On The Basis Of The Risk Of Post-marketing Drug To Sample Model Research

With the development of science and technology and the internationalization of the drug market, drug quality problems have attracted more and more global attentions. According to the preliminary estimate of WHO, sales volume of counterfeit drugs accounts for10%of the whole drug sales around the world. And in some developing countries, the amount reaches up to50%. The conventional sampling and testing model can no longer meet the marketing surveillance demads of the authorities under the increasingly complex market circumstances. To simply characterize the quliaty level of drugs by percent of pass is unscientific. An increasing number of high-technology adulterate means and potential safety hazard bequeathed at the phase of research and development makes it difficult to assese the drug objectively using criterial surveil approaches. At the high incidence stage of drug risks, it is necessary and worthy for us to probe into what we should do to improve the efficiency of sampling and testing and how to control safety risks of drugs using testing methds.This research aims at exploring how to establish a risk-based drug sampling and testing model corresponding with our national conditions so as to improve the efficiency of surveillance and ensure the safty use of drug for the public.The theory support and starting point of this research is quality risk management and the concept of Quality By Design. To borrow ideas from US and Europe is of great importance in the process of this question. However, the US and Europe drug markets are on different development phases and historical period compared with ours, so it is critical to establish a model corresponding with our national conditions when learning from others’experiences.This research uses literature research, comparative research methods, index analysis and cluster analysis and other statistical analysis methods to compare the concept, procedure, evaluation methodology, supporting functions for drug supervision between our nation, US and Europe.Our core idea is the theory of risk management. We have chosen four assessment sampling and testing breeds (including two traditional Chinese medicine breeds and two chemical medicine breeds) and conducted quality risk evaluation to design our own maketing sampling and testing model.Becaulse there are a large number of manufacturers and intermediate links in our nation and the social credit system has not been fully set up, more factors would affect the drug safety compared with developed contries. The developed contries like US and Europe have already set up a full equipped market competition and marketing surveillance system and the safety influencing factors of drug would be grasped more easily. The research holds the point that the differences of surveillance environment directly influence the sampling and testing idea.This research holds the opinion that there should have some differences between marketing surveillance and assessment sampling and testing in their objectives, project designs, result announcements, supporting functions for drug supervision. The marketing surveillance sampling and testing should choose high risk products, focus on process control, be accompanied with GMP and GSP inspection, and the final results should give supports directly for surveillance and punishment. The assessment sampling and testing’s objective should be on the point of Quality By Design to find the problems on drug standard and drug registry on the basis of the testing results. At the same time, to evaluate the risk situations of different manufactures, revise the standard and registration and give support for surveillance, it even may be helpful for drug pricing.This research shows that according to the regulations of our nation, many methods are worthy of exploring for marketing surveillance sampling and testing and drug evaluation sampling and testing, such as Cluster Analysis of Statistical Analysis. On the basis of drug risk evaluation, sampling and testing can be valuable references for drug surveillance, drug pricing, and reflecting the differences in manufactures.