Research Progress and Suggestions on China’s Drug Registration Management Based on CiteSpace Knowledge Maps

Objective To analyze the research status and hot spots in the field of drug registration in China,and to provide some suggestions for the follow-up research.Methods CiteSpace was used to conduct literature quantitative analysis on 684 related articles from 2012 to 2022,and the knowledge map was drawn.Based on this,the main characteristics and development trends of the related studies were summarized.Results and Conclusion The number of articles published was closely related to the regulatory policy of drug registration reform.The authors of these articles did not have good continuity.Besides,research hot spots were closely related to the actual work,which was mainly around the improvement of the review and approval policy,encouraging innovative drug research and development,improving the level of new drug development and other directions.The follow-up studies should further strengthen the continuity of research and inter-agency collaboration.In addition,biomedical registration may become a new research focus in the future.

Analysis of Compliance Management Practice of American Drug Registration Applicants and Its Enlightenment to China

In order to achieve the goal of drug safety, effectiveness and quality control, corporate compliance management construction is significant. Therefore, this paper systematically analyzes the seven elements of compliance management for U.S. pharmaceutical manufacturers as described in the Compliance Program Guidance for Pharmaceutical Manufacturers issued by the HHS-Office of Inspector General, as well as further analyzes the implementation of the guidance by representative multinational companies in different drug registration stages. Finally, some suggestions and implications are proposed to strengthen the construction of compliance management for Chinese drug registration applicants based on the former practical experience.

Analysis and Enlightenment of Pediatric Drug Registration Data in China

Objective To analyze the current status of pediatric drug development in China from the perspective of pediatric drug registration and clinical trials so as to provide a reference for its improvement.Methods The registration and clinical trials explicitly labeled as pediatric drugs were analyzed by using the Insight Database,National Medical Products Administration(NMPA),and other publicly available information.Results and Conclusion The number of applications for pediatric drug registration was 196,and 104 were for domestic drugs,accounting for 53.06%.The number of pediatric drugs included in the priority review was 116,and 70.18%have completed the review.However,the number of new pediatric drug marketing applications is still not optimistic.Only 5 applications for pediatric drug registration are accepted by Center for Drug Evaluation(CDE),accounting for 4.63%.There are difficulties in recruiting pediatric subjects in clinical trials,with 42.08%of completed recruitment projects.Besides,there are few institutions for drug clinical trials,the distribution of institutions and professional certification are uneven.Therefore,enterprises should be encouraged to carry out research and development of pediatric drugs from two aspects:improving the policy for pediatric drugs and strengthening the clinical management of pediatric drugs to guarantee their safe use.

Integrating traditional Chinese (herbal) medicines into risk based regulation-With focus on non-clinical requirements to demonstrate safety

Within the public health sector of Hong Kong(China),there is a consensus around the important role of traditional Chinese medicines.For Hong Kong(China)to play a bridging role to bring Chinese medicines to the global market requires a concerted effort from the government,academic institutes and industries.The release of the final version of the European Medicines Agencies guidance document,which details the acceptance of minimum requirements to nonclinical package in bibliographical applications,grants the opportunity for well-established and traditional herbal medicines to demonstrate an‘acceptable safe’status for registration in the European Union.It is anticipated that this minimum nonclinical package can be applied to demonstrate the safe use of many traditional Chinese medicines regardless of their eligibility to be registered under the simplified procedure within the European Union.This paper conceptualizes an integration of a simplified evaluation route for eligible proprietary Chinese medicines(pCm)with long history of use into the existing drug regulatory framework in Hong Kong(China).Such integration utilizing the minimum nonclinical package,based on bibliographical data or expert report,as proof of evidence to demonstrate safety for pCm with long history of use requires less demand in scientific resources.With Hong Kong(China)conducting‘first hand’review for eligible pCm,it provides an option for overseas and local pharmaceutical companies to register their products in Hong Kong(China)without the need to rely on issuance of Certificate of Pharmaceutical Product from other countries.This could bring eligible pCm with long history of use to reach international risk-based standard and to be marketed globally as‘medicines’to reach their full therapeutic potential.An important process to positioning Hong Kong(China)to compete with other countries in promoting importation and exportation of pCm to better serve the global health.