Medical network - on March 21, since the end of February 2017 edition of national health insurance directory after the release, medicine policy is dense, the policy effect on different types of enterprise is different, it may be said "someone glad someone sorrow".
Multinational drug firms declare process changes
On March 17, state food and drug administration issued the decision of adjust the imported drug registration management related matters (draft) ", said it would make the following adjustment for imported drug registration management related matters:
A, in China with international multicenter drug clinical trials, cancel the clinical trials should be registered outside the People's Republic of China with medicine or has entered the stage II or III clinical trials, vaccine except drugs.
Second, for international multicenter clinical trials in China, after completion of the international multicenter clinical drug trial can be directly put forward listing application for registration of pharmaceuticals, Registration and listing shall be implemented by the drug registration management measures "and other related documents.
Three, for applying for import of chemical drugs and drug treatment with biological products innovation, cancellation shall obtain overseas pharmaceutical manufacturers in producing countries or regions listed licensing requirements.
Prior to the release of four, for the purposes of this decision, has been accepted by international multicenter clinical trial data without doing the import registration of clinical trials, in conformity with the requirements, can approve the import.
The policy of the signal is: national international multicenter clinical trial restrictions to completely let go. Globally, is vital for new drug development the first phase of clinical trial or early phase ii trials, China gate will open. Then, as business mainly engaged in the clinical trials of tiger medicine (300347) will significantly benefit.
The first reference preparation
Or on March 17, state food and drug administration issued the reference about the release of generic drug preparation directory (first batch) circular, 51 varieties released the reference preparation. On August 9, 2015, promulgated by the state council on the reform of drug approval system of examination and approval opinions requires a consistent evaluation of generic drugs. Consistency evaluation work, there are two important factors: one is the reference preparations, determine the content of namely; Second, the clinical trial base. Today, the first reference list released preparations, clinical trial base nervous problem also in the solution. Therefore, related drug firms generics consistency evaluation to speed up.
Through consistency evaluation of generic drugs, its quality is considered the same as the original drug, clinical priority will be to use the "alternative" generic drugs. For countries and people, can reduce health care spending, reduce the medical burden. For production of generic drug company, can improve the efficiency. As a result, the production of the first batch of 51 reference preparation of generic drug firms will retain the advantages of time. We have noticed that some domestic reference preparations on the first list of generic drugs is the exclusive production, or the production of factory is not much, the speeding up of consistency evaluation is more advantageous to the enterprise. Such as acarbose, there is only a east China pharmaceutical generics; Only cefuroxime ester jing new pharmaceutical production of generic drugs and share a few manufacturer.
A new round of basic determine price negotiation
Last week, "E medicine managers" said in a news release, people club department in the first round of price negotiation directory 45 basic varieties have determined that are currently confirm stage. About 35 varieties for imported varieties, one of the few domestic varieties mainly comes from 2008 to present approved domestic 1.1 class of new drugs.
National drug price negotiations for some patent drugs and exclusive rights to produce drugs lack of competition in the market, the price on the high side, by the state to adopt the method of unification talks, reduced the price to a reasonable range. This is a form of quantity for price, to a large market share of the country to negotiate with drug companies, as for patients with more reasonable prices. For drug firms is also a rare historical opportunity, because the drugs include direct access to public hospital procurement directory, and at the same time, linking to the health care that is equal to the futures into two major difficulties of drug market. In 2015, issued by the general office of the state council "about perfecting the public hospital drug centralized procurement guidelines", the formal implementation of the national drug negotiations work.
E medicine managers is found, there are five domestic new drugs could be entering a new round of national drug negotiations, among them, the involved hengrui pharmaceutical and medicine of zhejiang a variety.
Involve hengrui pharmaceutical is a path for, which is the world's first in advanced gastric cancer proved effective small molecular targeted drugs, developed independently by hengrui pharmaceutical, in October 2014 by the state food and drug administration approved and applied to the clinical treatment of advanced gastric cancer, at the same time also is expanding lung cancer, liver cancer, and other indications. Relevant data show that new gastric cancer cases 1 million cases a year, more than 70% in southeast Asia, China ranked first; Relevant statistics show that in 2015, the main city public hospital path for sales of 58.42 million yuan, and can include health definitely had a huge impact on its market volume. For the moment, many mainstream gastric cancer drugs have been incorporated into health care, for the non-standard products advanced gastric cancer first-line drugs for now gonow's annual sales of 3 billion yuan. Therefore, if the can smoothly enter the health care, through further price negotiations path for, will have greater market space.
Is involved in zhejiang pharmaceutical nai effect, which is in October last year to successfully listed in national a class of new drugs. In June 2012, zhejiang medicine from too scene biological technology co., LTD and scene pharmaceutical r&d (Beijing) co., LTD., obtained the product patent rights and rights in China. Data show that the similar products quinolones in 2015 global sales of $2.023 billion.
Imported drugs has become the varieties, in a large extent, also conducive to the generics market open, so, after the order which we will also focus on imported drugs listed in the national list.
March 15 ~ 16, human resources and social security ministry convene a meeting of the commissioner of the national provincial health care health insurance company, focus on adjusting the b class directory, medicines, negotiations and subsequent dynamic adjustment, etc. Urging provinces, according to news from the meeting, the ministry announced on July 31 provincial health b drug adjustment scheme, adjust the amount of 15% (291), the number includes inlet, v and using range adjustment. The personage inside course of study thinks, the actual adjustment space is not large, according to the usual situation, the 291 basic lock in the new drug and limit range adjustment, not into the national directory of drugs, as long as there is clinical value, where the chance of going to supplement the door is open.
Strong countries will push prices "naked"
From the pharmaceutical industry WeChat public, "" blue" parker, on a year's drugs ex-factory price information traceability system, has confirmed that will officially post implementation in June this year. Also that the state will establish a unified across departments and drug information platform, the national price information network with tender, health care, taxation, which penetrates the drug prices.
On February 9, issued by the general office of the state council concerning the further reform and improve the use policy for producing and distributing medicines of several opinions, clear: "improve the drug price monitoring system, and promote the drugs market price transparency. The food and drug regulators led start establish drugs ex-factory price information traceability mechanism, establish a unified price information platform across departments, prepare and drug centralized purchasing platform (public resources trading platform), medical insurance payment platform, interconnection, strengthen and sharing of data related to tax."
File at the same time stressed that "to inflate the price of raw materials and pharmaceutical factory price of drug manufacturers, prices, food and drug supervision, taxation and other departments to investigate in accordance with the law, pay taxes receivable, shall be investigated for the responsibility of the relevant responsible persons. Strengthen the insufficient competition pharmaceutical factory (port) price, the actual purchasing and selling price monitoring, the abnormal price changes or with varieties of drugs price difference is too high, should be timely research and analysis, when it is necessary to carry out the cost price of special investigation."
So, in today's camp, instead of two votes, against the background of docking drug prices back again if monitoring platform system, drug prices to achieve relatively transparent has no any obstacle, the domestic production enterprises of production costs, profits, costs can be financial calculation and audit. After that is to say, drug companies can only be reasonable profits, to disadvantage enterprise will be market ruthless eliminated, and drive the industry consolidation, as a whole is conducive to the development of competitive enterprises. |
