Chicken ribs or delicious traditional Chinese medicine preparation in the plight of wandering about in the hospital – preparation – the pharmaceutical industries
Preparation of the application and management of hospital has been in Medicine Community concern. Following the August Beijing Drugs Administration issued "on the traditional Chinese medicine preparation to support medical institutions to inform the relevant issues", the Beijing Traditional Authority has revealed that this part of the excluded Medicare Chinese hospital claims outside the scope of preparation is expected to include health insurance. Gansu Provincial Health Department and the Food and Drug Administration have jointly issued a document recently announced the first batch of Gansu Province transfers recommended by Chinese medicine preparation hospital directory, hospital preparation obtained 93 "province passes" hospitals in the province to transfer .
The introduction of these local policies for the development of traditional Chinese medicine hospital preparations to create certain conditions, but the current compound preparation of Chinese medicine in China is still faced with the standard upgrade price is low, the multiple pressures to protect weak. Many hospitals in the study interrogate when family members are: in the end is to throw away this piece of tasteless Chinese hospital preparation, or to promote the development of the hospital it as it taste?
Access threshold close to the new drug
Order to strengthen the management of hospital preparation, the State Food and Drug Administration has successively promulgated the "preparation of medical quality control agents", "medical preparations Registration" and other documents, not only for the production of standard preparation room, area, facilities, etc. according to GMP standard for management of pre-clinical research hospital preparation, use and registration of declaration and so made the rules.
First CPPCC National Committee, State Administration of Traditional Taiwan, Hong Kong Exchange Cooperation Director Wang Chengde that the current Chinese medicine hospital preparations were requested to manage, the standard is almost close to the standard registration of new drugs. At the same time, preparation room of the new or modified to follow the GMP standard, and ultimately achieving "medical preparations prepared quality control" (GPP). Not difficult to imagine surge in the cost, the dual pressures of declining prices, many hospital hospital preparation to face the difficult choice of whether to go or stay.
General, large hospitals, a larger amount of compound preparation, may also put a lot of traditional Chinese medicine preparation room building of human resources, development agents, to apply batch. But for the average general hospital, the traditional Chinese medicine preparation, not a big amount, the hospital if the single economic benefits from the perspective of development is no longer willing to compound formulations. It is understood that only six hospitals in Beijing preparation room to meet the above criteria, 50% to 70% of the hospital preparation was replaced by commercially available drugs.
Chinese Medicine Hospital of Capital Medical University Beijing party secretary Chen? Said the hospital preparation is the cradle of China's drug research, the standard is too low, do not serve to protect the quality of the standard is desirable. However, hospital preparation is an extension of traditional Chinese medicine prescription, most lines are dozens of flavor compound or drug compound composed of 80% or more of the components can not be clear, it is difficult to modern medical theories to explain the pharmacology, efficacy, ingredients and so on. "If the declaration and approval, it will be in the same western hospital agents to treat, and calls for its pharmacology, toxicology, can be said that not only the pressure in the huge financial input, at the technical level is also difficult to achieve."
Chen? Description, in accordance with the requirements of the hospital preparation room need to put the construction cost, required to reach 100 000 in the clean conditions, in different forms require different facilities and preparation room. This class of cleanliness standard for such high water content mixture, the prone strain formulation is appropriate. But the conditions do not have the external plate of the tincture, creams and so is "anti-aircraft guns to fight mosquitoes." "Certainly the production commissioned by pharmaceutical compound preparations, but because pharmaceutical production lines have already upgraded many times, such as cheap tablet formulations in the hospital is very common dosage forms, has been able to produce the pharmaceutical companies can not find a. "Chen? said.
Wang Chengde that pre-clinical research hospital preparation work required to do long-term toxicity, long-term toxicity test usually takes 6 to 12 million, some non-toxic ingredients for the traditional formulations of traditional Chinese medicine preparation, the need for worth studying. In addition, the higher registration fee, a longer time (6 to 36 months), re-registration more difficult and so many hospitals prohibitive.
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