Research On The Current Status And Countermeasures Of Stem Cell Clinical Research Supervision In China

Objective:To systematically sort out the development and supervision of stem cell clinical research in China,to clarify the model and system of stem cell clinical research supervision,mainly including the basis,subject,object,procedure and content of supervision,to summarize the effectiveness and problems of supervision,and to draw on the experience of typical countries' stem cell clinical research supervision,to propose countermeasures to improve the supervision of stem cell clinical research in China.Method:Using the methods of literature research,expert consultation,and field investigation.Using the literature research method to systematically collect,organize and analyze policies,papers related to the development and supervision of stem cell home and abroad to understand the status of the development and supervision of stem cell clinical research home and abroad.Inviting stakeholders of stem cells clinical research that including scientist,ethicist,quality control personnel,managers of medical institutions,experts in charge of the health administration department and relevant scholars.Understanding the status,effectiveness,problems and suggestions of the supervision of stem cell clinical research through in-depth interviews and seminars.Understanding the process and conditions of stem cell clinical research in medical institutions through field surveys.Result:1.Stem cell clinical research in China is developing rapidly,but in retrospect,it has experienced many changes,twists and turns,especially in terms of regulation: regulatory environment was relatively loose,and various institutions scrambled to carry out related research before 2009 in our country.There are chaos and non-standard applications that some medical institutions have carried out,which has aroused international and social criticism.Since 2009,the government has tightened supervision and managed autologous stem cells according to "the third type of medical technology",allowing medical institutions that have passed the audit to conduct related applications.Until 2015,the third type of medical technology access approval was cancelled,and no institutions were approved to carry out the clinical application of autologous stem cells.With the "Stem Cell Clinical Research Management Measures(Trial)" and "Cell Therapy Product Research and Evaluation Technology The “Guiding Principles(Trial)” was separately issued in 2015 and 2017,the regulatory focus of stem cell was clarified,and the supervision of stem cell clinical research entered a standardized stage.Stem cell clinical research institutions and projects were orderly filed,new drug clinical trials were reaccepted,and the state increased investment in stem cell research,and various major carriers were rapidly established and developed.2.With the clarity of stem cell supervision,China currently adopts the dual-track supervision model: reporting to medical and health departments as medical technology and filing applications for drugs(therapeutic biological products)to the drug regulatory department.The former is mainly initiated by medical institutions,with scientific research as the main purpose,and has not yet been explicitly applied for transformation,and it cannot be charged;the latter is mainly initiated by pharmaceutical companies,with product listing as the main purpose.3.Stem cell clinical research supervision system is gradually improved,and the management mechanism of stem cell clinical research is continuously improved: the responsibilities of the health administrative departments and drug supervision and administration,which the state and local governments were further clarified.The country and local management leading groups and expert committees were successively established.The relevant qualifications and requirements of the medical institutions and personnel carrying out clinical research were further refined.The relevant industry organizations were also deeply involved in the regulatory standard formulation and specific regulatory process.Relevant policies,industry standards and ethical requirements of stem cell clinical research are being accelerated,regulatory basis and policy system are constantly improved.4.On the whole,China's supervision of stem cell clinical research has achieved effects.Medical institutions have strong standardization and enthusiasm in carrying out projects,and the research projects are growing rapidly,which also promotes the rapid development of stem cell field in China.But currently,there are still many problems in the supervision of stem cell clinical research: the imbalance between the development and demand of stem cell clinical research,the lack of effective connection within the supervision mode,the lack of effectiveness and operability of the supervision basis,the unclear rights and responsibilities of the supervision subject,the lack of supervision ability,the incomplete coverage of the supervision object,the lack of risk-based classification and classification management in the supervision process,the efficiency of project filing and approval is low,and the lack of supporting support and social supervision.Conclusion:The dual-track regulatory model and multi-department,multi-level and multi-party regulatory system have promoted the rapid development of stem cell clinical research,but there are still many problems need to be improved urgently.It is suggested that China should strengthen the formulation of development plans for clinical research of stem cells at the national level,establish independent or cooperative review departments with clear responsibilities,formulate operable regulatory rules,establish a classification and grading management mechanism and a hierarchical feedback system for review opinions,clarify the internal connection and transformation path of the regulatory model,and improve the regulatory safeguards for clinical research of stem cells.The competent department of health administration strengthens supervision,adds a third-party quality review and inspection institution for stem cell preparations,guides the public to participate in the supervision,and improves the supervision ability of government.