The national health and Health Commission issued a document that these drugs were named for key monitoring

Finishing: Ania The national health and Health Commission issued a document, and these drugs were named for key monitoring On January 15, the drug administration department of the national health and Health Commission issued a document on the public solicitation of opinions on the measures for the administration of the list of drugs in short supply (Trial) (Draft for comments) According to the announcement, in the future, the National Health Commission, together with the member units of the linkage mechanism, will work out the national list of drugs in short supply and the key monitoring list of clinically necessary drugs in short supply, and establish a dynamic adjustment mechanism In order to strengthen the early warning of the risk of drug shortage, the state focuses on the monitoring of clinically necessary and easily short drugs Among them, drug shortage refers to the drug that is approved by the drug regulatory department of China to be on the market, clinically necessary, irreplaceable or not completely replaceable, and in a certain period of time or in a certain region in short supply or unstable The drugs that are easy to be short of clinical necessity refer to the drugs that are approved to be listed by the drug supervision and Administration Department of our country, which are clinically necessary, irreplaceable or not completely replaceable, have few sources of supply and risk of supply shortage, and focus on the basic drugs and drugs for emergency (emergency) rescue, major diseases, public health and special population The State shall organize the formulation of the national list of drugs in short supply and the list of key monitoring of clinically necessary drugs in short supply After the corresponding list is established, a new batch of drugs will be included in the scope of key monitoring The document is clear, and the national health and Health Commission is clear about the Department responsible for monitoring the shortage of drugs, and comprehensively analyzes the monitoring information of the multi-source information collection platform for the shortage of drugs and the information shared by the departments In principle, in the same period, three or more provincial drug shortage lists are included, and the provincial linkage mechanism can not effectively solve the shortage of drugs in a certain period of time through direct online, independent filing and drug storage, forming the national basic list of short drugs Based on the comprehensive analysis of the following information, a list is formed: （1） Drugs included in the key monitoring list of clinically necessary and vulnerable drugs at the provincial level; （2） Information on the shortage of drugs reported at the provincial level; （3） Monitoring information of national multi-source information collection platform for drug shortage; （4） Department Unicom sharing information; （5） Information on the use of essential drugs, emergency (rescue), major diseases, public health, special population, etc with small number of production enterprises, small clinical demand and uncertainty The varieties that belong to one of the following circumstances shall be transferred from the list of national shortages of medicines （1） The market supply is sufficient, the effective competition can be formed, and the clinical demand can be basically met; （2） It can be replaced by new varieties with better risk-benefit ratio or cost-benefit ratio For the varieties in the national and provincial list of drugs in short supply, enterprises are allowed to quote independently on the provincial drug centralized purchase platform, directly hang the network, and medical institutions are allowed to purchase independently For the drugs in the key monitoring list and the list of drugs in short supply, if there is no enterprise on the provincial drug centralized purchase platform or they are not listed in the provincial centralized purchase directory, the medical institutions can put forward the purchase demand, search for the drug manufacturers offline, negotiate with the drug suppliers directly, negotiate and determine the purchase price according to the principle of fairness, and then select the drugs at the provincial level The centralized procurement platform shall record independently and be open and transparent In addition, the state will strengthen the monitoring and early warning of abnormal prices of drugs in the list of drugs in short supply and the list of drugs that are easy to be short in clinical use, strengthen the supervision of price normalization, strengthen the enforcement of law on illegal acts such as monopoly of APIs, and properly deal with the problem of too fast rise of drug prices by classification According to relevant reports, from January to may 2018, according to the sorting out of the data in the "short drug monitoring results express and annex", there are nearly 2000 short drugs involved in the national public hospitals' short drug monitoring posts, while the number of short drugs involved in the same period in 2017 is only 860 Up to now, including Ningxia, Guizhou, Yunnan, Jiangsu, Inner Mongolia and other provinces have issued a list of medicines in short supply 30 provinces have established consultation linkage mechanism, identified more than 500 monitoring outposts for drug shortage, sorted out the list of 139 clinical vulnerable drugs, most of which have resumed production and supply; strengthened the analysis, processing and reporting of shortage information, and solved the supply problem of more than 100 drugs, such as penicillamine, protamine and Herceptin At the same time, the centralized production and stable supply of 20 kinds of short drugs are realized through the layout of the centralized production base of small drugs (short drugs) Nowadays, the shortage of drugs has risen to the national level, which is highly valued On October 11, 2019, the general office of the State Council issued the opinions on further ensuring the supply and price stability of drugs in short supply (hereinafter referred to as the opinions) According to the opinions, the distribution of drugs in short supply shall not be restricted by the distribution enterprises, and shall not be restricted by the "two ticket system" and other measures For a long time, low distribution rate and difficult distribution have been the pain points of drug shortage, and "low-cost drugs, winning the bid" also makes many enterprises have to give up drug production, so that the drug supply is insufficient This time, the national health and Health Commission again stressed that the shortage of drugs may further accelerate the process of solving the problem Article 1 in order to strengthen the national supply guarantee of drugs in short supply, establish and improve the management system of the list of drugs in short supply, these measures are formulated in accordance with the provisions of the drug administration law of the people's Republic of China and the requirements of the opinions of the general office of the State Council on further ensuring the supply and price stability of drugs in short supply (GBF [2019] No 47) Article 2 the term "drugs in short supply" as mentioned in these Measures refers to the drugs that are approved to be listed by the drug regulatory department of China, which are clinically necessary, irreplaceable or not completely replaceable, and are in short supply or unstable supply within a certain period of time or region In order to strengthen the early warning of the risk of drug shortage, the state focuses on the monitoring of clinically necessary and easily short drugs The drugs that are easy to be short of clinical necessity refer to the drugs that are approved to be listed by the drug supervision and Administration Department of our country, which are clinically necessary, irreplaceable or not completely replaceable, have few sources of supply and risk of supply shortage, and focus on the basic drugs and drugs for emergency (emergency) rescue, major diseases, public health and special population The State shall organize the formulation of the national list of drugs in short supply and the key monitoring list of drugs that are easily needed in clinical use Article 3 these measures are applicable to the determination, issuance and adjustment of the national list of drugs in short supply and the key monitoring list of drugs that are easily needed in clinical use Article 4 the national health and Health Commission, in consultation with the member units of the linkage mechanism (hereinafter referred to as the linkage mechanism) of the national shortage drug supply guarantee work, shall formulate the list of national shortage drugs and the key monitoring list of clinically necessary and vulnerable drugs, and establish a dynamic adjustment mechanism Article 5 the formulation and adjustment of the national list of drugs in short supply and the key monitoring list of drugs easily in short supply for clinical use shall be guided by the guarantee of clinical demand and adhere to the principles of scientific prudence, graded response and linkage between the top and the bottom Sixth article The national health and Health Commission has made clear the Department responsible for the monitoring of the shortage of drugs, comprehensively analyzed the monitoring information of the multi-source information collection platform for the shortage of drugs and the information shared by the departments In principle, the three or more provincial list of the shortage of drugs are included in the same period The provincial linkage mechanism can not effectively solve the shortage problem in a certain period of time by means of direct network, independent filing and drug storage The basic list of drugs in short supply of the State shall be formed According to the comprehensive analysis of the following information, the departments of the national health and Health Commission responsible for the monitoring of drugs in short supply form a list of the key monitoring bases of drugs that are necessary for clinical use in China: （1） Drugs included in the key monitoring list of clinically necessary and vulnerable drugs at the provincial level; （2） Information on the shortage of drugs reported at the provincial level; （3） Monitoring information of national multi-source information collection platform for drug shortage; （4） Department Unicom sharing information; （5） Information on the use of essential drugs, emergency (rescue), major diseases, public health, special population, etc with small number of production enterprises, small clinical demand and uncertainty Seventh article The national health and Health Commission is responsible for the establishment of an expert database for the management of the national list of drugs in short supply, which is composed of experts in clinical medicine, pharmacy, public health, traditional Chinese medicine, pharmacoeconomics, law, etc it is responsible for the demonstration of the clinical necessity and substitutability of drugs in the national list of basic drugs in short supply and the list of key monitoring bases of drugs in short supply, and the formation of recommendations Detailed list Article 8 the national health and Health Commission, together with the relevant departments, shall organize the review of the inventory, purchase, distribution and the reasons for the shortage of drugs in the national list of recommended drugs for shortage according to their responsibilities, and conduct joint investigation if necessary, and propose the national list of drugs for shortage to the member units of the linkage mechanism for review according to the results of the investigation and review The national health and Health Commission puts forward the national key monitoring list of clinically necessary and vulnerable drugs to be sent to the member units of the linkage mechanism for review, and may investigate and review with relevant departments if necessary The above investigation and review work can be entrusted to the leading unit of provincial linkage mechanism to coordinate and organize, and give full play to the role of pharmaceutical industry academic (Association) association Article 9 the national list of drugs in short supply and the key monitoring list of drugs in short supply for clinical use shall be issued by the leading unit of the national linkage mechanism (the national health and Health Commission) after being reviewed by the member units of the linkage mechanism The tenth species that belong to one of the following situations shall be transferred from the list of national shortages of medicines: （1） The market supply is sufficient, the effective competition can be formed, and the clinical demand can be basically met; （2） It can be replaced by new varieties with better risk-benefit ratio or cost-benefit ratio Article 11 for the varieties in the national and provincial drug shortage list, enterprises are allowed to quote independently on the provincial drug centralized purchase platform, directly hang the network, and medical institutions are allowed to purchase independently For the drugs in the key monitoring list and the list of drugs in short supply, if there is no enterprise on the provincial drug centralized purchase platform or they are not listed in the provincial centralized purchase directory, the medical institutions can put forward the purchase demand, search for the drug manufacturers offline, negotiate with the drug suppliers directly, negotiate and determine the purchase price according to the principle of fairness, and then select the drugs at the provincial level The centralized procurement platform shall record independently and be open and transparent The state will strengthen the monitoring and early warning of abnormal prices of drugs in the list of drugs in short supply and the list of drugs that are easy to be short in clinical use, strengthen the regulation of price normalization, strengthen the enforcement of law on illegal acts such as monopoly of raw materials drugs, and properly deal with the problem of too fast rise of drug prices by classification Article 12 the management of the list of drugs in short supply in the army and at the provincial level and the list of key monitoring drugs that are easily needed for clinical use shall be formulated with reference to these measures.