Traditional Chinese medicine parenteral solution needs to improve " Appraise after being listed " System

Traditional Chinese medicine parenteral solution needs to improve " Appraise after being listed " System
In recent years, the parenteral solution bad reaction incident of traditional Chinese medicine takes place frequently, from stinging five plus, mattress Zhi is yellow, a pair of the rhizome of Chinese goldthread, to fragrant red parenteral solution. As to this, national Bureau of Drugs Supervision says, some existing injectable preparation varieties, it is relatively weak to develop the foundation, the production technology is defective, quality level is not high, there are certain potential safety hazards, will launch the work of appraising to injectable preparation medicines after being listed successively this year. (" Beijing Times " of March 25)
Traditional Chinese medicine parenteral solution, are proud of some experts in the industry, is regarded as the revolution of Chinese medicine - -The doctor of traditional Chinese medicine sweeps the former appearance, united by marriage with modernized science and technology. Who does not know, the present situation is: This is united by marriage and unhappy. The fault is not united by marriage or not, but " get married " hurriedly ,After marriage is also anxious to make money. The protecting amount of manufacturing enterprise of medicines does not guarantee the quality, often there are several even a dozen or more to produce producers with a traditional Chinese medicine parenteral solution, a producer goes wrong, influences the sound development of the whole traditional Chinese medicine parenteral solution industry directly. The same as way to stop traditional Chinese medicine parenteral solution of letting in the past, what Ministry of Public Health called stopping promptly is traditional Chinese medicine parenteral solution of the same lot number of an enterprise, this kind of traditional Chinese medicine parenteral solution of not all enterprises. However, can predict, this will exert an influence on sale of the whole medicines of fragrant red parenteral solution, involve a plurality of enterprises.
2007,>(State Council office sends (2007) The 24th) Item 3 of the second paragraph of article 3 - -"Make " medicines comment on management again ", make related technical specification and guide, appraise and study already listing medicines again by stages and in groups. Set up and improve medicines monitoring, prewarning, long-efficiency mechanism of risk management that meet an urgent need, dismiss from the city, eliminate after listing " --Already clear to appraise the construction of the system to listing medicines again. After two years, it is still beset with difficulties that medicines are appraised after going on the market. I have a look around thesis in these, find in our country, and then it is mostly in very coarse level to appraise the systems, moreover, concentrate on the little clinical sample to observe, quite a lot are one kind of such forms " to * * Parenteral solution * The clinical observation of the example " ,Lack observation of the big sample with technological content and clinical research that the Hi-Tech experiment means gets involved.
This no wonder these researcher, because they mostly clinical medical personnels too, there is not a lot of reasearch funds. The most strong one is medical enterprises, but an interesting one is: After medical enterprise medicines register and get codes, ignore the intersection of security and issue after medicines list warmly on nothing ' Mainly still because chase the heart of the profit too far) . The listing medicines that and the country is unripe comment on the system on small scale, it is unable to carry on the lasting supervision of systematic science to the medicines manufacturing enterprise. Then it is awkward to fall into: The supervision department is unable to do what one wishes, enterprise tries one's best to leave medicine alone.
Appraise as to the intersection of traditional Chinese medicine and medicines of parenteral solution after going on the market, just because author's aforesaid awkward predicament, having just caused present problem traditional Chinese medicine parenteral solution to find one, supervision department goes to stop up one, there is " mend the fold after the sheep have been stolen " Compassion feeling. But the sad feeling is not pessimistic, approve the experience of degree higher U.S.A. FDA is seen from world, it is the only passway guaranteeing to only set up and improve listing medicines and appraise the system again progressively traditional Chinese medicine parenteral solution survives.
Beijing He ZuYong ( Master of medical science)
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