Five kinds of anti-tumor drugs on the market, including cisplatin injection, add information on medications for children

Recently, the State Food and Drug Administration issued an announcement that the corresponding specifications of the five anti-tumor drugs, cisplatin injection, ifosfamide for injection, azathioprine tablets, asparaginase for injection, and vindesine sulfate for injection, which have been marketed in China, are available. Refer to the announcement request to submit a supplementary application for amending the instructions to add information on children's medications. This is the second batch of announcements on the addition of children's drug information to the drug product inserts for marketed drugs since the State Food and Drug Administration launched the project to standardize children's drug use information in the drug product inserts already on the market.

　　 According to the announcement, the indications or usage and dosage of the five anti-tumor drugs have been added to the content of children's drugs. Take cisplatin injection as an example. The drug is currently one of the most widely used chemotherapeutic drugs for lung cancer, sarcoma and bladder cancer and other tumor indications. There are currently 27 approval numbers for cisplatin injection in my country. Based on the original drug instructions, the announcement adds children-related content under [Usage and Dosage]: "For single-drug therapy, the following two doses are recommended: 50~120mg/㎡ every 3~4 weeks; 15~20mg/㎡/d continuous Repeat every 3~4 weeks for 5 days; if combined with chemotherapy, the recommended dosage is 20mg/㎡ or higher, once every 3~4 weeks, but should not exceed the single dose of cisplatin. According to the weight of the child, this product should be used in an appropriate amount Diluted and instilled sodium chloride injection.". [Usage and Dosage] The clear statement on children's medication under the item will help the standard and safe use of this product in clinical practice.

　　 The issue of children's medication has always been a concern. The "China Children's Development Program Notice (2021-2030)" issued by the State Council recently specifically mentioned that "Improve the clinical drug specifications for children, and the drug insert clearly expresses the information on children's drug use." The State Food and Drug Administration attaches great importance to the standardization of children's drug instructions, in order to guide enterprises to improve drug instructions, improve the accessibility and safety of children's medications, and promote clinically standardized and rational drug use. The Drug Evaluation Center of the National Food and Drug Administration and the National Children's Medical Center (Beijing Children's Hospital) In June 2018, jointly established the "Project for Standardization of Children's Drug Use Information in Listed Drug Inserts" to research and demonstrate the addition of children's drug information to children's clinically commonly used drugs. The State Food and Drug Administration made reasonable use of real-world evidence under the premise of strict scientificity. In June of this year, it released the first batch of marketed drugs, haloperidol tablets, risperidone oral preparations, and fluoxetine oral preparations. Add information on medications for children. This time, on the basis of summarizing the previous work experience, we will continue to release the second batch of five anti-tumor drug instructions on the market to increase the use of children's drug information, benefiting more children.

　　 It is understood that in September this year, the Drug Evaluation Center of the State Food and Drug Administration issued the "Technical Guidelines for the Writing of Children's Drug Information in the Instructions for Chemical Drugs and Therapeutic Biological Products (Trial)". This is my country's first special guiding principle for the standardized writing and revision of children's medication information in drug inserts. The issuance of this guiding principle will effectively promote the further improvement of the information on children's medication in my country's drug inserts and improve the safety of children's medication.