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Generics consistency evaluation of medicinal materials industry
 
Author:中國銘鉉 企劃部  Release Time:2016-12-9 9:31:01  Number Browse:1067
 

Medical network - on December 8, high-profile chemical medicine generics consistency evaluation of nerve thousands of pharmaceutical production enterprises, formulation, active pharmaceutical ingredients and impurities of accessories, craft, reference preparations such as become a hot topic in the industry, but few people to discuss generic consistency evaluation at the core of the intention, and to guide, make the enterprise development strategy planning. National strategic goal is to achieve from the manufacturer to manufacture power conversion, through the implementation of the "three to fill a drop" supply side structure reform, although there is no clear medicine industry as the focus of the reform, but it will also be involved in the pharmaceutical industry. Generic drugs is just one of many medical policy consistency evaluation projects, it is understood that the state will during the period of "much starker choices-and graver consequences-in" established in the whole life cycle management system, eliminate long-term production, small clinical value, curative effect is not exact, the safety risk, efficacy benefits outweigh the risks, and no longer have a better alternative varieties of drugs. Is expected during the period of "much starker choices-and graver consequences-in", the state will further formulate relevant policies to promote the pharmaceutical enterprises from production and sales to convert science and technology service. The change of the pharmaceutical industry is bound to reversed transmission and its closely related pharmaceutical excipients industry adjust.

Drug research institutions or into pharmaceutical excipients main chooser

About 300 medicinal materials production enterprises in our country, the production of medicinal materials of more than 200 kinds. In recent years, anhui, hunan, kang, henan new a batch of companies such as open source, anhui huangshan mountain became a listed company, red sun pharmaceutical co., liaoning oak, lai mei pharmaceutical, fosun medicine listed companies involved in pharmaceutical excipients. After more than ten years of development, medicinal materials industry already have a certain size and strength. Chongqing capability because of its povidone series products adopt advanced production technology, standardized production management, stable product quality, draw materials industry well-known enterprises in Germany freedom meyer and a cooperative joint venture.

Twain 80 is one of the largest accessories in the injection dosage. A few years ago, heartleaf houttuynia herb injection for clinical adverse reactions reported increased, the CFDA full stop the variety of production, after review can only restore the intramuscular injection of small capacity heartleaf houttuynia herb injection, heartleaf houttuynia herb injection from the market. After confirmed, cause allergic heartleaf houttuynia herb injection is the main material of polysorbate 80, rather than h. cordata. And the market and no vial polysorbate 80 production, production injection is used by o-level polysorbate 80, which can only be used for oral and external use. Relevant departments have been put forward for injection accessories, may need to be done in the use of refined. Facts have proven that cannot be refined for macromolecular hybrid material was followed, the phenomenon of the decoloring treatment for common polysorbate 80, but this does not improve security, only to improve the appearance. Nanjing, after several years research prove that twain 80 related to raw materials, processing techniques, the material must use refining oleic acid, the company with a number of research institutions in collaboration with the injection with polysorbate 80 transformation of research and production, make sure the safety of injection using twain's 80. The case prompted pharmaceutical excipients is so intertwined with drug, the relationship between connected, and a complementary makings can determine the life of a drug, determine the rise and fall of an enterprise.

Domestic pharmaceutical excipients enterprises with foreign pharmaceutical excipients gap mainly lies in the fact that the quality of the products (mainly refers to the functional index) steady improvement, the application of pharmaceutical excipients less technical service, shortage of vial accessories varieties, more than in price competition, focus on the low-end customers. Customer request is not high, whether to have more of the approval document for the pharmaceutical excipients for preference, the premise of the pharmaceutical excipients and the compatibility of drug preparation, preparation absence of inner quality concepts such as security, rare for the pharmaceutical companies such as the lack of drug safety responsibility and medicinal supplementary material suppliers.

By pharmaceutical excipients, problems such as keywords retrieval, get 1177 a related research articles, these articles about rare medicinal materials quality and application research, pharmaceutical excipients quality concept, mostly deals with how to strengthen the supervision of administrative examination and approval and as a main measure to ensure the quality of medicinal materials. "Pharmaceutical administration law" regulation, auxiliary materials required for the production of drugs, must meet the medicinal requirements. Obviously, for the same kind of pharmaceutical excipients, due to the difference of application specific drug varieties, dosage form and may be different, this may involve different security and functional indexes of pharmaceutical excipients, etc. Generics consistency evaluation of medicinal materials selection rights and responsibilities will be decided by the pharmaceutical producing enterprises. In a relatively short period of time, the vast majority of the generic drug production enterprise does not have the corresponding ability rapidly, and the corresponding research work entrusted to the drug research institute, drug research institution may be generic pharmaceutical excipients for consistency varieties involved mainly chooser.

Pharmaceutical excipients production enterprise customers

Presumably only a fraction of generics companies through consistency evaluation, pharmaceutical excipients production enterprise of most existing customers original demand will die. Generics consistency evaluation time is tight, demand is high, large, to many varieties of generics companies will choose to study the main varieties, to the weaker generics firms, facing elimination. The consistency of the evaluation by the CFDA 289 varieties, involves the approval number 17740, according to the top three review and market (bidding) preference three priority and price priority, in extreme cases, actual market significance generics approval document for 867, meaning that 95% of existing requires consistency of generic drugs and drug approval document will die, or even passed behind will lose the market. Hint at the same time, the medicinal materials production enterprises pharmaceutical excipients corresponding varieties of customers will focus on a few pharmaceutical companies, if the pharmaceutical excipients production enterprise of pharmaceutical excipients varieties were not through consistency evaluation of varieties in research stage, then less likely to be selected. As customers disappeared, medicinal materials production enterprises corresponding varieties will demand contraction can only choose to shut down, even can also cause some medicinal materials market enterprises from the medical market.

Generics consistency evaluation for medicinal materials industry, the greatest significance lies in the pharmaceutical excipients enterprises promote the pharmaceutical excipients from a single product sales model, into the pattern of technology first, quality first, service first. Recently, Mr G medicine auxiliary, auxiliary was medicine, wantai medicine, outlook for pharmaceutical, capability, new phil, o HuaYao auxiliary, QuFuTian, new open source, wind acquisitive medicine auxiliary, yipin pigments, good quality and Chinese medicine group, Shanghai secco scone and other pharmaceutical excipients production operators and pharmaceutical excipients gathered information platform, and on behalf of liaoyang, liaoning province common Chinese medicinal materials industry development, and decided to set up the Chinese medicinal materials union, set power construction industry pharmaceutical excipients standard platform, application platform, functional index, development of domestic pharmaceutical excipients and the import of medicinal materials quality, such as function indexes evaluation, realize the goal of pharmaceutical excipients production country, power construction.

 
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