Objective: This paper reviews and analyzes the practice of global drug regulatory cooperation and the internationalization process of drug regulation in China, and makes suggestions for China to join the Pharmaceutical Inspection Co-operation Scheme (PIC/S) as soon as possible to achieve mutual recognition in GMP inspection. Methods: According to the requirements of PIC/S for applicant authorities, in order to prepare for the evaluation of China's drug inspection authorities by PIC/S, this paper analyzes the current gaps in China's drug inspection system based on literature review, inspection status analysis and interpretation of PIC/S audit checklist indicators. Results and Conclusion: Joining PIC/S will help strengthen cooperation between regulatory authorities in various countries and achieve mutual recognition in GMP inspection, and further promote the internationalization of drug regulation in China. In order to successfully pass the formal evaluation of China's drug inspection authorities by PIC/S and become a member authority of PIC/S as soon as possible, China should carry out benchmarking work as early as possible in terms of improving GMP standards, optimizing inspection processes, improving inspector capabilities, and building quality systems for inspection authorities.

Objective: To provide reference for the internationalization of sterile medicinal products inspection in China by analyzing the GMP appendix of PIC/S "Manufacture of Sterile Medicinal Products". Methods: Through the analysis of the main contents of the PIC/S GMP sterile medicinal products appendix and the diff erences with the current GMP sterile medicinal products appendix in China, combined with the common problems in the manufacture inspection of sterile medicinal products in China, suggestions for improving the GMP inspection of sterile medicinal products in China were provided. Results and Conclusion: Compared with the existing GMP sterile medicinal products appendix in China, the revised PIC/S GMP sterile medicinal products appendix has been considerably updated in concept and content, refl ecting the progress of drug regulation with the times, suggesting that while standardizing inspection and improving the level of inspection, we should guide enterprises to take the initiative to understand the international advanced quality management concepts, move closer to the international level and international standards, and improve the overall level of China's sterile medicinal products manufacture industry.

Objective: For China to apply for joining the Pharmaceutical Inspection Co-operation Scheme (PIC/S), establish internationally unifi ed inspection standards, and put forward the diff erences that need urgent attention in GMP inspection of cell therapy products. Methods: The overall combing and comparative analysis of China's cell therapy product guidelines and the GMP appendix of PIC/S advanced therapeutic medicinal products were carried out, and some key issues were discussed. Results: The principles and considerations of China and PIC/S GMP appendix are basically the same, but they are diff erent from the regulatory system, framework structure, scope of application, and specifi c requirements. Conclusion: The enlightenment for GMP inspection of such products is proposed from three aspects: quality risk management, inspection of starting biological materials, and unifi cation with international inspection standards.

Objective: By analyzing the requirements of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) Good Manufacturing Practice (GMP) Guidelines and Real-time Release Testing (RTRT) Appendix, this paper provides ideas and suggestions for the development and application of real-time release testing technology in China's pharmaceutical industry. Methods: This paper conducts in-depth research on the GMP guidelines and RTRT appendices of PIC/S, and discusses the feasibility of RTRT in China's pharmaceutical industry and its enlightenment to China's drug regulation by combining relevant RTRT regulations and literature at home and abroad. Results and Conclusion: China's drug regulatory authorities should benchmark the relevant technical requirements of PIC/S as soon as possible, combine the pilot experience of parameter release and the development characteristics of China's pharmaceutical industry, and issue RTRT guidelines that meet national conditions to ensure the implementation of RTRT in China's pharmaceutical industry and lay the foundation for China to join PIC/S and better integrate with international standards.

Objective: To provide countermeasures and suggestions for improving the standardization and systematization of GMP inspection management in China and ability improvement of inspection and risk elimination by a comparative study of GMP inspection standards and guidelines in China and the Pharmaceutical Inspection Co-operation Scheme (PIC/S). Methods: Through literature research, the implementation of risk-based GMP inspection plans for drugs by PIC/S, European and American drug regulatory authorities was analyzed, and the path of implementing risk-based GMP inspection plans in China was explored. Results and Conclusion: The concept of formulating GMP inspection plans based on risk has been widely implemented in PIC/S, European and American drug regulatory inspection systems, and has formed a relatively mature model applicable locally, giving full play to the eff ectiveness of intensive inspection resources and eff ective investigation of hidden dangers. Based on the relevant requirements for inspection procedures in China's drug regulatory system, this paper analyzes the implementation status and challenges of risk-based GMP inspection plans in China, and puts forward countermeasures and suggestions from the aspects of formulating risk-based inspection plans, detailed inspection procedures, and ensuring inspection resources, so as to unify and standardize the operation mechanism and standards of drug inspection by drug regulatory authorities and improve the effi ciency of drug inspection.

Objective: To analyze the system and implementation effectiveness of foreign compassionate use, and the accessibility of compassionate medication system for rare disease patients in China, based on the current situation of drug accessibility for rare disease patients in China, and to propose the detailed rules of compassionate use system for domestic rare diseases patients. Methods: The regulations, policies, technical guidelines, relevant statistics and literature published by the US FDA were searched, and the use categories, application and approval processes, fees and payment methods by consulting the regulations and policies, technical guidelines, relevant statistics and literature published by FDA were analyzed. Results and Conclusion: The United States has a relatively complete system of compassionate use. The establishment of this system in China may become a new path for domestic rare disease patients to obtain medication, and to a certain extent, it could improve the drug availability of domestic rare disease patients.