Health & Beauty

In order to further improve the drug supply guarantee policy and meet the people's demand for a small amount of specific clinically urgently needed drugs such as clobazam that have been marketed abroad but not available in China, the National Health Commission and the State Drug Administration jointly issued the "Temporary Import of Clinically Urgently Needed Drugs". The Work Plan and the Work Plan for the Temporary Import of Clobazam (hereinafter referred to as the “Plan” and the “Clobazam Plan” respectively), released the list of 50 medical institutions that took the lead in importing and using clobazam.

The relevant person in charge of the National Health and Health Commission said that the formulation and announcement of the two plans will help to solve the problem of a small number of specific medical needs of patients. In addition, many of the drugs that need to be temporarily imported have been registered and marketed abroad for many years. Therefore, domestic capable manufacturers are encouraged to speed up imitation, and at the same time, overseas drug manufacturers that are urgently needed for clinical use are also encouraged to actively apply for registration and listing in China.

The "Plan" is a general guiding document, and is applicable to overseas marketed drugs that have not been registered and listed in China, have no enterprise production, or cannot resume production in a short period of time. Among them, a small amount of medicines urgently needed in clinics are medicines that meet one of the following conditions: medicines for the treatment of rare diseases; medicines for the prevention and treatment of serious life-threatening diseases for which there is no effective treatment or prevention means; medicines for the prevention and treatment of serious life-threatening diseases, and drugs with obvious clinical advantages.

According to the relevant provisions of the "Plan", the "Clobazam Plan" clarifies the application workflow, drug use management, and prescribing physician qualifications for the temporary import of clobazam on the basis of finding out the clinical drug demand and the qualifications of medical institutions in the early stage. Conditions and management requirements, rights and responsibilities of relevant parties, etc., as an individual plan for the management of the use of temporarily imported drugs.

The relevant person in charge of the National Health and Health Commission introduced that clobazam belongs to the second category of psychotropic drugs in the national catalog of narcotic drugs and psychotropic drugs. The requirements are clarified and refined. According to the evaluation of diagnosis and treatment capacity, in order to ensure the medication needs of patients in various places, at least one medical institution in each province can use clobazam.

At the same time, the "Clobazam Plan" clarified that the dosage of each prescription should not exceed one month at most, and announced the list of medical institutions leading the import and use of clobazam. Peking Union Medical College Hospital is the leading importing hospital. The conditions of the selected medical institutions include: tertiary hospitals; doctors with epilepsy subspecialties or related professionals, engaged in the diagnosis and treatment of epilepsy or children with epilepsy for more than 10 years; clinical safety use norms and emergency plans for clobazam, establishment of clinical, pharmacy, medical Multidisciplinary medical team.