Dongdor was "scolded hot search"; nationwide check -up nucleic acid institutions; third -level hospitals canceled outpatient clinics

This week, a new round of outbreaks came again. On the evening of September 2nd, Chengdu's nucleic acid system collapsed. Many citizens still could not wait for nucleic acids to liner in line. Weibo -related entries "Chengdu nucleic acid system collapsed" to swipe the screen, and the nucleic acid system supplier Dong Soft was also scolded on the hot search.

Dong Soft Group issued a statement saying that after discovering the phenomenon of slowness and stuton, they checked the cause of the accident with the relevant departments of Chengdu. According to technical experts, the phenomenon such as the current system response delay and scattering have nothing to do with nucleic acid detection system software.

The eight ministries and commissions of the National Market Supervision Director, the Ministry of Public Security, and the Ministry of Natural Resources jointly caused a notice that the inspection and testing institutions were carried out across the country to carry out the "double random, one open" supervision and random inspections, and the time was scheduled to be from September to October 2022.

In terms of pharmaceutical collection, the State Drug Administration organized a promotion meeting for the selection of drug quality supervision in the collection, emphasizing the selection of drug quality supervision in the collection. At the same time, the National Medical Insurance Bureau is studying and improving the networking mechanism of the centralized pharmaceutical procurement platform to promote the establishment of a unified nationwide network and trading rules.

Cao Xuetao served as the deputy director of the National Health and Health Commission; Luo Yongqing resigned as the president of Teng Shengbo Pharmaceutical; The Jianzhi Bureau organizes more information as follows:

Heavy policy

1. Inspection agencies such as nucleic acid testing will carry out national random inspections

On September 2nd, the eight ministries and commissions of the National Market Supervision Director, the Ministry of Public Security, and the Ministry of Natural Resources jointly caused a notice that the inspection and testing institutions were carried out nationwide to carry out the "double random, one open" supervision and random inspection. From month to October.

The "Notice" states that 100 institutions will be randomly selected from the name of the national qualification identification inspection and inspection institution for supervision and random inspection, including 5 medical equipment protection products inspection and testing fields.

2. Provincial -level hanging network trading rules will be unified nationwide

The Jianzhi Bureau was informed that the National Medical Insurance Bureau was studying and improving the network -hanging mechanism of the centralized pharmaceutical procurement platform to promote the establishment of a unified nationwide network and trading rules.

In May this year, the national medical insurance information platform has been initially completed. With the normalization of the medicine collection, the web network of innovative products also needs to openly transparent and respond to the workflow of time to promote the high -quality development of the pharmaceutical industry.

According to the unified deployment, the National Medical Insurance Bureau guides all places to incorporate the eligible innovative medical consumables in the scope of medical insurance payment in accordance with the process, and determine that the DRG and DIP payment standards are determined to pay for innovative products. The next step will be optimized for the procurement rules of the network of medical collection platforms, improve the medical insurance payment policy, and provide more innovative products for the people at a reasonable price.

3. Hospital network information security requirements upgrade

On August 29, the National Health and Health Commission, the State Administration of Traditional Chinese Medicine, and the State CDC jointly issued the "Measures for the Administration of Network Security in Medical and Health Institutions".

The "Measures" require that various medical and health institutions determine the security protection level of the network in accordance with relevant standards. The new network should be carried out before the operation of the new network. The network security budget for new information projects should not be less than 5%of the total project budget.

At the same time, various medical and health institutions should determine the level of network security protection during the planning and declaration stage, and at the same time strengthen the construction of the network security notification of early warning forces, establish an emergency response mechanism, and carry out various forms of security in various forms of documentation, vulnerability scanning, and penetration tests every year. Self -check and so on.

4. The State Drug Administration increases the supervision of the collection of collection

On August 30, the State Drug Administration organized a promotion meeting for the selection of drug quality supervision in the collection of collection to re -emphasize, mobilize and deploy the selection of drug quality supervision in the collection. Huang Guo, a member of the Party Group and Deputy Director of the State Drug Administration, analyzed the quality and safety situation of the selected medicines in the current collection, and deployed the next step.

