Medical network, June 8, in order to pass the information of the public, guiding drug firms registered declare policy, reduce resource waste, after two years of release excessive CFDA repeat drug list. What will be the future of the over-duplicated drug list? In this paper, the author analyzes and interprets the varieties of the two lists. 

 

Two batch directory comparisons: 

 

The variation of varieties and conditions of inclusion 

 

The CFDA has issued a two-year list of over-duplicated drugs. 

 

In September 2016, the CFDA according to drugs already on the market from 2012 to 2014, in order to have approval number more than 20 companies and in the approval document for the pin companies more than 20 as the filter condition, selected the first batch of 282 varieties of excessive repetition. 

 

In June 2017, the CFDA again has approved the sales situation of listed drugs from 2013 to 2015, monitoring analysis according to conform to have formed an approval number 20 or more, and the sample hospitals (CMEI) monitoring in 3 years sales companies of 20 or more conditions, an approval number or meet has won approval number formed 20 or more, and sample pharmacy (RDM) monitoring for 3 years in the number of the approval document for the pin companies of 20 or more conditions of generic varieties selection, a total of 294 varieties selected. 

 

According to the CFDA announcement, "13 new varieties have been added to the list of 13 new varieties, compared with the list released in 2016," according to the CFDA. The product that is said to be kicked out is the heart of the heart. The compound is not in the 2017 catalog, but it is expected that the CFDA will combine the two in the 2016 and 2017 catalogs. 

 

New varieties of cefazolin sodium lamictal, clozapine, it for 7 phenol ester, sulpiride, o cafe of phenol, urea, vitamin E, compound of beclomethasone dipropionate mooring oxime esters, camphor, compound gentamycin, cephalosporins, transfer factor and oxaliplatin into and penicillin G sodium phenytoin sodium. 

 

Hospital channel analysis: 

 

Injectable drugs are the most competitive 

 

Sample hospital procurement data (national pharmaceutical economic information network, CMEI) covers more than 1000 hospitals in 31 provinces (districts, cities) of the country. Hospital monitoring for 3 years from CMEI samples of generic companies ranked data can be seen that the current hospital more competitive in the sales of products is given priority to with antibiotics, nutritional products, and most of generic products commonly used dosage forms is injection in the hospital. 

 

Since 2016, the province began to antimicrobial drugs should not be used in outpatient injection policy, in addition many provinces demanding a common name - dosage forms - specifications of the bidding for a enterprise, it will greatly reduce the product circulation of companies in a hospital. The last year of the data is 2015, with a certain lag in data that does not necessarily reflect the impact of recent policies on product competition. 

 

General sensitive information comparing the first and second catalog samples hospital (CMEI) monitor 3 years of generic companies found that companies of omeprazole biggest drop in, decreased from 147 to 82, total 65. The second is norfloxacin, which dropped from 144 to 133, dropping only 11. The increase in the number of products with the largest number of businesses is landsorazole, from 37 to 43. 

 

In May 2017, the CFDA about asking about encouraging drugs medical equipment innovation implementation drugs in whole life cycle of medical instrument management policies "(draft) opinion, mentioned in the listed injection evaluation again. Pharmaceutical administration in accordance with the relevant provisions, need according to the injection drug scientific progress, to have approved injection safety, efficacy and quality control and evaluation. The CFDA plans to complete the reevaluation of the listed injection for 5-10 years. The policy of the evaluation of the quality of the solid preparation and the consistency of the effectiveness of the treatment of the chemical generics was received through the reevaluation of the products. After the implementation of the policy, the current injections of injectable drugs are expected to be reshuffled. 

 

CMEI monitors three years of gm rankings 

排名	第二次目录通用名	对应企业数	第一次目录通用名	对应企业数
1	甲硝唑	205	甲硝唑	206
2	葡萄糖	183	葡萄糖	188
3	维生素C	178	氯化钠	181
4	利巴韦林	175	维生素C	179
5	左氧氟沙星	174	左氧氟沙星	179
6	氯化钠	172	利巴韦林	170
7	阿奇霉素	162	阿奇霉素	170
8	维生素B6	142	维生素B6	152
9	诺氟沙星	133	奥美拉唑钠	147
10	维生素B1	131	诺氟沙星	144
11	碳酸氢钠	117	维生素B1	135
12	阿昔洛韦	116	克林霉素	122
13	克林霉素	114	碳酸氢钠	115
14	庆大霉素	108	阿昔洛韦	114
15	氟康唑	107	甘露醇	112
16	肌苷	104	氟康唑	110
17	甘露醇	102	肌苷	108
18	葡萄糖氯化钠	101	葡萄糖氯化钠	107
19	雷尼替丁	101	庆大霉素	107
20	对乙酰氨基酚	101	对乙酰氨基酚	102

　(source: sensitive information) 

 

Retail channel analysis: 

 

289 catalog varieties compete with each other 

 

Sample pharmacy purchasing data from the CFDA south medicine retail market economic research institute, Chinese medication analysis system (RDM), samples from the country's 65 city, 6200 samples of drugstore. Samples from pharmacy (RDM) monitoring for 3 years in the number of the approval document for the pin companies, pharmacies in more competitive products with antibiotics and cold medicine products, and most of the products need to be completed by the end of the first batch of 2018 289 for oral administration of consistency evaluation directory. 

