In recent years, China's drug regulatory authorities have implemented the "four strictest" requirements, deepened the reform of the evaluation and approval system, and continuously promoted regulatory innovation. Drug regulatory agencies in various provinces and cities continue to strengthen their drug regulatory capacity building. Recently, the National Medical Products Administration issued the "Measures for Supervision and Inspection of Drug Clinical Trial Institutions (Trial)", which clearly states that the National Medical Products Administration is responsible for formulating a supervision and inspection system for trial institutions, guiding provincial drug regulatory departments to carry out supervision and inspection of trial institutions, and organizing supervision and inspection of trial institutions as needed.
Clinical trials of drugs, as the main means of evaluating drug safety and effectiveness, are an important part of ensuring the safe use of drugs by the people. Drug regulatory bureaus in various provinces and cities should implement this policy in conjunction with the actual situation in their respective regions.
Beijing Bureau: Beijing Tianjin Hebei Linkage, Integration of Decentralization, Management and Service
In recent years, Beijing has vigorously promoted the development of innovative drugs, innovative medical devices, and health services. At present, there are 67 registered clinical trial institutions for drugs in Beijing (excluding military medical institutions), 778 registered specialties, and 3337 main researchers. The Beijing trial institutions have undertaken a large number of drug clinical trial projects, showing a growing trend year by year. In 2022, there was a year-on-year increase of 17.8% compared to 2021. Among them, innovative drug projects increased by 12.5% year-on-year, covering many disease fields such as cardiovascular disease and malignant tumors.
In terms of improving system construction, the Beijing Municipal Drug Administration has successively formulated and implemented work documents such as the "Supervision and Inspection Procedures for Drug Clinical Trial Institutions and Drug Non clinical Research Institutions" and the "Handling Procedures for Drug Registration Verification Results", and strictly followed their implementation. Based on this management system, a long-term regulatory mechanism has been established with linkage at all levels and a combination of decentralization, management, and service. The powers of regulatory agencies at all levels have been clarified, and a clear, orderly, unified, and efficient regulatory operation mechanism has been formed. Since the initiation of daily supervision in 2014, more than 550 drug clinical trial institutions have completed daily supervision and inspections.
In terms of unified inspection standards, the Beijing Municipal Medical Products Administration, together with the Tianjin Municipal Medical Products Administration and the Hebei Provincial Medical Products Administration, jointly issued the "Daily Supervision and Inspection Standards for Drug Clinical Trial Institutions in the Beijing Tianjin Hebei Region" in 2021, improving the construction of the standard system in the field of drug clinical trial supervision. This inspection standard is the first regulatory standard jointly issued by the Beijing Tianjin Hebei region. It is not only an important measure to effectively implement the State Council's comprehensive strengthening of drug regulatory capacity construction and serve the high-quality development of the industry, but also a beneficial exploration to build and improve the collaborative development standard system in the field of drug regulation in the three regions. It has a positive demonstration effect on deepening regional regulatory collaborative development.
In terms of implementing scientific development, in order to standardize the management of basic clinical trial data and fully serve hierarchical supervision, the Beijing Municipal Medical Products Administration has established a drug clinical trial institution supervision information system in 2021 by utilizing the existing drug data management platform. The regulatory level of the institution is determined by the system's quantitative score and dynamically displayed, and the regulatory department determines the inspection strategy according to requirements.
In terms of innovative regulatory models, the Beijing Municipal Drug Administration has optimized resource allocation, promoted risk rating, and improved regulatory efficiency. In 2021, it issued the "Beijing Drug Clinical Trial Institutions Grading Supervision and Management Regulations (Trial)". Based on factors such as project implementation, ethical review, quality management system operation, and administrative supervision, the Beijing Municipal Drug Administration has applied risk management methods to implement targeted graded management of institutions. In addition, in order to implement the tasks and requirements of the "Two Zones" construction and the "14th Five Year Plan", improve clinical trial efficiency, and promote drug research and development, the Beijing Municipal Medical Products Administration has developed the "Implementation Plan for Decentralized Clinical Trials (DCT) Pilot Work", selected 10 trial institutions, and organized the implementation of DCT pilot work in the country. By coordinating and integrating the resources of experimental institutions with DCT research foundation in Beijing, and within the scope of obtaining clinical trial approval from the Drug Review Center, we explore the use of remote intelligent technology to carry out DCT projects in digital scenarios.
