Research On The Method Of Secondary Development And System Building Of Chinese Patent Medicine

Since The Provisions for Drug Registration Published in 2007,our country raised the reporting standards of new drug and generic drug. The Provisions for Drug Registration encouraged to produce the drug who highly improve the quality, safety, efficacy, but limited to produce the drug who only change the formulations. To some extent, The Provisions for Drug Registration reduced the number of drugs who only change the formulations. It is a great challenge for pharmaceutical industry, but it is also avoid the increased competition. If the enterprises wanted to maintain the advantages they have, they must put all there heart in discovering new drug or stable the market position of their drugs. Objective:through the summary of drug's manufacture, examine and approve, using status, analyses the defects, discussing on the manner of secondary development of proprietary Chinese medicines, to ensure drug safety of patients and reduce the risk of corporate responsibility. Method: analysis usage of the proprietary Chinese medicines, to establish the model of Chinese patent medicine. To make sure the imperfect of second development has been changed. Result:We haven't a law or administer system to standard on Chinese patent medicine. Conclusion:The way we produce and use medicine is already deviate from basic theory of traditional Chinese medicine, the enterprise may facing liability risk.. Through improve the reporting of adverse drug reactions and drug re-evaluation system, to make sure the enterprise can get more details from it.