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.

Research on Reimbursement Management of Innovative Drugs Abroad and Its Enlightenment to China

Objective To analyze the reimbursement policies of innovative drugs in some developed countries,and to provide reference for future reimbursement management in China.Methods Literature research method was used to study the policies related to the reimbursement management of innovative drugs in Germany,France and Japan,and their successful experience was summarized.Results and Conclusion China should establish an open and transparent value evaluation standard to improve the medical insurance reimbursement management of innovative drugs.Besides,the value of innovative drugs should be taken as an important basis for reimbursement decisions,and an independent third-party value evaluation agency must be established.

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.

Inspiration of Foreign Innovative Drug Pricing Methods and Medical Insurance Payment Standards to China

Objective To study the innovative drug pricing methods and medical insurance payment standards in foreign countries and to provide reference for China’s government.Methods The official websites were searched for information and related literature,and literature review was used.Results and Conclusion In foreign countries,the clinical value of innovative drugs and their impact on medical insurance funds were comprehensively evaluated based on factors such as quality-adjusted life years,clinical benefit,and improvement of clinical benefit.Then,the evaluation results were taken as an important basis for whether innovative drugs were admitted to the medical insurance catalog and establishing medical insurance payment standards.By using international experience for reference,innovative drug pricing methods and medical insurance payment standards for China’s national conditions can be improved by establishing a basic database of clinical value and drug economic evaluation of innovative drugs,as well as innovative drug payment models based on decision thresholds.

Research on Incentive Policies for Chinese Innovative Drug R&D - Taking Innovative Anti-tumor Drugs as an Example

Objective To provide reference for improving Chinese innovative drug research and development incentive policies.Methods Based on investigating the incentive policies for innovative drug research and development in clinical research,evaluation and approval in China,anti-tumor drugs were taken as the research object to discuss relevant policies from the perspective of clinical trials and registration approval based on data statistics and current situation analysis.Results and Conclusion Driven by a series of incentive policies for innovative drug R&D,great achievements have been made on anti-tumor drugs.However,there are problems such as concentration of drug targets,homogenization of clinical trials,and gaps in some drugs with large clinical needs.To improve incentive policies for innovative drug R&D,China should adhere to the orientation of clinical value,focusing on basic research and translational research,improving evaluation and approval capabilities,and establishing a sound ecosystem for innovative drugs.

The 5^(th) Annual Meeting of GP-TCM Research Association-cumSummit on Compendium of Materia Medica and Innovative Drug Discovery in Chinese Medicine

FIRST ANNOUNCEMENT9-10 August 2016Room 103,Dr.Hari Harilela Lecture Theatre,The Wing Lung Bank Building for Business Studies Hong Kong Baptist Universilty(Shaw Campus),34 Renfrrew Road,Kowloon Tong,Hong Kong'The 5th Annual Meeting of GP-TCM Research Association-cum-Summit on Compendium of Materia Medica and Innovative Drug Discovery in Chinese Medicine',jointly organised by GP-TCM Research Association,School of Chinese Medicine of Hong Kong Baptist University,and TCM Chemistry Specialty Committee and TCM Pharmaceutical Analysis

创新药品价值评价指标体系构建

目的 基于价值构建创新药品评价指标体系,以期为我国创新药品价值测评、有关部门基于价值对药品定价、遴选机制建设提供理论基础和实践依据。方法 主要采用文献调研法、专家咨询法进行研究。结果 第一轮专家咨询的积极系数为90.00%,第二轮为94.44%;第一轮专家咨询的权威系数为0.85;第一轮咨询一、二级指标的专家意见一致性系数分别为0.59、0.28(P<0.001);第二轮咨询一、二级指标的专家意见一致性系数分别为0.57、0.31(P<0.001)。最终构建的创新药品价值评价指标体系包括出5个一级指标、24个二级指标,一级指标及其权重分别为创新性(0.253 3)、有效性(0.254 0)、安全性(0.224 7)、经济性(0.156 0)、可及性(0.112 0)。结论 构建的创新药品价值评价指标体系具有较好的准确性、客观性与可靠性,为我国创新药品价值评测与合理定价奠定了一定的理论基础。

Evolution of drug regulations and regulatory innovation for anticancer drugs in China

Over the past two decades,China has introduced significant changes to drug regulations through regulatory innovations to accelerate drug review and approvals,keeping in line with the rapidly growing scientific innovation in drug research and development(R&D).In this study,we outlined the revolution of drug regulation in China since the establishment of the State Drug Administration in 1998.More particularly,we performed a comprehensive analysis of newly approved anticancer drugs in China from the year 2005 to May 2021,as a powerful illustration of how the revolution has changed the drug R&D landscape.Innovative drug development in China has boomed,benefiting in particular from pro-innovation policies as well as expedited program designations by the authority.We found a significant increase in the number of both imported and domestic new anticancer drugs from 2005 to 2021,with the emergence of drugs with novel mechanisms of action,including immune checkpoint inhibitors and cell therapy products.Drug lag has also been dramatically shortened by more than 70%for imported drugs in years 2016-2020 compared to years 2006-2010.Furthermore,we provide an insight into the potential approaches to further optimize the science-based and clinical value-based regulatory and R&D drug ecosystem in China.This review provides evidence of significant impacts of regulations and policies on drug R&D and suggests that the constantly adapting regulatory ecosystem will speed up drug development in China and worldwide.