At the same time, in order to further improve the clinical research level of medical institutions in Beijing, strengthen the original innovation and industrial support capabilities of medical institutions, assist industrial development, and promote the construction of research-oriented wards and hospitals, the 30 demonstration construction units and research-oriented hospitals for research-oriented wards in Beijing that have been publicly announced are all registered drug clinical trial institutions. At present, the Beijing Municipal Drug Administration is actively participating in the drafting of measures and policies related to improving the clinical research level in Beijing, in order to fully leverage the demonstration and driving role of research-oriented ward construction, better meet the health needs of the people in the capital, and help the high-quality development of the Beijing pharmaceutical and health industry.
Next, the Beijing Municipal Drug Administration will carry out a series of work in accordance with the newly released "Supervision and Inspection Measures for Drug Clinical Trial Institutions" and "Inspection Points and Determination Principles". Firstly, establish and improve the supervision and inspection system for drug clinical trial institutions, adjust and optimize relevant work procedures as required, and comply with them. Secondly, targeted training should be provided to provincial inspectors and testing institutions to implement document requirements, strengthen inspector capacity building, and improve the quality management level of testing institutions. In addition, we will implement the relevant requirements of the new regulations and continue to promote the informatization construction of supervision and inspection work. Based on the construction platform of the "Three Medical Linkages" drug lifecycle system in Beijing, optimize and upgrade the clinical trial supervision system, fully serve supervision, improve efficiency, effectively supervise trial institutions to strictly implement plans and fulfill work responsibilities, protect the rights and safety of subjects, and ensure the authenticity, accuracy, completeness, and reliability of trial data and results.
Shanghai Bureau: Strong Supervision and Excellent Services
Shanghai has abundant clinical resources and high research enthusiasm. There are 64 registered trial institutions (excluding 4 military hospitals) under the jurisdiction of the Shanghai Municipal Medical Products Administration, with over 750 professional groups and over 2000 main researchers. In recent years, the clinical trial projects of new drugs under development in Shanghai have been increasing year by year, with a year-on-year increase of 21% in 2022 compared to 2021; The proportion of clinical trial project leaders in local institutions is relatively high, which provides a good resource and environment for the development of the biopharmaceutical industry.
In recent years, the Shanghai Food and Drug Administration has taken "strong supervision and excellent services" as the lead to carry out relevant work on drug clinical trial institutions in this city. One is to strictly supervise and effectively fulfill the daily supervision responsibilities of provincial government agencies. Develop an annual regulatory work plan, combined with initial supervision and inspection, joint verification, observation and inspection, to carry out daily supervision of full coverage inspections of drug research and development institutions in Shanghai; Develop system documents such as the General Operating Procedures for Supervision and Inspection of Drug Clinical Trial Institutions and the General Operating Procedures for First Supervision and Inspection of Drug Clinical Trial Institutions in Shanghai, unify inspection procedures, and standardize inspection behavior.
The second is to implement scientific supervision, risk oriented, and establish a classified supervision model. For problems discovered during inspection and rectification, collective comprehensive evaluation shall be adopted to assess risks one by one, and classified and graded control measures shall be implemented. If no serious non-compliance or systematic problems are found, daily supervision shall be implemented according to the regulatory work plan; For those with systemic issues, the responsible leaders will have face-to-face interviews with key personnel such as legal representatives and institutional leaders, requesting the suspension of new clinical trials and strict supervision of rectification. Institutions that have been interviewed and requested by the National Medical Products Administration to strengthen daily supervision will be included in the list of key daily supervision for the next year, with an increase in supervision frequency of once every six months.
