Risk Identification Research In The Development Of New Chinese Medicines

purpose:R&D of new drugs is a complex project activity that involves drug discovery and screening,preclinical research,clinical trials,new drug applications,production,and sales.Problems in any aspect of the R&D project will directly affect the smooth development of new drug R&D projects,affect the safety and effectiveness of the final drug,and increase the safety risk of drug use.The research and development of new Chinese patent medicines is also a project that many pharmaceutical manufacturing companies are currently developing.How to develop new medicines that are safe and effective and can solve people' s actual needs for health is also a matter of concern to the relevant government departments,society,and companies.This is also a direct concern.It has a bearing on the competitiveness of companies at home and abroad and affects the process of internationalization of Chinese medicine in China.Controlling the risks in the development of new drugs is the key point for avoiding the recurrence of drug injury incidents.The first step in controlling risks is how to effectively identify risks and identify risks.Based on historical events,policies and regulations,and new drug R&D processes,this paper has established a risk indicator identification framework for R&D of new proprietary Chinese medicines through literature research.It combines the severity of risks and the possibility of risk occurrence by experts in the field of R&D and risk management of proprietary Chinese medicines.The evaluation established a scientific identification framework for R&D risk indicators for new proprietary Chinese medicines.At the same time,a simple analysis of risk indicators was conducted to provide a reference for pharmaceutical companies in risk management of new drug development and promote the success of project development.The research results have certain practical significance and practical value for improving the research and development capabilities of pharmaceutical manufacturing companies and their ability to manage risks.method:This research used the literature research method to classify and screen the risk factors in the research and development of new Chinese patent medicines,and preliminarily established a risk indicator identification framework.Through the Delphi expert consultation method,the risk indicator identification framework in the development of new Chinese patent medicines was carried out.Further argumentation,opinions were collected on the degree of severity of each risk indicator C,and the likelihood of occurrence P.Weighted calculations were made according to the ratio of the authority of each expert to the total authority coefficient,and finally the key to the research and development of new Chinese patent drugs was obtained.Risk control points;Through the risk matrix method,a simple evaluation of the identified risk indicator framework was conducted;Through the interview method,the countermeasures for risk management in the development of new Chinese patent medicines were carried out.content:This study first elaborated how to determine the risk classification in the R&D process of new Chinese patent medicines and the process of establishing the index system.Then through communication with relevant experts,it initially identified the risk factors in the R&D process of new Chinese patent medicines and determined them through Delphi ' s expert consultation method.The final risk identification indicator system for the development of new Chinese patent medicines.Through the risk matrix method,the key risk factors in the established risk index system are analyzed and evaluated.Through the output of the risk map,the pharmaceutical companies can intuitively understand the key risk control points in the development process of new Chinese patent medicines.The article finally stood at the perspective of the government,society,and enterprises,and put forward targeted countermeasures and suggestions on seven categories of risks.Pharmaceutical companies provide assistance in the smooth development of new Chinese medicines drug research and development projects.result:This study divides the risks in the R&D of new Chinese patent medicines into technical,market,financial,policy,production,management,and legal risks.There are 78 second-level indicators,passing the first round of experts.For each indicator,the severity of the C value and the probability of occurrenceP were scored.The response of the response expert to the consistency of the evaluation result was calculated using the Kendall coordination coefficient,the importance H value of each index was calculated,and 7 H value variations were excluded.Factor with a coefficient>0.3.Through the second round of Delphi expert opinion collection,the coefficient of variation of the H-values of all indicators is ? 0.3,and the risk identification indicator framework is determined.Weighted calculation of the C and P values of each risk indicator according to the ratio of the authority of each expert to the total authority coefficient,and the risk rating value of each risk indicator is obtained through the publicity of the risk level R=C*P,and the output is 20 Key risk control points.Through the risk map under semi-quantitative and quantitative risk matrix,all risk indicators will be presented for reference by pharmaceutical manufacturers for risk analysis.in conclusion:This research explores the research and development of traditional Chinese medicines in new drugs as research objects,and combines the opinions of experts in related fields to establish a framework for identifying risk indicators.Risk risk rankings are performed for each risk indicator,and corresponding risk management strategies are implemented at the same time.the study.The research method of this article is scientific and feasible,and the research results have a good guiding reference significance for the risk management and control of pharmaceutical manufacturing companies in the process of new drug development.