Drug regulatory science is a cutting-edge task in the field of drug regulation that has received much attention from the international community in recent years. Currently, different countries and regions have different foundations for drug regulatory industries, are in different stages of development, and face different prominent issues. Therefore, the focus of drug regulatory science and the problems that need to be solved are also different. The origin of drug regulatory science suggests that we should deeply consider the emergence and development of drug regulatory science from the perspective of the arrival of a new era and the emergence of new forces. The definition and characteristics of drug regulatory science suggest that it is a practical science that solves prominent problems and directly serves regulatory decision-making, and future studies should focus on drug regulation rules, develop new regulatory tools, standards and methods, and cultivate new theories, regulations and mechanism.

Fumagillin is a natural insoluble antibiotic isolated and purified from the liquid fermentation medium of Aspergillus fumigatus. Fumagillin and its derivatives have been found to have a variety of biological activities such as anti-tumor, anti-obesity and anti-microsporidiosis, so they are widely used in the field of medicine. The molecular structure properties, biological activity, application and mechanism of action of fumagillin and its several common derivatives based on C6 site modification, such as fumagillin B, TNP-470, CKD-732 and PPI-2458 are reviewed in this article, and the separation and purification process, activity research and application prospect are prospected in order to provide reference for the further application of low toxic fumagillin and its derivatives in clinical practice and research.

Objective: To conduct a research on the current difficulties in the design, evaluation, and implementation of clinical trials of pediatric Chinese medicine and build a list of questions for the development of the Expert Consensus on Issues Related to Clinical Trials of Pediatric Chinese Medicine. Methods: The parties involved in clinical trials of pediatric Chinese medicine were surveyed by online questionnaires to learn the difficulties in the design, evaluation, and implementation of clinical trials. Results: A total of 49 questionnaires were collected, and the experts believed that it was difficult to determine the indications, test purpose, diagnostic criteria, age range, control drugs, efficacy and safety evaluation in the design and evaluation stage of clinical trials of traditional Chinese medicine for children, and there was a lack of scientific basis for developing medication regimen. In the implementation phase, the start time of the trial should be specified, and further improvement should be made in the aspects of ethical review, subject recruitment, informed consent, compliance, and DMC setting. Conclusion: There were many difficulties in the design, evaluation, and implementation of current clinical trials of pediatric Chinese medicines, which should be improved from various aspects such as policy, awareness, and technology, thus to promote the research and development of pediatric proprietary Chinese medicines.

Oil APIs for injection extracted from animals and plants mainly used in fat emulsions. Based on the requirements of relevant regulations, guidelines, and review experience in recent years, this paper expounds some considerations on the study of oil APIs for injection extracted from animals and plants, including starting materials and process control, impurity control, validation of virus inactivation/removal process, quality research, etc, in order to provide some references for future research．

Objective: Drug resistance and endogenous cross-reactivity are the main factors affecting the detection of anti-drug antibody (ADA), so the establishment of method that can tolerate higher drug concentration and avoid endogenous cross-reactivity is a major problem to be solved in immunogenicity analysis. The aim of this study was to establish and verify a method for detection of ADA against recombinant human serum albumin (rHSA). Methods: Anti-rHSA antibody was extracted by acidification and enrichment with magnetic nanobeads and then detected using a bridging method. Finally, the established method was validated. Results: The recovery of the antibody was greater than 80% by using the established method. The sensitivity of the method could reach 0.5 μg·mL^-1 and the intra- and inter-batch RSDs were less than 20%. In addition, the method could resist drug of up to 2 mg·mL^-1. Conclusion: This study established a method for the detection of anti-rHSA antibody. The method has high antibody recovery and good performances of sensitivity and precision. It can also achieve mg-level drug-resistance and effectively remove the interference of endogenous substances, which can be applied for the detection of ADA, extraction of antibody drugs and further analysis of drug metabolism.

