15 first batch varieties of generic drugs advanced by consistency evaluation started one after another

Source: on June 5, 2013, pharmaceutical economic news, the work of quality consistency evaluation of advanced generic drugs by means of consistency evaluation (hereinafter referred to as consistency evaluation) is stepping forward At present, 15 first batch varieties including cefuroxime ester tablets and simvastatin tablets have been launched successively The reporter learned from Harbin Pharmaceutical Group, Huabei pharmaceutical, Shenzhen Zhijun, Di'ao patent and other enterprises that some key varieties with high market share have been selected and determined, accelerating the consistency evaluation work, hoping to improve the market value and lasting competitive advantage of its core products through quality benchmarking and bioequivalence test Jian Xiaona, head of the R & D center of a pharmaceutical enterprise, said: "all the leading enterprises hope that the important products can be evaluated as soon as possible After all, the work promoted by the state is the recognition of enterprise technology, which is conducive to the establishment of technical competition mechanism in the pharmaceutical market." However, she also said that at present, because the catalogue of reference preparations has not been published, nor has the evaluation plan and evaluation method been published, enterprises can only do some basic research on their products first For example, to study the influencing factors of dissolution curve determination of various varieties, and to explore the differences of preparation prescription, raw and auxiliary materials, process dissolution curve, etc In addition to the first batch of pilot varieties such as ciprofloxacin hydrochloride tablets and simvastatin tablets, the second batch of 50 varieties are being determined, and the horn to improve the internal quality of the generic drugs has been sounded At present, there are 16000 kinds of drugs approved for marketing in China, with 187000 approvals Among them, there are 7000 chemicals and 121000 approvals, most of which are generic drugs It is necessary to face up to the fact that although the quantity is large, there are differences in the clinical efficacy of domestic preparations, especially oral solid preparations due to the incomplete quality evaluation methods, which are inconsistent with the original research drugs or reference preparations, and even affect the safety and effectiveness of clinical medication, so it is urgent to develop the quality consistency evaluation of generic drugs According to relevant regulations, generic drugs approved before October 1, 2007 will not be registered if they fail to pass the conformity evaluation The consistency evaluation of generic drugs requires that the components, dosage forms, standards, effectiveness and safety of generic drugs and original drugs or reference preparations should be consistent At present, many enterprises are counting their own products and making choices, and selecting qualified products to prepare for re evaluation as soon as possible The reporter learned that SHP has sorted out and summarized all the drugs of the group, and preliminarily determined the list of products to be evaluated and the work plan Harbin Pharmaceutical Group has set up a technical quality improvement team to accelerate the quality consistency evaluation of the first batch of generic drugs launched by the state and ensure the company's products pass Some experts pointed out that domestic generic drugs are difficult to participate in international competition and lack of differentiation in domestic market competition The key lies in the defects of generic drug research, low technology content in production and enterprises falling into the strange circle of low price competition The purpose of consistency evaluation is to promote the pharmaceutical enterprises to pay attention to the understanding of the characteristics of the drugs they produce, and constantly improve the technical level, so as to improve the level of preparations and high-end manufacturing capacity in China To grasp the two key points for dissolution detection technology, China only required to meet the requirements of the existing quality standards for dissolution, which resulted in the "seeming separation" between generic drugs and original research drugs Kang Pengcheng, chairman of Beijing kanglihua Consulting Co., Ltd., said that from emphasizing the single terminal control of "quality standard" to strengthening the "preparation process control" and implementing the whole process control of drug quality, it will have a great impact on the industry "It is suggested that enterprises should know more about the quality standards of the same or similar varieties at home and abroad, track the development of quality control, and use it to guide research and development and evaluation From the usual research, due to the lack of objective evaluation methods and indicators, the competition of products is often simply in the price competition, while the drug pricing mechanism, bidding policy, medical insurance and comprehensive reform of public hospitals have urged enterprises to pay attention to market channel development, but ignored the in-depth study of preparation technology " Kang explained With the successive expiration of blockbuster patent drugs, more new generic drugs are bound to enter the research and registration applications The competent department has made it clear that multiple dissolution curves should be consistent in the quality consistency evaluation of oral solid preparations In this regard, jianxiaona mentioned that the industrial technology capacity related to solid preparations will affect the consistency evaluation, and the excipients have a great impact on the quality of preparations There are differences in some functional indicators of excipients purchased on the market To do a good consistency evaluation means that pharmaceutical enterprises will further refine the requirements for the quality and functionality of excipients In addition, the correlation between dissolution behavior and clinical efficacy needs to be further explored Many small enterprises will withdraw from the market due to lack of research ability It is suggested that the incentive policies of varieties through consistency evaluation should be specified so that enterprises can have enough motivation to carry out in-depth research.