Here comes the management method of national drug shortage list! 2 cases can be called out

Wen Feng mound On January 15, the State Department of Drug Administration issued the measures for the administration of the list of drugs in short supply (Trial) (Draft for comments) for public comments According to the requirements of the drug administration law of the people's Republic of China and the opinions of the general office of the State Council on further ensuring the supply and price stability of drugs in short supply, the State implements the list management system of drugs in short supply In the new drug administration law officially implemented on December 1, there are four articles related to the shortage of drugs: There are 14 articles in the draft of the measures for the administration of the list of drugs in short supply (for Trial Implementation): Articles 1 to 4 clearly define the basis for the formulation of these measures, the definition of drugs in short supply and easily needed drugs for clinical use, the scope of application and the main body of formulation of these measures; Articles 5 to 9 define the formulation principles and procedures of the national list of drugs in short supply and the key monitoring list of drugs easy to be short in clinical use, including the key links such as the formation of the basic list, expert argumentation, organization of review, examination and release, etc; Article 10 defines the principle of transferring out the list of drugs in short supply; Article 11 defines the purchase policy and price supervision policy of drugs included in the national list of drugs in short supply and the key monitoring list of clinically necessary drugs in short supply; Articles 12 to 14 are the relevant supplementary articles The management measures emphasize that 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 Medical institutions can propose purchase demands, search for drug manufacturers offline, negotiate with drug suppliers directly, negotiate and determine purchase prices in accordance with the principle of fairness, and independently file in the provincial drug centralized purchase platform to achieve openness and transparency In terms of transfer out, the methods also clearly stipulate that: those with sufficient market supply, able to form effective competition and basically meet the clinical needs; those that can be replaced by new varieties with better risk-benefit ratio or cost-benefit ratio It should be transferred from the national list of shortages of medicines: The specific contents of the measures are as follows: Measures for the administration of the list of drugs in short supply of the state (for Trial Implementation) (Draft for comments) 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 Article 13 the leading unit of the national linkage mechanism shall be responsible for the interpretation of these measures.