Studies On The Actuality And Strategy On Innovative Drugs In China

The drug is an important material for the prevention,treatment,and diagnosis of human diseases.The innovative drug is referring to the drug that has not yet listed at home or abroad.Through analysis of the declaration and review of innovative drugs in China from 2007 to 2012,as well as FDA and EMA approved new drugs from 2003 to 2012,the current status and the concerns of innovative drugs R&D in China was characterized.Currently,the innovation at the overall level of China’s pharmaceutical industry is still low;the development is not balanced;the research organization and teams suitable for the innovative drugs development have not been established.Based on the R&D characteristics of innovative drugs in China,the construction of research mode and evaluation mode for innovative drugs was further discussed.In the view of innovative drugs,we should pay more attention to the project,the risk control,and the development strategy.Project should be based on the clinical needs to meet the requirement of human beings.In order to control the risk during the R&D process,we should determine the appropriate purpose,the optimized R&D mode,the reasonable R&D plan,and the control mechanism in the whole process.In the R&D process,we should establish different development strategy according to the R&D characteristics of innovative drug,promoting the R&D process and controlling the risks.For the evaluation of innovative drugs,it is necessary to construct an appropriate evaluation system and set evaluation organization and personnel in accordance with the characteristics of innovative drugs.Meanwhile,in combination with the characteristics of innovative drugs and the evaluation situation in China,much attention should be paid to the examination of the project,the robust of the technical requirements,and the adjustment of the evaluation strategy in pharmacy.To promote the quality of R&D and evaluation for innovative drugs and reduce the risks,a smooth communication between applicants and evaluators is very important.FDA has established a regular conference communication mechanism that plays an important role in improving the quality and reducing the risk in the process of decision-making.We can learn from the experience of the FDA,combined with our innovative drug research status quo,to build our own conference communication mechanism.