 

General sensitive information is the first and second directory Chinese drug retailing market analysis system (RDM) monitor 3 years of generic companies found that compound acetaminophen of alkyl amine formed the biggest drop in, decreased from 230 to 189; Followed by roerythromycin, down from 177 to 141; Aminoclodipine third, down from 83 to 61. Compound acetaminophen that sensitive, compound paracetamol, amoxicillin and diclofenac sodium is companies grow larger products, this may be related to the first directory monitoring number. 

 

Since 2015, the reform of drug registration has been aimed at more than just unlisted products, including reappraisal of approved approvals. Facing the current pharmacy in pin products for oral administration policy consistency evaluation, but the country does not pass the consistency evaluation of drug market access is still mainly ban hospital level, rather than pharmacies. From China's food and drug verification research institute of generic drugs quality consistency evaluation office announced record information and has to carry out the bioequivalence trial products, these repeated declare product enterprises are willing to invest little consistency evaluation, these products in the future will choose to leave the hospital in a pharmacy market, can often stay in the hospital market is Europe and the United States has also launched the imported products. 

 

RDM monitors three years of gm rankings 

排名	第二次目录通用名	对应企业数	第一次目录通用名	对应企业数
1	阿奇霉素	202	复方氨酚烷胺	230
2	诺氟沙星	202	诺氟沙星	209
3	左氧氟沙星	195	阿奇霉素	209
4	复方氨酚烷胺	189	左氧氟沙星	203
5	复方氨酚那敏	186	罗红霉素	177
6	复方对乙酰氨基酚	173	甲硝唑	140
7	甲硝唑	149	利巴韦林	132
8	罗红霉素	141	头孢拉定	121
9	利巴韦林	131	头孢氨苄	112
10	头孢拉定	128	氧氟沙星	106
11	对乙酰氨基酚	121	维生素C	106
12	阿莫西林	117	阿昔洛韦	103
13	头孢氨苄	112	二甲双胍	98
14	双氯芬酸钠	110	对乙酰氨基酚	92
15	阿昔洛韦	103	布洛芬	87
16	氧氟沙星	99	克拉霉素	87
17	维生素C	92	雷尼替丁	85
18	克林霉素	92	氟康唑	84
19	二甲双胍	91	氨氯地平	83
20	奥美拉唑	90	替硝唑	81

　　(source: sensitive information) 

 

Think about 

 

How big is the reshuffle effect? 

 

In February 2017, the administration of the general office of inviting public announcements about drugs registration related matters (draft) "mentioned in the opinion, in the drug approval documents shall specify the period of validity, the all products specifications are not listed or import drug, cannot perform continuous responsibility of quality, efficacy and adverse drug reaction, since the date of this announcement, the drug will not be registered again, approval number (the imported drug registration certificate" the pharmaceutical products registration certificate) will be cancelled after the expiration. The notice has been collected for comment on April 13, 2017 and has not yet been released. 

 

In the announcement of the 2016 overstatement, there were only 438 varieties of CMEI and RDM in the past three years. In 2017, the announcement of an over-repeated drug message was not disclosed. The number of unrecorded varieties is not much higher than the current number of 18,461 and about 170,000. 

 

Drugs registration of fixed number of year is usually five years, there have been four years from 2012 to 2015 data, the CFDA could not currently selling products in 2018 will not be registered again, but in 2016 the first batch of excessive repeated drug monitoring results, the policy is expected to reshuffle the product quantity is not as imagination of so many. 

 

Small knot 

 

CFDA release excessive repeated drug list is to make information public, guiding drug firms registered declare policy, reduce the waste of resources, the direction is worth encouraging. 

 

However, if the administration measures to restrict the filing of the drug companies, it creates competition barriers for the manufacturers who have received the approval. The profit and loss should be made by the production enterprise itself. When the market price competition is too fierce, naturally the manufacturer exits the competition, let the price return reasonable. The combination of the oral administration and the evaluation of the injection and the evaluation of the injection will be sufficient to eliminate the substandard manufacturers. 

 

Past medical institutions bidding policy, is refers to the lowest bid, enterprise product quality and the lowest bid does not conform to the drugs were for listing standards. The paradox is that there is no life cycle management for the listed drugs, so that products that fail to pass through quality can also flow through the channels. Over the past two years, CFDA's flight reviews and process checks have shown a shift in the way the CFDA is managed to closely monitor the quality of listed drugs. 

 

When the health care fund is under pressure, competition from manufacturers will be good for price. It is worth pondering the recent FDA new director's approach to competition management. The FDA is considering using the agency's power to the generics market price competition, more directed at high-priced drugs, give priority to approve additional more competitive drugs. The policy is "every generic drugs have three manufacturers", the FDA preparing "if competing manufacturers on the market less than three, the generic application will be priority review" policy. The policy has little or no competition for drugs, because drug monopolies lead to high prices for medicines.