From " imitate the standard " Move towards " imitate the variety "

From " imitate the standard " Move towards " imitate the variety "
Though staff reporter Wang LeMin China models medicine big countries, even modelling medicine field, also be still deserved to be called the imitation medicine powerful country. Reason one of, our country model technical requirement of medicine in the past and standard grasp disparity stores in even. At present, national food medicines supervise the administration bureau proposing, modelling medicines should be from " imitate the standard " Move towards " imitate the variety " ,While improving our country and modelling medicine level, have brought the new challenge to domestic medicine enterprise too. The medicines quality control idea is changing in recent years, the idea of quality control of medicines is changing constantly in the world: Until " whether medicines quality to come control through test " " the quality of medicines is realized by that the production process is controlled " to get ,And then get again " The quality of medicines was produced out through the good design " . National food medicines supervise medicines registered department's chief Zhang Wei of administration bureau saying, this means medicines begin to consider the quality of the final products soon from researching and developing. Fill a prescription design, craft route confirm and technological parameter choose and the intersection of supplies and the intersection of person who control and all respects need to further investigate, accumulate the specific and accurate data, and confirm best products prescription and production technology according to this. According to the change on this kind of idea, require move gradually in the control point where the quality of medicines supervises, rely on the examination and test of products of end simply from the past, to the control on production process, and then reach the design of the products and control which study stage. Say briefly, strengthen medicines to register and supervise from source, guarantee the quality of medicines and security. As modelling medicine researching and developing and big producing country, the quality of medicines supervises and manages the change read and displays the loophole that imitation medicine researches and develops. With this, national food medicines supervise the administration bureau to revise and issue new " medicines register management " July 10, 2007, requirement for modelling the research and development of medicine, declaring examining and approving and produced and proposed higher, putting emphasis on modelling medicines should keep unanimity with medicine modelled on security, validity and quality. This change only modelled medicines in the past " Just accord with the national standard " Method. Model medicine management from " Imitate the standard " Move towards " imitate the variety " ,Thus the medicines guaranteeing to be modelled out and medicine modelled have the same curative effect. Zhang Wei says, should recommend country's setting up and innovating strategic plan, pass a series of corresponding policy of the registration management of medicines, through promoting the standard of imitation medicine, to improve the reseach that China model medicine, register competence. Imitate " well " With " look like " Who should it imitative to model medicines? The idea of our country was to imitate the standard in the past, accorded with the national standard just, but not imitated the variety, and foreign modelling pharmacology and reading is to imitate the variety. Zhang Wei says, goes over, the intensity that we require imitation medicine to imitate should reach 60 points or 70 points. Should raise the quality now, it must be imitative to model medicines to " look like " With " good " . What is to imitate the variety? The new " registered management of medicines " stipulates: "Modelling medicines should have the active composition equally with medicine modelled, give medicine route, dosage form, specification and the same therapeutic function. " The new clear concept of defining imitation medicine of " registered management of medicines ": "Model medicines and apply, refer to producing national food medicines and supervising the application for registration that the administration bureau has already sanctioned medicines that have already had the national standard going on the market. " An expert explains, it is identical that the goal in research that has had national standard medicines already should reach the security, validity with the already listing products, namely curative effect and already listing products of developing products are about equal, security is not lower than the already listing products. Pharmacy foundations that different production units realize this goal may be different, may adopt different raw materials medicine to prepare the prescription crafts of craft, preparation, this may cause the difference of control methods of product quality. So, in already having research of national standard medicines, can't apply the existing national standard mechanically mechanically, need following " Imitate the variety instead of imitating the standard principle " ,Namely in have national standard in the reseach of medicines already, in order to develop products until listing security, validity of product identical as the goal already. Medicine enterprise it faces new tests to be to model the intersection of medicine and big country in our country, especially traditional Chinese medicine model in recent years presenting tendencying of blowout, blue root preparation of a kind of board, more than 1000 enterprises are producing in the whole country, this causes too many, too excessive imitation medicines. With its traditional Chinese medicine function complicated in material base, function mechanism indeterminate, traditional Chinese medicine model medicine can't come on, judge curative effect by simple the intersection of quality testing and index, very difficult guarantee of the quality of medicines. On January 8, national food medicines supervise the administration bureau releasing " traditional Chinese medicine registration management additional regulation " clearly, the application for registration which models medicine of traditional Chinese medicine " should be with making up the prescription of modelling medicines, crude drugs basic former, production technology ' Including pre-processing, drawing, separation, purification of crude drugs,etc.) And technological parameter, preparation prescription keep unanimity, the quality controllability can't be lower than medicines modelled. " National the intersection of Bureau of Drugs Supervision and medicines register the intersection of department and the intersection of traditional Chinese medicine and RunSheng Dong, division chief of, say, this time thinning imitation technical requirement of medicine, the reason is our country's none of totally controllable traditional Chinese medicine quality criterias, can't embody every composition of traditional Chinese medicine with the standard. So, have modelled and proposed " imitating the variety to medicines instead of imitating the standard " this time Principle,in modelling only to last medicines imitation and model into medicine to reach unanimity in security, validity in reseach of medicine. He say from " imitate the standard " the intersection of management and idea of medicine to model " the additional regulation " Change into " Imitate the variety " ,Stipulate imitation medicine answer and imitate into variety base original producing process,ing keeping consistency in the intersection of prescription and composition, crude drugs, or prove and is modelled the consistency of variety quality by clinical trial, thus further standardize medicines to model and improve the technological threshold of imitation medicine, the medicines guaranteeing to be modelled out and medicine modelled have the same curative effect. Model medicines to register and apply to be reducing 2008, national food medicines will supervise the administration bureau and accept medicines and register 3413 applications together, drop by 75% and 18% respectively compared with 2006 and the same period of 2007, it is mainly caused by modelling medicines and applying and changing dosage forms,etc. to apply for the substantial decrease of the quantity briefly. Among them, model medicines and apply to drop by 85% and 46% compared with the same period of last year respectively. This reflects that registers and declares the quantity to begin to be proned to normally to a certain extent, the registered applicant prones to reason further, medicines research and develop the order and take a favorable turn progressively. Zhang Wei says, it is to the challenge of grinding medicine and patent medicine to model medicines originally, the purpose is to reduce the cost of medicine, improve patient's acquired character to medicines. The reason why, model medicines in China much, through this kind of standard promoting, there will be modelling medicines and going on the international market of more better China in the future, participate in the international competition, give play to our country to model the advantage of medicine. The intersection of Jiangsu and general manager of traditional Chinese medicine group Yan Wu The policy thinks, for now, it is unrealistic to invest a huge sum of money to develop innovative medicine of patent to most domestic-investment enterprises, it is a main subject to model overdue medicine of patent, it is the main target that the national basic medicine catalogue records too. Has improved the threshold of examination and approval of imitation medicine, to domestic medicine enterprise specializing in modelling, the new round of to test and already come.

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