Training and practice for drug inspectors in China: experiences, challenges, and developments

被引:0
作者
Sun, Jinyao [1 ]
Guo, Lubo [2 ]
Shi, Zhixiang [3 ]
Wu, Fang [4 ]
Zhang, Yongze [1 ]
机构
[1] China Pharmaceut Univ, Sch Continuing Educ, Dept Training, Nanjing, Peoples R China
[2] Jinan Cent Hosp, Dept Pharm, Jinan, Peoples R China
[3] China Pharmaceut Univ, Sch Foreign Languages, Dept Pharmaceut English, Nanjing, Peoples R China
[4] China Pharmaceut Univ, Sch Int Pharmaceut Business, Dept Business Adm, Nanjing, Peoples R China
关键词
China; drug regulation; drug inspector; practice; present and future; training;
D O I
10.3389/fmed.2025.1571922
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
The professional level and inspection ability of drug inspectors directly determine the quality of inspection and affect drug safety. Drug inspectors need to guarantee that they can effectively perform their duties and better provide reliable supervision by receiving strict qualification authentication, systematic professional training, and standardized behavior management. This paper highlights the current situation of training and practice for drug inspectors in China, particularly the development and achievements in recent years, and examines the current challenges and opportunities facing the drug inspector training system in China and proposes some recommendations for improving the drug inspector training system, aiming to provide some insights for improving the overall quality and modernizing the inspection abilities of drug inspectors in China.
引用
收藏
页数:11
相关论文
共 53 条
[1]  
Center for Food and Drug Inspection of NMPA, 2024, Organizational structure
[2]  
Center for Food and Drug Inspection of NMPA, 2021, CFDI participate in the second PIC/S control of cross-contamination in shared facilities (CCCISF) seminar
[3]  
Center for Food and Drug Inspection of NMPA, 2024, The second training for production inspectors of the WHO national regulatory authority (NRA) for vaccines was successfully held
[4]  
Center for Food and Drug Inspection of NMPA, 2021, Announcement on the issuance of five documents including the 'drug registration inspection procedures (trial)
[5]  
Center for Food and Drug Inspection of NMPA, 2021, CFDI organized a special training for vaccine inspectors and vaccine resident inspectors in 2021
[6]  
Chen H., 2021, Zhongguo Ya Shi, V35, P221, DOI [10.16153/j.1002-7777.2021.02.015, DOI 10.16153/J.1002-7777.2021.02.015]
[7]  
Chen X., 2023, China Food Drug Adm Mag, V7, P104, DOI [10.3969/j.issn.1673-5390.2023.07.013, DOI 10.3969/J.ISSN.1673-5390.2023.07.013]
[8]  
Chen Y., 2002, Research on the development process of GMP in China
[9]  
China Center for Food and Drug International Exchange, 2022, 2021 annual drug inspection work report issued by center for food and drug inspection of NMPA
[10]  
China Food and Drug Network, 2022, The digital empowerment Tianjin drug and cosmetics inspector training management system has been officially launched and put into operation