China's multiple measures improve the traditional Chinese medicine injectable preparation technical standard Guarantee security

China's multiple measures improve the traditional Chinese medicine injectable preparation technical standard Guarantee security
Electricity national food medicines on February 25 of www.chinanews.com supervise medicines registered department's chief Zhang Wei of administration bureau expressing while giving an interview today, to the question that traditional Chinese medicine injectable preparation existed, Bureau of Drugs Supervision has already issued a series of policies and measures, guarantee safe the first. Zhang Wei says, traditional Chinese medicine injectable preparation is a component of the culture of traditional Chinese medicine of our country, also an evidence of modern traditional Chinese medicine innovated, have really become China's clinical disease treatment unique means, playing an irreplaceable role. Certainly, traditional Chinese medicine injectable preparation is regarded as the innovative products of traditional Chinese medicine, because its one's own characteristics and developing stages, some varieties really have a weak link. Zhang Wei says, in view of variety, particularity of production technology and complexity of the influence factor of the quality of traditional Chinese medicine injectable preparation compositions, Bureau of Drugs Supervision has mainly taken the following measures: First, improve the registered technical requirement of traditional Chinese medicine injectable preparation, direct against new and listing traditional Chinese medicine injectable preparation especially. Make " traditional Chinese medicine registration management additional regulation ", should define the crude drugs source and requirement for the technical data to develop after putting forward traditional Chinese medicine, and bring into the control links of guaranteeing traditional Chinese medicine quality, combine the finished quality index to measure, realize progressively " The source is controlled " , " the course is controlled " With " control of index " The quality certification system that the three combine together, to guarantee one and stability of traditional Chinese medicine quality. In addition, direct against traditional Chinese medicine injectable preparation variety, has also specially released " traditional Chinese medicine, basic technical requirement of natural medicine injectable preparation ", technical standard that has mainly further improved traditional Chinese medicine injectable preparation from respect of setting up the question basis, preparing the craft, quality control, stability, security, validity etc., stress that has emphasized the security of traditional Chinese medicine injectable preparation. Second, increase safe properties and accuse of measuring, accelerate improving the traditional Chinese medicine injectable preparation standard at the same time. Recent years, Bureau of Drugs Supervision improve to work the intersection of medicine and the intersection of injectable preparation and standard of variety, classify as the key content that the national standard improves the action plan, is supported by the project fund of state revenue, the provincial medicine inspecting institute arranging for comprehensive strength to be strong undertakes to study and improve the work, finish the daily traditional Chinese medicine injectable preparation standard to improve by stages and in groups in a planned way, through increasing the detection project of security, improve the level of control on product quality. Third, launch security and appraise the work again in an all-round way. The traditional Chinese medicine injectable preparation security that will be launched in 2009 comments on the work again, carry on the work from three respects: The risk arranges and checks the standard, appraises synthetically, improves. As to because can't according to the intersection of national standard and variety, variety, variety that security have a big risk that produce for a long time of production already in issue in resource,etc. in source, crude drugs in base in crude drugs, pass after the appraisal, unqualified to eliminate from. Fourth, strengthen the injectable preparation production ink of traditional Chinese medicine to supervise and inspect. Produce traditional Chinese medicine injectable preparation as the supervision focal point, accredit supervisors to all traditional Chinese medicine injectable preparation manufacturing enterprises, strengthen the dynamic supervision of production. Have launched injectable preparation medicines production technology and prescription in the whole country and verified the work, and regard traditional Chinese medicine injectable preparation as and verify the focal point, is devoted to looking for the quality safety risk of production through verifying, get rid of the potential safety hazard, guarantee product quality. Zhang Wei points out though whether the completion of the medicines quality criteria influences the quality of medicines to guarantee competence to a certain extent or not, but the medicines quality criteria is not to solve the master key of the inherent quality of medicines, it just guarantees a respect of the quality of medicines. Also need the manufacturing enterprise and strengthen supervision from links such as the production of medicines, circulation, using,etc., it is left together, could solve the quality of medicines and problem of the security that multicell to medicines supervision department. In addition, it is an endless job that the standard is improved, it should be carrying on with scientific and technological progress and industry's development level constantly completely. (put in order according to www.xinhuanet.com's written broadcasting live)

|