Reporters Li Jing Li Yansong
Patients with rare epilepsy have been waiting for clobazam.
html On June 29, the National Medical Products Administration issued a "Notice on the Issuance and Issuance of Drugs and Drugs" on its official website, stating that in order to further improve the drug supply guarantee policy and satisfy the people's concerns about Clobazam and other drugs that have been marketed abroad and are not available in China, supply of a small amount of specific urgently needed clinical drugs, and took this opportunity to form a relatively complete temporary import plan for urgently needed clinical drugs. The National Health Commission and the State Food and Drug Administration recently issued the "Work Plan for the Temporary Import of Clinically Urgent Drugs" and "Clobazam Temporary Import Work Plan." Among them, a list of 50 medical institutions taking the lead in importing and using clobazam was released.Clobazam is a broad-spectrum anti-epileptic seizure drug that is very effective in treating rare epilepsy diseases and can effectively control epileptic seizures. Up to now, clobazam is available in many countries including the United Kingdom, France, and Germany. However, in China, clobazam belongs to the second category of psychotropic drugs, which is strictly controlled and has not been approved for marketing. The announcement of the
plan means that clobazam can finally be imported, which also brings hope to the patient group. Previously, Qilu Evening News and Qilu One Point published "Drug embarrassment - 1042 parents of children with rare epileptic encephalopathy publicly search for clobazam" "This "life-saving drug" for rare diseases is planned to be temporarily imported, and the patients' families hope that it will be implemented as soon as possible" In the first trial of the "Iron Horse Glacier" overseas purchase of clobazam case, the lawyer defended his innocence and said it was not drug trafficking" and other reports, continued to pay attention to the rare epilepsy disease group and the "clobazam" drug.
Patient’s family members: Keep waiting, hoping to get the treatment as soon as possible
html On June 30, the reporter contacted the patient’s father, “Daddy Songsong.” "Songsong Dad" said, "I saw the news yesterday. The country has given a plan to provide our patients with a way to apply from the hospital, but the details still need to be implemented by the hospital. In the end, our patients will be able to buy medicines from the hospital. In fact, there is still a long way to go. "reporter learned that the "Clobazam Temporary Import Work Plan" is based on the relevant provisions of the "Temporary Import Work Plan for Clinically Urgent Drugs" to find out the basis for clinical drug demand and medical institution qualifications in the early stage. It clarified the application workflow for temporary import of clobazam, drug use management, qualifications and management requirements of prescribers, rights and responsibilities of relevant parties, etc., as an individual plan for the management of temporary imported drug use. Zhang Yulan (pseudonym), the mother of
patient, also paid attention to the announcement of the plan. Her daughter Mengmeng was diagnosed with "tuberous sclerosis" and "refractory epilepsy" when she was less than one year old. Mengmeng is always crying, nodding, bending her knees, and twitching. In severe cases, the number of convulsions can reach forty or fifty times a day. "During the attack, my eyes stared straight, my body spasmed, and it was very painful." Zhang Yulan took care of her children as if she were taking care of an old man with hemiplegia.
Now, Mengmeng has less than three months of clobazam left. Zhang Yulan told reporters: "Many of our patients' families hope to implement it quickly and buy medicines from nearby authorized hospitals as soon as possible. We also hope to buy them reasonably, legally and formally."
"Some families are now changing medicines, and many families have already stopped. Medicine." Songsong's father said, "Although we know this is about to happen, we don't know how long we will have to wait. Our only need is to get medicine from the hospital as soon as possible. "
Pharmaceutical company: Patients can expect to buy domestic clobazam tablets in September
"Domestic clobazam tablets have been approved for marketing and will not be available for sale until the end of September. Our patients will not be able to use this medicine until September. At the end of the month." Songsong's father revealed in the interview.
In December last year, according to CCTV News the State Food and Drug Administration stated that so far, eight companies have been approved to develop clobazam in accordance with relevant regulations. No domestic company has yet submitted a marketing application for clobazam preparations. However, two companies have submitted clinical trial applications and obtained clinical approval.
On April 12 this year, Yichang Renfu Pharmaceutical published on the official WeChat public account "The company's application for marketing authorization of clobazam tablets has been accepted", showing that the company's clobazam tablets 10mg and 20mg have submitted marketing authorization applications. , and successfully accepted. On May 11, the official website of the Drug Evaluation Center showed that Yichang Renfu ’s clobazam tablets had been announced for priority review.
Yichang Renfu pointed out that the company received project approval for the development of clobazam tablets in 2018 and started research and development. It applied for clinical application in November 2020 and obtained clinical approval in February 2021. “The company is currently accelerating the research and development process in response to the urgent needs of society. The marketing authorization application for this product has been submitted to CDE. The company will continue to follow up on the process of this product to ensure its smooth launch, improve the accessibility of this product in the Chinese market, and better meet the health needs of the people.”
National Health Commission. Health Committee: Each province has selected at least one medical institution to use clobazam as a rare disease drug. News about clobazam has always affected the hearts of family members of patients with rare epilepsy.
In July last year, Iron Horse Glacier was arrested by investigators from the Zhongmu County Public Security Bureau in Henan Province for purchasing clobazam from abroad. Li Fang and other four mothers of patients with rare epilepsy were also involved in the case for helping Tiema Glacier collect Clobazam packages purchased overseas. The Zhongmou County People's Procuratorate prosecuted "Tiema Glacier" for smuggling, transporting and selling drugs; it decided not to prosecute Li Fang and four others.
Purchasing agents have gradually "died down", and there is a shortage of clobazam drugs for people with rare epilepsy diseases. On November 29 last year, more than 1,042 families of children with the rare disease epilepsy sent a letter asking for help - "How to keep our children alive?" 》. The cases of "drug dealer father" and "drug dealer mother", as well as rare epilepsy disease groups, once attracted attention.
On March 18 this year, the case of "Iron Horse Glacier" purchasing Clobazan was held in a public hearing at the Zhongmou County People's Court, and the verdict was announced at a later date. On April 15, "Iron Horse Glacier" was released on bail pending trial.
On March 29 this year, the National Health Commission and the State Food and Drug Administration drafted the "Work Plan for the Temporary Import of Clinically Urgent Drugs" and the "Work Plan for the Temporary Import of Clobazam" to solicit public opinions. In response to patients' medication needs, the National Health Commission proposed in the plan a list of 50 medical institutions that plan to take the lead in importing and using clobazam. The announcement of such a plan brings hope to the patient group.
html On June 29, the State Food and Drug Administration issued a notice on the issuance of the "Work Plan for the Temporary Import of Urgent Clinical Drugs" and the "Work Plan for the Temporary Import of Clobazam."According to . In addition, 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 and listing in China. 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.
It is worth noting that the "Work Plan for the Temporary Import of Clobazam" stipulates that each prescription must not exceed a monthly dosage, and announced a list of medical institutions that take the lead in importing and using clobazam. Peking Union Medical College Hospital is the lead importer. Hospital. The conditions for medical institutions selected for use include: tertiary hospitals; doctors with epilepsy subspecialties or related specialties who have been engaged in the diagnosis and treatment of epilepsy or childhood epilepsy for more than 10 years; have clinical safety usage specifications and emergency plans for clobazam, and establish clinical and pharmaceutical , medical multidisciplinary diagnosis and treatment team.