The third is to strengthen the promotion of regulations and technology among practitioners, and further enhance the standardization and quality awareness of clinical trial personnel. Since the beginning of this year, the Shanghai Food and Drug Administration has collaborated with the Shanghai Municipal Health Commission, the Shanghai Drug Evaluation and Verification Center, and other relevant clinical trial committees such as the Shanghai Pharmaceutical Association and the Shanghai Pharmacological Society to focus on creating the "GCP Training Weekend Series" courses. In addition, we will actively promote the joint efforts of the Shanghai Municipal Commission of Science and Technology, the Health Commission, and the Economic and Information Commission to promote the professional titles, project proposals, performance evaluations of clinical trial practitioners, as well as introduce supportive and encouraging policies for funding rewards for the launch of innovative drugs.
Next, the Shanghai Municipal Drug Administration will take multiple measures to implement the relevant measures of the National Bureau. One is to carry out comprehensive publicity and training for all staff. According to the deployment arrangement of the National Bureau, actively participate in special training. At the same time, encourage and support relevant industry organizations in this city to incorporate the contents of the Measures, supporting inspection points, and judgment principles into their daily training. The second is to issue relevant documents. Recently, the Shanghai Municipal Health Commission has been leading the drafting of the Guiding Opinions on Strengthening the Clinical Research System and Capacity Building in the City to Assist the Development of the Biomedical Industry. The Shanghai Municipal Drug Administration has taken the initiative to provide suggestions and take the lead in improving the quality of clinical trials aimed at product registration, forming an implementation plan, linking multiple departments in the city, and implementing mechanisms for illegal and irregular disposal in clinical trial institutions, as well as information warning and supervision We have launched a series of implementation measures, including the mechanism for reporting inspection results and exploring the application of negative inspection results in the hospital's assessment index system. We will take multiple measures to jointly optimize supervision and promote the high-quality development of clinical trials.
In June 2022, Shanghai issued the Implementation Opinions on Comprehensively Strengthening the Construction of Drug Regulatory Capacity, which aimed to strengthen the bottom line of drug safety and promote high-quality development of the industry by focusing on national major strategies, continuously promoting reform and innovation, promoting service-oriented regulatory concepts, and continuously improving the governance system, We have planned and systematically deployed for the comprehensive upgrading of Shanghai's drug supervision and management capabilities. It is particularly emphasized to strengthen the capacity building of the regulatory team, improve the quality of the regulatory team, and plan to cultivate high-level, international evaluators, inspectors, and other content. Over the past year, the implementation has achieved significant results, especially in strengthening the construction of a professional and specialized team of drug inspectors.
One is to establish regulations and systems. The revised and issued "Shanghai Professional and Professional Drug Inspectors Team Construction Supporting Management System (Trial)", including the Shanghai Professional and Professional Drug Inspectors Grading and Classification Management Measures, Job Admission and Exit Management Measures, Allocation and Use Management Measures, Assessment and Evaluation Measures, Professional Ethics Standards and Code of Conduct and other supporting management systems, further standardizing the management of the inspector team.
The second is to enrich one's strength. The organization has carried out the verification, selection, and appointment of inspectors. As of now, Shanghai's municipal level inspectors have covered the drug regulatory bureau system, various district market bureaus, relevant clinical trial institutions, research institutes, and other units, including 3 sequences and 11 types of examinations, with a scale of 1062 (including 106 GCP inspectors), further enriching the inspector team.
The third is to enhance abilities. Continuously strengthen education, training, and job training, and enhance the comprehensive quality of inspectors through multiple channels. Sort out and identify 25 inspector training bases and 1 teaching base; Organize an average of 20 graded and classified training programs for inspectors each year, with 50 shifts, and an average of 4000 trainees per year; Focusing on new products, new technologies, new formats, and the characteristics of the local biopharmaceutical industry, we have organized high-quality training courses for four consecutive years to accurately cultivate inspectors who are urgently needed for supervision; Taking advantage of the opportunity provided by the National Medical Products Administration to promote participation in the PIC/S (Drug Inspection Cooperation Program), we will develop an international GMP inspector capability enhancement project plan and organize the first international GMP inspector training course, piloting the training of international inspectors; Increase the intensity of job rotation training, establish a medium - and long-term cross training mechanism for inspectors and law enforcement officers, adhere to diversified training methods such as "topic+", "standard+", and "digital+", organize and carry out various meritorious competitions, technical training, and excellent case selection activities, promote practice through comparison and application, and enhance the practical ability of inspectors.