The first is: through full coverage of supervision and inspection and product random inspection, urge enterprises to continue to produce and operate in compliance, strictly control the quality of drugs, and strive to compact the responsibility of the enterprise. The second is: "one enterprise, one strategy, one product, one grade" for the selected drugs, adhere to the problem -oriented, realize the sharing of supervision information, and improve the supervision of supervision and effectiveness with informatization.

In the end, it is necessary to achieve the use of various regulatory methods, fully dispatch the supervision resources at all levels, improve cross -department collaboration mechanisms, timely identify and control risks, and form a working pattern of combining common management.

5. Third -level hospitals gradually cancel ordinary outpatient clinics

On August 30, the Hainan Provincial Government issued a notice saying that the general outpatient clinic for third -level public hospitals was gradually canceled. At the same time, the number and scale of the third -level public hospitals are strictly controlled, and the hospital hierarchical assessment is strictly controlled. Three -level public hospitals that exceed scale standards and actual needs should gradually compress the bed.

With the gradual deepening of the reform of the medical system, the national urban medical federation, the tight medical community of the county, and the gradual formation of regional medical groups, the patient's first consultation gradually tilted to the grassroots, and forced the structural adjustment of medical resources in large hospitals.

The "Notice" also clearly clearly explores the "provincial county" working mechanism between medical institutions in Hainan Province, and promotes high -quality resources such as talents, technology, and management of provincial and cities. Hospital medical services and management capabilities shortcomings.

Industry affairs

1. Chengdu nucleic acid system "collapse" storm

Chengdu originally planned to conduct a full -scale nucleic acid test from September 1st to September 4th. However, on the evening of September 2nd, the nucleic acid detection system was abnormal, resulting in the phenomenon of the sampling queue too long and the slow detection progress of nucleic acid.

The relevant person in charge immediately apologized to the people of the city of Chengdu for the first time, and said that after the failure, the professional and technical team had immediately organized the professional and technical team to investigate the reasons with the contractor and actively repaired. But there is still uncertainty and is currently working hard. As a provider of the Chengdu epidemic disease primary detection information system, Dongsoft Group issued a statement saying that after discovering the phenomenon of slow affected and stuttering, they checked the cause of the accident with the relevant departments of Chengdu. According to technical experts, the phenomenon such as the current system response delay and scattering have nothing to do with nucleic acid detection system software.

East Soft said later that after investigation, it was found that the network was faulty. After the network connection was restored, the system resumed operation again at around 14:00 on September 3.

However, the Sichuan Provincial Communications Administration immediately stated that the current communication network in Chengdu is running smoothly, the mobile network of each nucleic acid detection point is well covered, and there is no network congestion and failure.

2. Cao Xuetao served as the Deputy Director of the National Health and Health Commission

On September 2nd, the Ministry of Human Resources and Social Security released news that Cao Xuetao was appointed as the deputy director of the National Health and Health Commission, and at the same time, it eliminated the president of Nankai University.

According to public information, Cao Xuetao, born in July 1964, was from Jinan, Shandong. He graduated from the Second Military Medical University and was the director of the Institute of Immunology of the Second Military Medical University, the director of the key laboratory of the entire army's immunomotive and gene therapy, and the director of the National Key Laboratory of Medical Immunology.

In November 2015, he served as the president of the Beijing Union Medical College of the Chinese Academy of Medical Sciences; in December 2017, he served as Deputy Secretary and President of the Party Committee of Nankai University. The Jianzhi Bureau noticed that Cao Xuetao's personal introduction has appeared on the column of the "Committee Leadership" of the National Health Commission's official website and serves as the deputy director of the National Health Commission and a member of the party group.

3. Luo Yongqing resigned as the president of Teng Shengbo Pharmaceutical

On September 2nd, Teng Shengbo announced that Luo Yongqing resigned as an executive director, president and general manager of Greater China, and the chief executive of Teng Shenghua, a subsidiary of Teng Shengbo Pharmaceutical, took effect on September 15. The successor is Liang Xu, the vice president of the company's science and medical affairs.

