The second half of the normalization of national mining closely follow the drug life cycle quality management.

Pharmaceutical network September 22nd, after three batches of four rounds of groping, the national volume procurement (referred to as "national mining") into a new stage.
In Beijing, Shanghai, Jiangsu, Yunnan and other provinces and cities began to hang up the third batch of national selection of varieties, the State Health Insurance Administration on September 10 held a symposium on drugs and high-value medical supplies.
conference fully affirmed the effectiveness of the country's efforts, stressed the need to unswervingly advance, while noting that the next focus will be on strengthening the selection of products throughout the life cycle quality supervision, quality issues "zero tolerance."
From the "4 plus 7" when the six-haired two Entikawe to the latest batch of selected metformin, Katopuri and other varieties will be the national harvest into the "one penny" era, with the follow-up of other provinces and should be selected institutional arrangements, to ensure the quality of the selected varieties, to prevent supply risks become the focus of concern from all walks of life.
this end, the State Drug Administration requires that by the end of the year to achieve the whole process of national harvesting traceability.
September 16, the National Health Insurance Administration issued a letter, before the end of the year will establish prices and tender procurement credit evaluation and incentives and disciplinary measures.
this series of initiatives to send an important message: to ensure the quality of national varieties will be the top priority in the second half.
large varieties market compression pattern remodeling August 24, Shanghai Joint Harvesting Office issued the third batch of national selection results, in addition to Ramif fixed flow mark, the remaining 55 generic varieties successfully winning the bid, the winning product rules 191.
compared with the previous four national selection results, the average price reduction of the new batch of national mining results is more than 70%, far higher than the "4 plus 7" average decline of 52%, after the expansion of 59% and 53%, and hydrochloric acid gold down as much as 98.72 percent, a decline of more than 90% of the products as many as 30.
" national mining is the general trend, pharmaceutical companies should seize the industrial chain restructuring, product chain upstream and downstream joint search for new opportunities.
yu Mingde, honorary president of the China Pharmaceutical Enterprise Management Association, said recently that the association conducted a questionnaire survey of 139 pharmaceutical companies at different levels, and 79.86 percent of enterprises adjusted their production and operation.
pharmaceutical enterprises to accelerate industrial restructuring, an important factor is the continuous promotion of national mining.
he also reminded that the current national single enterprise won the bid multi-province, and set the market proportion, will there be supply risk? It will take time to verify.
if the bid price is significantly lower, or even lower than the cost price, will there be quality and safety issues? Next, to ensure the quality of supply of good national varieties must be comprehensively evaluated.
there is no doubt that the normalization of volume procurement is amplifying the crowding-out effect of the market.
According to Dr. Zhang Natural, Specially Invited Vice President of the China Chemical and Pharmaceutical Industry Association, "the market size involved in the '4 plus 7' pilot was 7.7 billion yuan, the actual winning procurement scale was 1.9 billion yuan, and the initial calculation of compressed market space was about 5.8 billion yuan."
, the second batch of state mining involved the market size of 8.8 billion yuan, the actual procurement results of 2.2 billion yuan, compression of more than 6 billion yuan.
third batch involving the market size of up to 22.6 billion yuan, the actual procurement amount of only more than 3 billion yuan, compression of nearly 20 billion yuan.
" he judged, more and more varieties, the market size compression will be more and more.
and this compression, first of all, will be reflected in the clinical use of large varieties.
to say the intensity of the competition, it is not metformin.
this reported 4.66 billion pieces of varieties, accounting for 23.3% of the overall report, and the number of over-evaluated products, the most intense competition.
more than one quotation to be divided into units, with as many as 15 selected enterprises.
it is worth noting that in 2019 the market share of metformin TOP10 manufacturers have not won the bid this round of national mining, with the increasing number of products evaluated, soon the competitive landscape of metformin will be greatly moved.
fact, the exclusive winning bid of 2.08 yuan per piece will also be anti-ED market churning.
2019, the size of the non-national retail market in Xidina was 2.37 billion yuan, while the hospital market was only 120 million yuan.
