(People’s Daily Health Client Reporter Wang Aibing) “In order to meet the urgent need for clinical use of clobazam, a work plan for the temporary import of clobazam was formulated in accordance with the relevant provisions of the “Work Plan for the Temporary Import of Drugs in Urgent Clinical Need”.” March 29, The National Health and Medical Commission issued an announcement for public comments on the “Provisional Work Plan for the Temporary Import of Clobazam”.
Previously, the People’s Daily Health Client continued to post that many families of children with rare diseases have posted information for help. Their child developed infantile spasms, Dravet syndrome, LGS syndrome, Ohtahara syndrome, tuberous sclerosis complex, Fires syndrome, sequelae of encephalitis, epilepsy in infants with migratory focal seizures (EIMFS) and more Epilepsy encephalopathy – these are rare diseases.
These children need to take a medicine called clobazam. According to the Catalogue of Psychotropic Drugs (2013 Edition), clobazam belongs to the second category of psychotropic drugs in China and has not been approved for sale in China. The family members of the children can only purchase clobazam from abroad, so most of them are already at risk of discontinuing the drug.
“Because of the lack of medicines recently, we hope to help our children by sending help to the whole society through real-name cooperation.” In December 2021, the family of the child, “Songsong Dad”, told the Health Times reporter. According to preliminary statistics, more than 1,600 children need to take clobazam, and most of them are already at risk of discontinuation.
“After the public consultation on the temporary import work plan for clobazam was issued, I sent this message to our families of children. These procedures are not well understood, and during this period of time, many children have faced the problem of drug withdrawal, so parents also hope to quickly take this drug through legal channels.” Song Song, a family member of the child, said A reporter from the People’s Daily Health Client said.
Another parent who once helped us because their children could not buy clobazam heard the news and sent four consecutive thanks, “Thanks to the country for giving children a chance to take medicine normally. “
It is understood that on March 11, Yichang Renfu Pharmaceuticals submitted a Class 3 generic marketing application for clobazam tablets and was sponsored by the Drug Evaluation Center of the State Food and Drug Administration. According to the above plan, the medical institutions that intend to lead the import and use of clobazam include 50 medical institutions including Peking Union Medical College Hospital, Peking University First Hospital, Beijing Children’s Hospital, and Huashan Hospital affiliated to Fudan University.