Pharmaceutical innovation: China bid farewell to era of low-level repeat – preparation – the pharmaceutical industries
New Drug R & D policy in the stricter market is big situation, the domestic pharmaceutical innovation has reached a high level, it is imperative identify the development effort towards improving the industrial level.
Domestic R & D pharmaceutical industry as a whole lower level of maturity and state regulators make a real pharmaceutical innovation is even more urgent at the same time, a huge market space and business development needs of its pharmaceutical innovation has become the driving force. Globalization in the pharmaceutical market situation, the Chinese enterprises to achieve pharmaceutical innovation, where the direction of innovation? This will undoubtedly become the business and industry now have to think about the proposition.
Reconsider formulations of rational change In fact, the overall strength of our pharmaceutical companies and the pharmaceutical industry R & D level of restrictions, the new molecular entities, drug development companies in the country only a few dare to set foot in, pharmaceutical innovation has been the domestic enterprises is an important way for new drug innovation. But in 2007, before the drug dosage forms, innovation, more market reform formulation is intended to obtain funding to support national policies and in the provinces and cities bidding to get the edge on the bargaining. Formulation of innovative and practical significance can not be truly reflected.
To control the low-level repetitive situation, the state amended in 2007 to implement the new "Drug Registration" (hereinafter referred to as "measures"), re-emphasized the definition of new drug development to strengthen the reform of the pharmaceutical formulations and drug delivery approach to change management, etc., in order to fundamentally eliminate the pharmaceutical industry "is not a new drug" situation.
According to recent communications from the State Drug Registration Department approval of drug registration situation, the "measures" to implement effective control of the last registration of pharmaceutical dosage forms of the phenomenon of a simple change, change for the proportion of pharmaceutical dosage forms decreased. In 2008, the State Food Drug Registration and Drug Administration received a total of 3,413 applications, with 2006 and 2007 decreased compared to 75% and 18%. This is mainly due Generic Application and simple to change the number of dosage forms such a significant decrease in applications, of which generic drug applications and simple application to change the number of formulations were down 85% and 46%. Love the hair
Shanghai Pharmaceutical Co., Ltd. Deputy General Manager Xu Fukun that the decline in the number of drug approval and the approval of the new "approach" has much to strict requirements, Pharmaceutical companies No longer blindly follow suit, not for the declaration of the declaration, began clinical significance, research and development, cost of a comprehensive assessment of the reasonableness of change formulations.
Direction of pharmaceutical innovation is still the one
It is noteworthy that the new "measures" after the implementation of drug registration in China the number dropped significantly. He explains the low level of China's pharmaceutical R & D duplication phenomenon is suppressed, it also reflects the innovative capacity of China's pharmaceutical companies are still relatively low, the development of formulations for simple way to change there is a strong dependence. Pharmaceutical Industry
this situation is difficult to improve in the short period of time. Thus, while our review of the approval system for drugs has matured, gradually increasing the threshold for approval, but the dosage forms to improve business development model is still one of the effective breakthrough is coming for a long time the Chinese pharmaceutical industry an effective way out of difficulties and low added.
The formulation of experts emphasized that the approval of regulatory authorities to improve drug registration threshold is to encourage genuine innovation, control does not change the clinical superiority of the simple formulations of drugs listed. Therefore, the preparations for the most innovative enterprises, especially large producers in terms of generic drugs, is still an important direction for future development, but must be based on a "clinical superiority."
Xufu Kun told reporters that new drug development, especially the first and second drugs into large, long period, China's pharmaceutical enterprises are currently not strong comprehensive strength, making drug research, technology, personnel, equipment, market Marketing And the continuous chain of funds are not guaranteed; In addition, the current level of domestic accessories, preparation techniques behind the foreign, therefore, pharmaceutical innovation is still the future of China's pharmaceutical industry, one of the main development direction.
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