Shandong Bureau: Jointly Grasp and Manage, Hold the First Pass of Drug Quality
Shandong Province is a province with abundant medical resources, with over 80 clinical trial institutions in the province; Shandong is still a major province in the pharmaceutical industry, with strong demand for clinical trials. As a provincial-level drug regulatory department, the Shandong Provincial Drug Administration not only needs to strictly implement its regulatory responsibilities, ensure the quality and safety of clinical trials, and uphold the first priority of drug quality, but also insists on integrating supervision into services, guiding the improvement of clinical trial capabilities, and serving the innovative development of the pharmaceutical industry.
Starting from December 1, 2019, China implemented filing management for drug clinical trial institutions, further simplified admission procedures, unleashed policy vitality, and achieved significant results. After more than three years of exploration and practice, various regions have initially formed mechanisms and measures for the supervision of drug clinical trial institutions. The National Medical Products Administration has timely solidified effective experience and practices in various regions, issued and implemented the "Supervision and Inspection Measures" and "Inspection Points and Determination Principles", which will undoubtedly have a profound impact on strengthening the supervision of clinical trial institutions and promoting the high-quality development of clinical trials.
The Measures further clarify the responsibilities of all parties, highlight the main responsibilities of clinical trial institutions and researchers, scientifically define a regulatory responsibility system that is coordinated and unified with the guidance of the National Medical Products Administration, supervision and evaluation by the Audit and Inspection Center, and inspection and inspection by provincial drug regulatory departments. At the same time, it further reflects the regulatory concept of "equal emphasis on system and project". The Measures further clarify the classification of inspection situations of experimental institutions (first inspection after filing, daily inspection, causal inspection, and other inspections), optimize the supervision and inspection procedures and the connection mechanism of inspection and inspection, especially regarding the handling of different inspection results, and provide policy basis for local regulatory authorities to strictly supervise and inspect and regulate their behavior.
The Inspection Points and Judgment Principles provide specific operational inspection basis and technical guidance for drug regulatory authorities at all levels to carry out supervision and inspection of drug clinical trial institutions under the requirements of new regulations. The Inspection Points and Judgment Principles systematically sort out the conditions (filing requirements), operational management (in-process and post event), and other provisions of clinical trial institutions from the dimensions of institutions and specialties. Based on safety risks, defect classification is carried out, and the systematic principle of determining supervision and inspection results is clarified. This is beneficial for strengthening the capacity building of clinical trial institutions, strengthening the regulatory awareness of practitioners, and promoting the standardization of clinical trial institutions, All will play an important driving role. It can be foreseen that in the next step, the focus of supervision and inspection work in various regions will be more prominent, the standard scale will be more unified, and the result judgment will be more scientific and rigorous.
Next, the Shandong Provincial Drug Administration will take the implementation of the Supervision and Inspection Measures, Inspection Points and Determination Principles as an opportunity. Firstly, it will strengthen institutional construction, study and formulate implementation rules, and improve the supervision and inspection system; The second is to strengthen institutional supervision and inspection, complete clinical trial project verification with high quality, and promote the integration and unity of system inspection and project verification; The third is to strengthen the construction of inspection capabilities, implement the "Excellent Plan" for talent training, smooth the path of "professionalization" development, and accelerate the construction of a team of inspectors mainly composed of full-time inspectors and supplemented by clinical experts; The fourth is to strengthen the construction of the responsibility system, further strengthen collaboration and linkage with the health department, implement the institutional supervision information notification system, and establish a good pattern of joint management of "drug supervision and health supervision" on the basis of implementing institutional main responsibilities.
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