Guangdong took the lead in implementing simultaneous reporting between hospitals and pharmacies.
from the amount reported, Guangdong pharmacies reported the largest amount of Xidana non-tablets, its pharmacies reported 1522 times the hospital.
some market people said, "after the harvest landing, the market in Xidana non will change dramatically, the current several major products will face the test of life and death."
"If you look at the single product, apixaban, o nitrogen flat, finasteride, Catopri, Mei Jingang, Monrust, Tofatibu and other clinically large varieties will be market reconstruction.
market sources said, "Even if the winning bid is also a number of sub-cakes, the impact of the current national harvest is gradually desensiting, the industry reshuffle will enter the deep water area."
" policy linkage to prevent supply risks Although the third batch of national tenders more than 190 product specifications, more than 130 from the industrial chain more complete pharmaceutical top 100 enterprises, however, all over the province, inter-provincial drug price linkage strengthened, after the normalization of national mining, will there be low-cost competition brought about by the quality risk of drugs? There are still concerns in the industry, which is why the state stresses the need for quality regulation.
, a senior health-care expert who did not want to be named, said: "Strengthening strategic purchases is designed to guide companies to reasonable pricing through a combination of monitoring and early warning, cost investigation, credit evaluation, and suspension of the Internet."
health insurance departments themselves can not investigate, characterties and investigate acts such as unreasonable quotations.
, it is necessary to actively promote the overall cooperation of the departments and explore the establishment of policy linkage mechanisms with the courts, taxation, market supervision and other departments.
" in recent years, some of the clinical best-selling large varieties of shortage, cut-off news from time to time exposed, received widespread attention.
, such as the compound Dansan film also let all walks of life have a lot of heart.
even the selected national varieties, attention to drug safety can not be slack.
To the benefit of hundreds of millions of patients with hypertension, for example, the current five enterprises won the bid, but fully assess the risk of nitrosamine impurities, and control it in the safety limits below these enterprises still need to face the scientific examination questions.
the role of satanyl antitension drugs lies in angiotensin II. subject, blocking the renin-angiotensin-aldosterone system more fully, clinically widely used.
the effects of nitrosamine impurities have been affected by sartan impurities since the events of 2018.
from the point of view of chemical reactions, the appearance of impurities in chemical synthesis is inevitable, enterprises need to chemical synthesis through process research, transformation to the maximum extent possible to avoid.
However, clinical experts believe that "market access standards focus on the reasonable formation of prices, while clinical evaluation according to pharmacoeconomics focuses on drug safety and clinical treatment benefits, how to balance the two is very important."
price factors, the original research products of Lushatan more quality advantages, which brings an era test question: We are pursuing the price or the embodiment of value? She said that the future of national harvesting is also good, the negotiation of drugs, in the clinical benefit risk assessment can not be ignored uncertainty should be taken into account.
May 8, CDE issued a paper on the chemical drug Central Asia nitrosamine impurities research to provide guidance.
drug market license holders/drug production enterprises to effectively fulfill the main responsibility of drug quality management, drug safety and quality of the full life cycle management.
According to Milnet data, in the antihypowder market, the annual sales of the city's public hospitals, urban communities, township hospitals in 2019 totaled 4.96 billion yuan, of which Novarma's salatin accounted for 5 3.14% market share, Changzhou four drugs accounted for 15.09 percent, Hainan Wanglong Pharmaceutical accounted for 7.34 percent, Guilin Huaxin Pharmaceuticals accounted for 7.2 percent, China Resources Seko Pharmaceuticals accounted for 6.96 percent.
the safety of drug use is the primary consensus of the whole society.
strengthen the policy of forming quality supervision at the national level, both hands on price and quality are grasping, both hands are hard.
even the likes of Ao Nipone and Giffeitinib are FDA-certified varieties.
said, "The current health care reform introduced exit mechanism is intended to strengthen the whole process management."
malicious competition at below-cost prices, non-fulfilment of supply commitments, quality problems with medicines, etc. will be included in the list of failures, these initiatives will enhance the sense of access to clinical use.
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