The Pharmaceutical Supervision Bureau investigated and dealt with the collection of varieties, and the multinational pharmaceutical company apologized

There are problems with the heavy varieties of multinational pharmaceutical companies.

On August 24th, the State Drug Administration issued an announcement saying that recently conducted an overseas non -on -site examination of UCBs (UCB) and found that the validity period and registration approval of some batches of some batches of solutions used in Zuo Yican injection The validity period is inconsistent.

The State Drug Administration issued a conclusion that the production of the company Zuo Yiraistein injection in the company did not meet the requirements of China's "Drug Production Quality Management Specification (Revised in 2010)" (ie GMP). From now on, the product has been suspended from importing, selling and use in China, and investigations are investigated in accordance with the law.

The company involved in the agent of You Ji Bi Jianzhi said that the incident was caused by the effective logo error on the four specific batch packaging of Zuo Yiraistein injection. As of August 24, 2022, the above -mentioned products were registered and approved in China on August 24th, and the safety risks of affected batches were not monitored.

In 2020, Zuo Yican injection was included in the third batch of national collection. Chongqing St. Huaxi Medicine, Hainan Pribei, You Jibi, and Hebei Renhe Yikang won the bid. However, according to the collection documents of the year, the procurement cycle of this variety was only one year in principle. One year later, the contract was organized by the provinces by themselves. There are not many provinces in which the product is actually supplied than the product.

The Jianzhi Bureau was informed that the active recall of the investigation and the involved in the investigation and the involved were currently launched, and targeted rectification measures were adopted in order to restore the supply of the drug in the Chinese market as soon as possible. Sorry for this off -confession incident.

According to data from the State Drug Administration, there are as many as 18 manufacturing enterprises using strong solutions in Zuo Yizyan, of which there are many domestic well -known domestic pharmaceutical companies such as Jichuan Pharmaceutical, Zhejiang Zhenyuan, Yangzijiang, and Huahai. Clinical use should be guaranteed.

It is no longer a national collection variety, which is guaranteed in clinical use

Zuo Yiracatin injection is a special effect of treating epilepsy (accompanied by a comprehensive seizure of secondary comprehensive seizures). In March and August 2006, it was listed in the European Union and the United States. In March 2010, You Jibi's drug was listed in China, and the product was called "Kai Pulan".

With the deepening of population aging and many factors such as the incidence of brain diseases, it is conservatively estimated that there are about 90 million patients in China at present, and new cases of 400,000 will occur each year. From the perspective of most industries, epilepsy drugs, as a regular treatment of neurosurgery, huge clinical needs will undoubtedly drive the clinical use of thick solutions for Zuo Yican injection.

In 2020, Zuo Yican injection was included in the third batch of national collection. However, because it was an injection, it was the first time that the national collection was included in the dosage form. Therefore, the procurement cycle set by the Medical Insurance Bureau was one year, and one year later, it was renewed by various places according to the implementation situation.

A person close to the State Medical Insurance Bureau told the Jianzhi Bureau: Zuo Yiraistein's injection has exceeded the label period, and the procurement contract has ended. At the legal level, the drug -edge of this drug and the national collection of the country have already been recruited. It doesn't matter.

However, there are also heads of the government affairs department of multinational pharmaceutical companies that the national collection of expires will be transferred to the localities to continue the collection. In principle, the report of the medical institution cannot be lower than the national collection. Automatically change to provincial level.

This "Kai Pulan" was decided by the National Drug Administration to suspend import, sales and use, and the supply and use of the corresponding province may be affected. Whether you can enter the provincial -level collection in the future will not be concluded.

In the context of the reform of "patient -centric", the quality of drugs is undoubtedly the red line of the regulatory authorities. From the research and development, production, distribution, use and other guarantee mechanisms and supporting policies, it can be improved and optimized. In the future, Chinese patients can take rest assured medicine in the future.

The market shuffling is tending to be, and the quality cannot be "discounted"

In February of this year, Chen Jinfu, deputy director of the National Medical Insurance Bureau, made it clear that by the end of 2022, it would achieve an average of 350 varieties covered with the average province through national organizations and provincial alliance procurement.

In fact, as the collection enters the normalization, the quality of drugs is more concerned, and the supervision methods of medical insurance and drug supervision departments are becoming more and more effective.

In June 2022, Shanghai Pharmaceutical Sunshine Procurement Network issued an announcement saying that the Indian Sun Company did not meet the imported drug registration standards due to some batch of products "dry weight" project, and was suspended, suspended, recalled, etc. After the risk control, after notifying, it also eligible for the selection of its national collection.

Not only the national collection, but also local provincial -level collection of quality supervision as a key task to investigate any hidden safety hazards.

In July 2022, the Heilongjiang Provincial Pharmaceutical Bureau issued an announcement that medical institutions in the province found that there were visible foreign bodies produced in the 250ml glucose injection product produced by Qitaihe Pharmaceutical Factory in Heilongjiang Province, and decided to start the province's drug emergencies level 4 emergency response , Immediately remove the related products and wait for the recall and stop using it in clinical.

In January 2022, the Guizhou Provincial Pharmaceutical Bureau suspended the production and sales of the second batch of products in the second batch of products in the selected products in the selected products. The reason is that flight inspections have found that it has serious defects in the maintenance of plant maintenance, equipment cleaning, and stability inspection, and does not meet the quality management specifications of drug production.

Up to now, Jiangxi, Hubei, Shandong, Anhui, Ningxia, Shaanxi and other provinces have actively promoted special check -up in the selection of drug production in centralized band procurement in 2022, and issued related work plans and notices to strengthen quality and safety supervision.Ensure the safety of the public's medication and effectively ensure the safety and effectiveness of the people's medication.The State Medical Insurance Bureau has established a credit evaluation system. If any illegal situation in pharmaceutical companies will be included in the "illegal list", it has suspended the company's collection qualification for a period of time, and has suffered severe punishment for losing the market.

In the industry's views, for enterprises, although the collection of drugs has compressed profits, it cannot sacrifice the quality of drugs as a price to pursue corporate growth.If you step on the bottom line, you will suffer a regulatory punch.

Writing ｜ Lei Gong

Edit ｜ Jiang Yun Jia Ting

Operation | Valley

Illustration | Visual China

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