Objective: To investigate the implementation status of the Chinese Good Manufacturing Practice (GMP) Investigational Medicinal Products Appendix (hereinafter referred to as the "Chinese Appendix") since its release, to understand the problems existing in the implementation process, and to provide suggestions for effective implementation of the Chinese Appendix. Methods: The implementation status of enterprises in different provinces was summarized by means of online questionnaire and on-site investigation, and the implementation of relevant requirements and existing problems were analyzed. Results: There were 100 enterprises participating in the survey from 10 provinces, with a wide and representative product coverage. Research showed that most enterprises had already complied with the requirements of the Chinese Appendix, but a few enterprises had shortcomings in establishing quality management systems (8%), conducting collinear evaluations (9%), establishing the clinical trial drug files (15%), evaluating the similarity between control drugs and experimental drugs (10%), retaining samples (24%), and releasing (21%). Conclusion: It is recommended that the applicants earnestly fulfill their main responsibilities, implement the requirements of the Chinese Appendix and organize more professional training to improve the comprehensive level of enterprise personnel. The drug regulatory authorities should issue relevant guidances documents to conduct special inspections or sampling inspections of drugs used in clinical trials based on risks, and promote the implementation of the requirements of Chinese Appendix
Key words
good manufacturing practice /
investigational medicinal products appendix /
implementation status /
applicants /
special inspections
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