Artificial intelligence (AI) has emerged as a transformative force in healthcare, with applications spanning diagnostics to drug development. However, its integration into drug regulation remains nascent, with varying degrees of adoption and implementation across different regulatory bodies worldwide. This review aims to provide a comprehensive overview of the current state of AI in drug regulation, encapsulating AI-related policies, initiatives, and its practical application in regulatory agencies globally. It further discusses the challenges and future prospects of AI in this field. The findings reveal that numerous agencies have launched action plans and initiatives to incorporate AI, aiming to streamline regulatory processes and enhance data-driven regulatory decision-making. Moreover, AI's deployment in safety surveillance, workflow optimization, and regulatory science research is expanding, highlighting its increasing impact on drug regulation. Nonetheless, key challenges persist, such as data quality and reliability, technical limitations, talent shortage and the absence of standards. The review concludes that interdisciplinary collaboration is crucial to harness AI's full potential in drug regulation and overcoming its current limitations. In the future, AI may become a pivotal catalyst in drug regulation, promising a new era of enhanced scrutiny, efficiency, and innovation that will benefit public health on a global scale.

Objective To understand the occurrence of catheter-associated urinary tract infection(CAUTI)in pa-tients with catheterization,and provide evidence for reducing the incidence of CAUTI.Methods Based on monito-ring requirement for CAUTI in competency building project of healthcare-associated infection(HAI)prevention and control established by Hospital Infection Management Committee of Chinese Hospital Association,CAUTI among patients who hospitalized and received urinary catheterization ≥2 days in a hospital from January to December 2014 were analyzed prospectively,incidences of CAUTI in different patients were compared.Results A total of 6 046 patients with urinary catheterization were monitored,166 of whom developed CAUTI,incidence of CAUTI was 2.75%,the total urinary catheter days were 31 833 days,incidence of CAUTI was 5.21 per 1 000 urinary catheter days.There was no significant difference in the incidence of CAUTI among patients of different genders (χ2 =1 .23, P =0.54);incidence of CAUTI in patients > 60 years old was higher than those ≤60 years (4.72% vs 2.07%,χ2=30.38,P <0.01);incidence of CAUTI in patients with different duration of catheterization was significantly dif-ferent(χ2 = 251 .14,P <0.01 );with the prolongation of duration of catheterization,incidence of CAUTI also in-creased(trendχ2 =211 .82,P <0.001 ).Patients in department of neurology had the longest average catheterization time(14.84 days)and highest incidence of CAUTI(15.00%,10.11 ‰);patients in the other departments of surgery had the shortest average catheterization time(3.56 days)and lowest incidence of CAUTI(0.97%,2.74‰);inci-dences of CAUTI in patients with urinary catheterization in different departments were significantly different(χ2 =302.24,P <0.001).166 CAUTI patients were isolated 66 isolates of pathogenic strains,86.36% were gram-nega-tive bacilli,33.33% of which were Escherichia coli .Conclusion CAUTI is related to the age of patients and dura-tion of indwelling urinary catheter.Daily assessment on the necessity of indwelling catheter and timely removal of catheter is helpful for reducing the occurrence of CAUTI.

Objective To observe the effect of clindamycin for preventive infection in arthroplasty prophylac-tic.Methods 108 knee replacement patients were injected by 600mg intravenous clindamycin preoperation and con-tinue to use 1 -2 days after operation.The average postoperative hospitalization,postoperative outcome,body tempera-ture and blood after WBC changes of CRP and ESR in the fall of superficial infection trend,the average postoperative day,take out stitches after operation and the number of cases,postoperative deep infection early after infection (2 weeks)and delayed infection cases (within one year)were observed in order to evaluate the efficacy of preopera-tive antibiotics.Results 2 cases had superficial infection due to wound dehiscence (two times after suture recover-y),there was no complications of surgical wound in the other cases.In all cases,after operation,body temperature and blood WBC became to the normal level in seventh days,postoperative patients'CRP,ESR monitoring were significantly higher than those before operation (CRP:F =105.32,P =0.045;ESR:F =118.47,P =0.039),but on the 5 day after operation they were started to decline,CRP in the 21 postoperative day gradually returned to normal,and ESR gradually returned to normal after 6 months of operation.Preoperative HSS score was significantly lower than the post-operative score[(46.8 ±9.7)points vs.(91.7 ±3.4)points,t =6.38,P <0.05].Conclusion Clindamycin plays a definite role in prevention of infection,especially in the beta lactam antibiotic allergy cases,it can be preoperative antibiotic prophylaxis instead of cephalosporins.