Analytic Hierarchy Process for Technological Risks in the Process of Innovative Drug Development in China

Objective To identify the critical risks in the process of innovative drug research and development,and to provide reference for improving the efficiency of innovative drug development and risk control in China.Methods Expert investigation and analytic hierarchy process were used to determine the weights of different risks.Results and Conclusion The research and analysis results showed that the risks at different stages of development had different effects on the success rate of drug development,among which the risk at the drug discovery stage influenced the most.In the drug discovery stage,inappropriate target selection had the greatest impact on the success rate of drug development.The lack of appropriate cell tissue or animal models had the greatest impact on the success rate of drug development from the discovery of a compound to the application for clinical trials.The difference in changes between nonclinical and clinical studies had the greatest impact on the success rate of drug development from early clinical studies to pivotal clinical studies.Incorrect dose selection had the greatest impact on the success rate of drug development from pivotal clinical studies to marketing authorization applications.The biggest impact from the marketing authorization application to the approval stage was inadequate communication with regulators.After investigating the weight of risk factors in the process of innovative drug development based on scientific methods,a new perspective for the risk control of new drug development and improving the research and development efficiency is provided.

Identifying and Managing Technical Risks in the Process of Innovative Drugs Development in China

Objective To identify technical risks in the process of innovative drug development,and to provide reference for technical risk management so as to reduce the uncertainties and improve the efficiency of research and development.Methods The initial risk index was investigated by literature research.Then,the Likert scale was used to design a questionnaire,and the experts’opinion was used to analyze the risk factors affecting the different stages of the development of innovative drugs in China.Results and Conclusion Based on the analysis of questionnaire,31 risk indicators of five key stages in the development of innovative drugs from drug discovery to marketing authorization were established.The key risk indicators constructed in this study can provide reference for technology-related risk management in the process of innovative drug development.

Research on the Construction of Evaluation Model for the Development of Biopharmaceutical Park in China

Objective To study the influencing factors on the development of biopharmaceutical park,and to construct an evaluation model of the influencing factors for biopharmaceutical park in China.Methods By analyzing various factors affecting biopharmaceutical parks,an evaluation index system of biopharmaceutical parks and an evaluation model of influencing factors of biopharmaceutical park development based on fuzzy group decision making were established.Results and Conclusion Factors such as research and development(R&D)funding investment,incentive for transformation of scientific and technological achievements,and industrial clusters have a greater impact on the development of biopharmaceutical industrial parks in China.Local governments should increase the investment in R&D funding.Besides,they should pay attention to the incentive of transformation of scientific and technological achievements to improve the innovation ability of enterprises.Meanwhile,they should promote the clustering of high-tech enterprises to comprehensively enhance the healthy development of biopharmaceutical parks in China.

Introduction of PIC/S Accession Procedure and Suggestions for Establishing a Unified Quality Management System in China

Objective To introduce the accession procedure and evaluation of PIC/S,and help relevant departments in China to understand the requirements of PIC/S in detail,and to promote the process of China’s entry into PIC/S.Methods The procedures and steps of joining PIC/S,the evaluation process of PIC/S,and the experience of several countries in joining PIC/S were introduced and analyzed,which could help the relevant personnel in China understand the specific contents.Results and Conclusion According to the requirements of PIC/S,it is necessary to establish a unified GMP quality management system.

Suggestions for Promoting China’s Drug Regulatory Agency to Join Pharmaceutical Inspection Co-operation Scheme-PIC/S

Objective To identify and reduce the gap between China’s drug GMP inspection and pharmaceutical inspection co-operation scheme(PIC/S)audit checklist,find out the key improvement items,and revise them pertinently,which will promote the process of China joining PIC/S.Methods The general situation of PIC/S organization and audit checklist were introduced first,and then the accession of several countries that joined the organization was analyzed.Meanwhile,the process of China’s participation in PIC/S was sorted out.After referring to the contents of PIC/S audit checklist,the problems of GMP inspection system in China were studied.Results and Conclusion There are still many problems in GMP inspection in China.Some suggestions are put forward for improvement and change,which can provide reference for the development of drug inspection agencies at all levels in China.