Shopcim occupation can be imported!Family members of patients with rare diseases: continue to wait, hope to land as soon as possible

Reporter Li Jing Li Yansong

Patients with rare epilepsy have been waiting for clotal occupation.

On June 29, the State Drug Administration issued a notice on its official website "Notice on Printing and Distributing the" Temporary Import Work Plan for Pharmaceuticals in Clinical Urgent Pharmaceuticals> and "stated that in order to further improve the supply of drug supply guarantees Policies to meet the people who have been listed abroad and have no supply of pharmaceutical needs of drugs that have been listed abroad and have no supplies in the country, and take this as an opportunity to form a more complete clinical urgent need for temporary imports of drugs. The Supervision and Administration Bureau has recently issued the "Plan for Clinical Urgent Pharmaceutical Importation Works" and the "Temporary Import Work Plan". Among them, the list of 50 medical institutions that lead the import and use of chinetic occupation are released.

Copystrack is a wide -spectrum antiepile seizure medicine that treats rare epilepsy, which can effectively control seizures. As of now, clotal is listed in many countries such as Britain, France, Germany and other countries. However, in China, chloropa is the second type of psychotropic drug, which is strictly controlled and has not been approved for listing.

The announcement of the scheme means that chopcatus can finally be imported, which also brings hope to the patient group. Earlier, Qilu Evening News, Qilu Yiyi published "Medicine -1042 Rare Epilepsy Brain Diseases Parents Parents Person in Public Finding Clop Copy", "This rare disease" life -saving medicine "is intended to be temporarily imported. The "Iron Horse Glacier" overseas purchasing club -chopsticks in the first instance, lawyers' innocence defense claims that it is not drug trafficking "and other reports, and continued to pay attention to rare epilepsy groups and" clotic "drugs.

Patient family: continue to wait, hope to land as soon as possible

On June 30, the reporter contacted the patient's father "Songsong Dad". "Dad Songsong" said, "The news I saw yesterday. The country gave a plan and provided our patients with a way to apply from the hospital, but it was necessary to implement it. In the end, our patients could buy medicines from the hospital. In fact, there is still a distance. "

The reporter learned that the "Cobra Zhan Temporary Import Work Plan" According to the relevant provisions of the "Plan for Clinical Expressive Drug Import", on the basis of finding out the demand for clinical drugs and medical institutional qualifications in the early stage, the chlorophara account of temporary imports were clarified The application process, drug use management, prescription physician's qualification conditions and management requirements, and relevant recipes and responsibilities are used as individual solutions for temporary imported drugs.

The patient's mother Zhang Yulan (pseudonym) also paid attention to the announcement of the plan. Her daughter's dreams were diagnosed as "nodular sclerosis" and "refractory epilepsy" when they were less than one year old. Mengmeng always cries, nods, flexes, and convulsions. The number of spasms in a day can reach 40 or fifty times. "During the attack, his eyes stared straight, his body was spasm, and it was very painful." Zhang Yulan took care of the child, just like taking care of an old man with hemiplegia.

Now Mengmeng has less than three months of chryotia. Zhang Yulan told reporters: "Many of our patients' family members want to implement them quickly and can buy medicines from nearby hospitals as soon as possible. We also hope to buy reasonably and legally."

"Now some families change medicines, and many families have broken medicine." Dad Song Song said, "Although I know that this is fast, I don’t know how long it takes to wait. You can buy medicine from the hospital. We hope to really land soon. "

Pharmaceutical company: Patients are expected to buy domestic chrysenal tablets in September

"Domestic clotal tablets have been approved to be listed, and we will not start to sell until the end of September. Our patients can really use this medicine until the end of September." Song Song's father revealed in the interview.

In December last year, according to CCTV News, the State Drug Administration stated that as of now, eight companies have been approved for the development of chopstrangine in accordance with relevant regulations. Domestic companies have not yet submitted the application for listing of chlorophastin preparations. However, two companies have submitted clinical trial applications and obtained clinical approval.

On April 12 this year, Yichang Renfang Fushain released the "Application of the Company Clotic Movie Listing Application for Acceptance" on the official WeChat public account, showing that the chine occupied by the company 10mg and 20mg submitted a listing permit for listing and smoothly went smoothly. Acceptance. On May 11, the official website of the Drug Review Center showed that Yichang Renfu's clotal Zha Zhan tablets received priority review and publicity.

Yichang Renfu pointed out that the company was approved by the development project of chopstum films in 2018 and began research and development. She declared clinical approval in November 2020, and obtained clinical approval in February 2021. The application for listing of this product was submitted to the CDE. The company will continue to follow up the process of this product to ensure its smooth listing, improve the availability of the product in the Chinese market, and better meet the health needs of the people. "

National Health and Health Commission: At least one medical institution can be selected by provinces that can use chrysenal occupation

As a rare medication, the news about clotal occupation has always affected the hearts of patients with rare epilepsy.

In July last year, the "Iron Horse Glacier" was arrested by investigators of Zhongmu County Public Security Bureau, Henan Province for buying clotal cocae overseas. Li Fang and other patients with rare epilepsy diseases were also involved in the case for helping Tiema Glacier's collection of chrysenians purchased overseas. The People's Procuratorate of Zhongmu County filed a public prosecution on the crime of smuggling, transportation, and drug trafficking; and four people including Li Fang and other four people made decisions of not prosecution.

Purchase users gradually "died and drums", and the chloroba occupied drugs in rare epilepsy groups occurred. On November 29 last year, more than 1042 rare children with epilepsy issued a letter of help- "How to let our children live? " The case of "drug dealers", "drug dealer mothers", and rare epilepsy groups once attracted attention. On March 18 this year, the "Iron Horse Glacier" purchased a case of pans and crossed the trial in the Zhongmu County People's Court. On April 15, the "Iron Horse Glacier" was taken for a bail pending trial.

On March 29 this year, the State Health and Health Commission drafted the "Temporary Import Work Plan for Clinical Urgent Pharmaceuticals" and "Caber Cycling Temporary Import Work Plan", which was disclosed to the society. In response to the needs of patients, the National Health and Health Commission proposed a list of 50 medical institutions that intend to take the introduction and use of chinenia. The announcement of such a plan has brought hope to the patient group.

On June 29, the State Drug Administration issued a notice on printing and issuing the "Temporary Import Work Plan for Clinical Urgent Pharmaceuticals" and "Caber Cabling Temporary Import Work Plan".

According to Xinhua News Agency, the relevant person in charge of the National Health Commission said that the formulation and announcement of the two programs is conducive to the stability of the problem of a small number of specific medical needs for patients. It is of great significance to guide medical institutions to regulate clinical use and ensure the safety of patients' medication. In addition, many of the drugs that need to be temporarily imported have been registered and listed abroad for many years. Therefore, it is encouraged to accelerate imitation of domestic production enterprises. At the same time, overseas drug manufacturers that are urgently needed by clinical need to actively apply for registration in China. According to the assessment of diagnosis and treatment capabilities, in order to ensure the needs of patients in various places, at least one medical institution in each province can use clotal occupation.

It is worth noting that the "Clotic Temporary Import Work Plan" clearly clarifies that each prescription must not exceed one month, and announced the list of medical institutions led by importing and using clotal. Beijing Union Hospital is the leading import hospital. Conditions for selected medical institutions include: third -level hospitals; have epilepsy sub -specialty or related professional doctors, engaged in epilepsy or children's epilepsy for more than 10 years; they have clinical and emergency plans for clinical, pharmaceutical, medical affairs, and medical affairs. Multi -disciplinary diagnosis and treatment team.

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