable to the management of clinical application of antineoplastic drugs in medical institutions at all levels that carry out diagnosis and treatment of tumors and apply antineoplastic drugs.

Article 5 The clinical application of antineoplastic drugs shall follow the principles of safety, effectiveness and economy. Medical institutions and medical personnel should take evidence-based medical evidence as the basis, diagnosis and treatment norms, clinical guidelines, clinical pathways and drug instructions as the basis, fully consider the clinical therapeutic value and accessibility of drugs, and rationally use anti-tumor drugs to achieve the purpose of treating tumors, improving the survival rate of patients and improving the quality of life of patients.