In 2020, Luo Yongqing resigned from the position of general manager of Geely Germany Science China, joined Teng Shengbo medicine, and at the same time cooperated with the leaders Teng Shengbo and Tsinghua University and Shenzhen Third People's Hospital to develop, produce and commercialize COVID-19 antibodies in China therapy. At present, neutralized antibodies have been approved in China. The Jianzhi Bureau was informed that Luo Yongqing will join another innovative pharmaceutical company on the 19th of this month.

4. The person in charge of Ogaron China is determined

Ogaron Chief Commercial Officer Susi Fieldler and VIC Nisita, head of the global business support department, announced to employees that ZaFer University will join the global business leadership team as the head of China and officially take office on October 1.

ZAFER University is currently the head of Ogaron's global market access and trade channel department. He is a Turkish person. In 2014, he became the person in charge of the business operations of Merck's emerging market. Implement.

New drug inventory

1. Some domestic new crown pills are still developing phase III clinical

On August 31, according to Xinhua News Agency, the reporter learned from the scientific research assault team of the State Council's joint defense and control mechanism that my country actively promoted the development of new crown therapy drugs. In addition Drugs show the effect in clinical trials, and scientific and technological innovation effectively helps the epidemic prevention and control work.

These products have conducted phase III clinical trials at home and abroad. According to the relevant person in charge of the scientific research of the joint prevention and control mechanism of the State Council, the current research and development of new crown therapy drugs mainly focuses on blocking viruses into three technical routes: blocking the entering cells, inhibiting virus replication, and regulating the human immune system. my country has deployed on these technical routes.

2. Dagli Calm Treatment of Chronic Nephrology was approved in China to list in China

On September 2nd, the website of the State Drug Administration showed that the newly applied application for the listing of the new indications for the SGLT2 inhibitors of the Astraikon SGLT2 inhibitor was approved for adult patients with chronic kidney disease (CKD) with the risk of disease progress. Regardless of these patients, these patients Whether it suffers from type 2 diabetes, to reduce the continuous decline in the estimated glomerular filtration rate, progress is the end of the end -stage renal disease, cardiovascular disease death, and heart failure hospitalization. This is the most important progress of CKD treatment in more than 20 years.

Dag Line is a sodium-glucose collaboration transfer protein 2 (SGLT2) inhibitor, which was originally developed by Belief Schimibao (BMS). At present, Dagli has approved 4 adaptives in the United States, including type 2 diabetes, type 1 diabetes, HFREF (HFREF) and chronic renal diseases with reduced blood scores.

3. Laiveshabane's new indications are approved in China to list in China

On September 2nd, the website of the State Drug Administration showed that the new indications for Bayerbacon were approved to be listed to receive external arterial diseases (PAD surgery or intravascular treatment operation) ) Patients to reduce the risk of major thrombosis (cardiovascular death, myocardial infarction, ischemic stroke, major amputation and acute limb ischemia).

Livarhabane is an oral drug with high selectivity, direct inhibitory factor XA. It can inhibit the production and thrombosis formation by inhibiting factor XA and interrupting the endogenous and exogenous pathways of the coagulation waterfall. 4. Tencent AI Ophthalmology Auxiliary Diagnosis Software Listing

On August 31, the State Drug Administration issued an announcement that it approved the registration application for innovative product registration of "Chronic glaucoma -like neuropathy image assist diagnostic software" produced by Tencent Medical Health (Shenzhen) Co., Ltd.

This product is an adult patient who needs to be taken through the bottom of the eye to determine whether there is a risk of disease. The test results are for doctors for reference. It should be noted that this product is not suitable for high myopia people.

5. Shenzhou cell anti -CD20 monoclonal anti -resistance approval

On August 30, the website of the State Drug Administration announced that the listing application of the Ruipusab submitted by Shenzhou cells has been approved, which is suitable for the new diagnosis of CD20 positive large B cellular non -Hodgkin lymphoma (DLBCL) adult patient.

As of now, the CD20 antibody drugs that have been approved by China are: Roche Merohua, Jialuohua, and Dabohua of Cinda Bio and Hanliku of Fuxing Hanyin. Both domestic drugs are similar medicines for Merohua. According to the IQVIA database, in 2021, the sales of CD20 antibodies in China were about RMB 3.156 billion.

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