An announcement by the General Administration on the publication of information on excessively repeated drug tips

In order to accurately reflect the supply and demand dynamics of China's drug market, scientifically guide drug research and development institutions and enterprises to conduct orderly research and development and rational declaration, to avoid low-level duplication and waste of resources, in accordance with the State Council on the reform of the drug medical device review and approval system (Guofa (2015) No. 44) and "on the drug registration review and approval of a number of policies" (State Food and Drug Administration Announcement No. 230 of 2015) requirements, the State Food and Drug Administration of 2012-2 In 2014, the listed drug situation has been combed, according to the number of approved enterprises more than 20 and the number of enterprises in the sale of approval number more than 20 as a screening criteria, a total of 282 over-repeated varieties (in general name, the same below), is now published, and the relevant matters announced as follows:
1, statistics from the sample hospitals and sample pharmacies procurement data and drug registration approval number data comprehensive analysis. Among them, there are registered approval number drug data from the State Food and Drug Administration Information Center, sample hospital procurement data from the National Pharmaceutical Economic Information Network (CMEI) covering the country's 31 provinces (regions, cities) more than a thousand hospitals, sample pharmacy procurement data from the State Food and Drug Administration Of the Southern Pharmaceutical Economic Research Institute of China Drug Retail Market Drug Analysis System (RDM), samples from 65 cities, 6,200 sample pharmacies.
II. The drugs monitored and counted cover a total of 2,750 generic varieties (excluding Chinese medicine and raw materials without preparation approval) approved for listing by the State Administration of Food and Drug Administration before November 25, 2014. Medicines, vaccines and in-body diagnostic reagents, involving approximately 110,000 registered approved products, and 14 major categories and 99 subclasses involving the Anatomical, Therapeutic and Chemical Classification (ATC) classification of drugs. Of these, 438 varieties have not been recorded for sale in both CMEI and RDM databases in the past three years.
3. Through the analysis of drug sales and use in sample hospitals over the past three years, a total of 2241 varieties are currently in normal circulation, of which 21 varieties have more than 100 production enterprises products listed for circulation, 70 varieties have 50-99 production enterprises products on the market circulation. It shows that there is a serious problem of over-duplication of some drugs used in normal circulation.
4. Through the data analysis of the sales amount and usage of the same variety in the sample hospital for 3 years (less than 10 all statistics), the sales amount of the top 10 varieties, their total sales exceed 90% of the total sales amount of this variety. 2088 (93.17 per cent of the total); Explain that the same variety has 10 enterprises production and sales can basically meet market demand.
5, monitoring data show that according to the ATC classification, the top 8 drug categories are: digestive and metabolic drugs, nervous system drugs, systemic anti-infective drugs, respiratory drugs, cardiovascular drugs, dermatological drugs, anti-tumor and immunomodulators, blood and hema production system drugs, these eight drugs involved a total of 2227 varieties, accounting for 80.98% of all monitored varieties.
State Administration of Food and Drug Administration reminded relevant pharmaceutical manufacturers and research and development institutions to fully understand the market supply and demand situation, scientific assessment of drug research and development risks, prudent investment and management decisions. The food and drug supervision and administration departments of the provinces, autonomous regions and municipalities directly under the Central Government shall strengthen the examination and examination of applications for registration of related drugs, carry out on-site verification of research and development and on-site inspection of production, take the initiative to do a good job of publicity on the over-repeated drug varieties that have been published, and guide enterprises to rational research and development and declaration.
this announcement. (State Administration of Food and Drug Administration)