Exclusive interpretation: over duplication of drugs in "severely affected areas"

In order to open the information, guide the registration and application policies of pharmaceutical enterprises, and reduce the waste of resources, CFDA issued the list of over repeated drugs for two consecutive years What will happen in the future for the over repeated drug list? For this reason, the author analyzes and interprets the varieties of the two lists Comparison of two batches of catalogues: increase and decrease of varieties and inclusion conditions CFDA issued the list of over repeated drugs for two consecutive years In September 2016, CFDA screened 282 over repeated varieties in the first batch according to the drugs that had been on the market from 2012 to 2014, with more than 20 enterprises with approved number and more than 20 enterprises with approval number on sale as the screening conditions
In June 2017, CFDA once again monitored and analyzed the sales of approved drugs between 2013 and 2015 According to the conditions that the number of enterprises with approved number ≥ 20 and the number of enterprises with approval number in three years monitored by cmei, or the number of enterprises with approval number ≥ 20 and the number of enterprises with approval number in three years monitored by RDM, CFDA once again monitored and analyzed the sales of approved drugs between 2013 and 2015 294 varieties were selected from more than 20 varieties According to the CFDA announcement, "compared with the drug list issued in Announcement No 153rd of 2016, 13 new varieties were added, and 1 varieties were transferred from the original catalogue." The product kicked out was andrographolide Compound aminopyrine was also not included in the 2017 catalog, but aminopyrine caffeine was included in the 2016 and 2017 catalogs, and CFDA is expected to combine the two The new varieties include cefdixone sodium, clozapine, mycophenolate mofetil, sulpiride, acarubin powder, urea vitamin E, compound beclomethasone camphor, Compound Gentamycin, cefpodoxime mofetil, oxaliplatin, transfer factor, phenytoin sodium and penicillin G sodium Hospital channel analysis: the most fierce sample hospital procurement data of injection competition (cmei) covers more than 1000 hospitals in 31 provinces (districts and cities) in China It can be seen from the data of cmei sample hospitals monitoring the number of enterprises with common names in three years that antibiotics and nutrition products are the main products sold by hospitals at present, and most of the common dosage forms of common name products in hospitals are injections Since 2016, provinces have begun to formulate the policy that antimicrobial injections should not be used in outpatient clinics In addition, many provinces require one bid winning enterprise with a common name - dosage form - Specification, which will greatly reduce the number of enterprises whose products are circulated in hospitals The last year of this data statistics is 2015 The data has certain lag, which may not reflect the impact on product competition under the influence of recent policies Comparing the number of common name enterprises monitored by cmei for three years, we found that the number of enterprises in omeprazole dropped the most, from 147 to 82, a total of 65 The second was norfloxacin, down from 144 to 133, down only 11 The largest increase in the number of enterprises was lansoprazole, from 37 to 43 In May 2017, CFDA asked for opinions on relevant policies on encouraging innovation of pharmaceutical medical devices to implement full life cycle management of pharmaceutical medical devices (Draft for comments), which mentioned to carry out re evaluation of marketed injections According to the relevant provisions of the drug administration law, it is necessary to reevaluate the safety, effectiveness and quality controllability of the approved injection according to the scientific progress of the injection drugs CFDA plans to basically complete the re evaluation of the marketed injection within 5-10 years Through the re evaluation of the products, we can enjoy the relevant policies of the consistency evaluation of the quality and efficacy of the chemical generic oral solid preparations After the implementation of this policy, it is expected that the injection approval in the current over repeated drugs will face a reshuffle Cmei monitoring the number of enterprises with common name in three years ranking the number of enterprises with common name corresponding to the second directory number of enterprises with common name corresponding to the first directory number of enterprises with common name corresponding to the first directory 1 metronidazole 205 metronidazole 206 2 glucose 183 glucose 188 3 vitamin C 178 sodium chloride 181 4 ribavirin 175 vitamin C 179 5 Levofloxacin 174 levofloxacin 179 6 sodium chloride 172 Ribavirin 170 7 azithromycin 162 azithromycin 170 8 vitamin B6 142 vitamin B6 152 9 Norfloxacin 133 omeprazole sodium 147 10 vitamin b1131 Norfloxacin 144 11 sodium bicarbonate 117 vitamin B1 135 12 acyclovir 116 clindamycin 122 13 clindamycin 114 sodium bicarbonate 115 14 gentamicin 108 acyclovir 114 15 fluconazole 107 mannitol 112 16 Inosine 104 fluconazole 110 17 mannitol 102 Inosine 108 18 glucose sodium chloride 101 glucose sodium chloride 107 19 ranitidine 101 gentamicin 107 20 paracetamol 101 paracetamol 102 (data source: sensitive information) retail channel analysis: 289 category cluster competition The purchase data of sample drugstores are from RDM of CFDA Southern pharmaceutical Economic Research Institute, and the samples are from 6200 sample drugstores in 65 cities in China In terms of the number of enterprises with approval number of sample drugstores (RDM) monitoring for three years, currently, the competitive products of drugstores are mainly antibiotics and cold medicine products, and most of the products are in 289 oral medicine directories that need to complete the consistency evaluation by the end of 2018 Comparing the number of generic enterprises in the first and second RDM of China's drug retail market for three years, we found that the decline of the number of enterprises of compound paracetamol and amantadine was the largest, from 230 to 189, followed by roxithromycin, from 177 to 141, and amlodipine was the third, from 83 to 61 Compound paracetamol, compound paracetamol, amoxicillin and diclofenac sodium are the products with a large increase in the number of enterprises, which may be related to the number of the first catalog monitoring Since 2015, the registration reform of drugs is not only aimed at unlisted products, but also includes the re evaluation of the listed approvals At present, pharmacies are faced with the evaluation of consistency of products on sale, but