Objective: To observe the effect of Xiangpishengji Ointment on the wound surface model of small Bama pigs, preliminarily observe the effect of Xiangpishengji Ointment on the VEGF-Notch signaling pathway in the wound surface of experimental pigs, compare the difference in wound healing between experimental pigs and rodents, and explore the rationality of selecting experimental pigs for the development of wound surface model. Methods: A total of 48 sores were prepared on the back of 4 small Bama pigs and divided into 2 groups, namely the Conwell hydrogel group and the Xiangpishengji Ointment group. Photos were taken on the 0, 7 and 14 days after surgery. Image J software was used to measure the wound area, calculate the wound healing rate, record the wound healing time, and observe the pathological changes with HE staining. The expression of VEGF-Notch signaling pathway related factors in wound tissue was detected by immunohistochemistry. Results: Xiangpishengji Ointment could promote the wound healing of experimental pigs, improve the wound healing rate, shorten the healing time, and promote the expression of VEGF-Notch signaling pathway related factors. Conclusion: Xiangpishengji Ointment can promote the healing of small Bama pig wound model, which may be related to the influence on VEGF-Notch signaling pathway. Experimental pigs are more similar to humans than rats in physiological and pathological aspects, and may become an accurate model for wound healing exploration in the future.

Objective: To study the stability of hepatocyte growth-promoting factor for injection (HGFI) and its compatibility with different material infusion sets by physical and chemical testing and cell experiment. Methods: HGFI was dissolved with different solvents. Then the solution was sampled at 0 h and 24 h with or without infusion tube made of polyvinylchloride (PVC), thermoplastic elastomer (TPE), of thermoplastic polyurethanes (TPU) to determine the pH value, protein, clarity, visible foreign bodies, insoluble particles, osmolarity, content and macromolecular substances. HGFI was dissolved with 5% glucose injection or normal saline for 0 h and 24 h, and then diluted with complete medium and co-incubated with rat liver cells (BRL) for 48 h. The cell viability was detected by CCK-8 method. Results: The pH value, protein, degree of clarification, visible foreign bodies, insoluble particles, osmotic molar concentration, content determination, and macromolecular substances of HGFI dissolved with 5% glucose, normal saline, 5% glucose and normal saline and sampled via/not via infusion tube of different materials (PVC, TPE, TPU) at 0 h and 24 h all met the requirements of 2020 edition of Chinese Pharmacopoeia. Compared with the normal control group, HGFI solutions at 0 h and 24 h not only had no toxic effects on BRL cells, but also significantly increased the viability of BRL cells. Conclusion: HGFI is stable within 24 h with different solvents and has good compatibility with infusion sets of different materials. Moreover, it keeps wonderful bioactivity within 24 h.

Objective: To evaluate the anti-platelet aggregation effect and advantages of Quansanqi tablets (PSQ), an innovative new drug of Panax notoginseng. Methods: Human platelet-rich plasma and washed platelets were used to detect the platelet aggregation rate and calcium ion concentration induced by different platelet activators; rat platelet-rich plasma was used to compare the platelet aggregation rate induced by ADP in PSQ and Panax notoginseng extract; gastric bleeding model rats were established by injecting 80% ethanol to investigate the effects of PSQ and aspirin on fecal occult blood; the hemostatic effect of PSQ was observed by mouse and rat coagulation test. Results: PSQ could dose-dependently inhibit ADP, thrombin, U46619, collagen and reduce anti-CD9-induced human platelet aggregation rate (P<0.01) and Ca²⁺ release (P<0.05 or P<0.01); it could inhibit ADP-induced rat platelet aggregation rate (P<0.01), with significantly better effect than Panax notoginseng extract. PSQ could reduce the fecal occult blood grade in gastric bleeding model rats (P<0.05), while aspirin could not (P>0.05); it could also significantly shorten the coagulation time in mice and APTT time in rats, indicating certain hemostatic effect. Conclusion: PSQ has significant anti-platelet aggregation effect through multiple ways with multiple action targets, and can also reduce the risk of bleeding because of its excellent hemostatic effect, which is a safe and effective new antiplatelet drug.