cover news reporter Shao Meng
html On June 29, the cover news reporter learned from the National Health Commission that in order to further improve the drug supply guarantee policy and meet the people's needs for a small number of specific clinical medicines such as clobazam that have been marketed abroad but are not available domestically, In order to meet the urgent demand for drugs, the National Health Commission and the National Medical Products Administration jointly issued the "Work Plan for the Temporary Import of Clinically Urgent Drugs" and the "Work Plan for the Temporary Import of Clobazam" (hereinafter referred to as the "Plan" and "Clobazam" respectively). plan").Clobazam is a benzodiazepine drug that has been approved for marketing in many countries and regions and can be used as an auxiliary drug for the treatment of refractory epilepsy . However, according to my country's "Catalogue of Psychotropic Drugs (2013 Edition)", clobazam belongs to the second category of psychotropic drugs controlled by the state and is subject to strict control.
Since last year, families of rare epilepsy patients have jointly spoken out, and the shortage of specific drugs has attracted widespread attention. The formulation and announcement of the "Plan" and the "Clobazam Plan" are of great significance to steadily solve the problem of a small number of specific medical needs of patients, guide medical institutions to standardize clinical use, and ensure the safety of patients' medication. The National Health Commission stated that many of the drugs that need to be temporarily imported have been registered and marketed abroad for many years. Therefore, capable domestic manufacturers are encouraged to speed up imitation. At the same time, overseas drug manufacturers with urgent clinical needs are also encouraged to actively apply for registration in China. Listed.
The "Plan" is an overall guidance document and is applicable to small quantities of drugs that have been marketed overseas and are urgently needed for clinical use without domestic registration and production, or that cannot be resumed in a short period of time. Among them, drugs that are urgently needed for clinical use in small quantities are drugs that meet one of the following conditions: including drugs used to treat rare diseases; drugs used to prevent and treat serious life-threatening diseases for which there is no effective treatment or prevention method; drugs used to prevent and treat serious life-threatening diseases , and drugs with obvious clinical advantages.
reporter noted that the "Clobazam Plan" clarified the application workflow for temporary import of clobazam, drug use management, prescribing physicians' qualifications and management requirements, and the rights and responsibilities of relevant parties, etc., in accordance with the relevant provisions of the "Plan" , as an individual program for managing the use of temporarily imported medicines.
The "Clobazam Plan" also announced the list of medical institutions that take the lead in importing and using clobazam. Peking Union Medical College Hospital is the leading import hospital. It also includes Huashan Hospital Affiliated to Fudan University and Xiangya Hospital of Central South University , , Sichuan University West China Hospital and other 50 hospitals using it. The conditions for medical institutions selected for use include: tertiary hospitals; doctors with epilepsy subspecialties or related majors who have been engaged in the diagnosis and treatment of epilepsy or childhood epilepsy for more than 10 years; clinical safety use specifications and emergency plans for clobazam, and established clinical practice. , pharmacy and medical multidisciplinary diagnosis and treatment team.
In addition, since clobazam belongs to the second category of psychotropic drugs controlled by the state, the "Clobazam Plan" clarifies and details the conditions of medical institutions selected for use, the qualifications and management requirements of prescribers. Based on the evaluation of diagnosis and treatment capabilities, in order to ensure the medication needs of patients in various regions, each province has selected at least one medical institution that can use clobazam. The "Clobazam Protocol" also clarifies that each prescription must not exceed a maximum of 1 month's dosage.
It is reported that medical institutions can apply for temporary import based on actual clinical needs. Medical institutions that use temporarily imported drugs shall adopt corresponding measures such as formulating clinical technical specifications, establishing special management systems, formulating complete safety precautions and risk monitoring and handling plans, and fully inform them in accordance with the "Pharmaceutical Administration Regulations for Medical Institutions" and written informed consent to work.
leads the list of medical institutions that import and use clobazam. Source: Screenshot of the official website of the National Health Commission
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