The “Drug Administration Law of the People′s Republic of China” has undergone two revisions and two amendments since its promulgation in 1984. The process of institutional evolution reflects the continuous deepening of understanding of drug administration courses, the continuous refinement of governance systems, the continuous improvement of governance mechanisms, the continuous enrichment of governance methods, and the continuous improvement of legal liability systems. The revision of the drug administration law in 2019 adheres to political guidance, problem-oriented approach, international perspective, national conditions, reform and innovation, and scientific development. The promulgation and successive revisions of the drug administration law reflect the changes in China′s economic, social, and pharmaceutical industry development, fully reflecting the growing health needs of the people and clearly demonstrating the comprehensive progress of China′s social governance. To advance drug safety on the track of modern rule of law, it is necessary to accurately grasp the historical position, improve the legal system, establish law enforcement authority, enhance legal literacy, and provide more solid legal system underpinnings for accelerating China′s leap towards becoming a pharmaceutical manufacturing powerhouse.

To review the evolution and changes of the drug manufacturing supervision system since the promulgation of the “Drug Administration Law of the People′s Republic of China” 40 years ago. The literature research method was used to retrieve laws, regulations, and supporting documents after 1985, and to review key institutional elements such as drug regulatory system, drug manufacturer license, GMP certification and inspection, inspector management, and commissioned production. The reform includes the drug production license simplified and optimized, and the system of drug supervisors and GMP inspectors has been upgraded to professional and specialized inspectors. GMP certification has been transformed into dynamic GMP inspection, and the scope of drug commissioned production management has gradually expanded. Over the past forty years, the drug manufacturing management system has adapted to and led the development of China′s pharmaceutical industry, achieved institutional updates and iterations, and promoted high-quality development of the industry.

Since the enactment of China′s first “Drug Administration Law of the People′s Republic of China” in 1984, China has entered a phase of legal and standardized drug management. The drug regulatory authorities have continuously strengthened the construction of the legal and regulatory framework for drug supervision and have optimized the drug review and approval system. The accessibility of drugs for rare diseases is a significant challenge worldwide. To meet the medication needs of patients with rare diseases, China has introduced a series of incentive policies to fully support the development of drugs for rare diseases and accelerate their review and approval. This paper systematically reviews the historical evolution, development process, and reform achievements of China′s rare disease drug review and approval system, and looks ahead to the future, aiming to further optimize the system to better meet the medication needs of patients.

Supramolecular gel is a three-dimensional network system formed by self-assembly through non-covalent interactions. Due to its good biocompatibility, stimulus responsiveness, coagulation-sol mutual denaturation and self-healing properties, there have been a lot of reports in the field of drug delivery and biomaterials in recent years. Based on the formation principle of supramolecular gel, this paper summarizes the research status of supramolecular gel in the field of drug delivery to provide reference for the future research of new drug delivery system with supramolecular gel as carrier.

Helicobacter pylori (H. pylori) is a microaerophilic, Gram-negative bacterium that colonizes the gastric mucosa and exhibits a distinctive spiral morphology. It was found to be involved in the development of diseases such as gastritis, peptic ulcers, and gastric cancer in 1982. Currently, H. pylori infection affects more than half of the global population, and the emergence of antibiotic resistance poses a significant challenge. Consequently, there is an urgent need for novel therapeutic agents capable of overcoming H. pylori resistance. This review provides a concise overview of the pathogenic mechanisms associated with H. pylori while summarizing and discussing both approved pharmaceuticals and investigational drugs targeting this bacterium, with the aim of facilitating the advancement of subsequent therapeutic agents targeting H. pylori.

OBJECTIVE To establish a method for the pharmacognostic identification and digital characterization of the Vicatia thibetica de Boiss and its similar species. METHODS The original plant specimens of Vicatia thibetica de Boiss. and its similar species, and carried out pharmacognostic studies and digital characterization of morphologic characteristics, character identification, microscopic identification using digital camera, body microscope, light microscope, and digital imaging systems were collected and made. RESULTS Taxonomic checklists of morphologic characteristics, character identification and microscopic identification were established for the Vicatia thibetica de Boiss and 7 similar varieties [Sphallerocarpus gracilis (Bess.) K.-Pol., Pleurospermum hookeri var. thomsonii C. B. Clarke, Angelica acutiloba (Sieb. et Zucc.) Kitagawa, Pleurospermum franchetianum Hemsl., Ligusticum daucoides (Franch.) Franch., Heracleum millefolium Diels, Anthriscus sylvestris (L) Hoffm.], and it was found that the main differences between the 8 plants were in the flowers and fruits, and that the main differences in character identification were in the characteristics of the root heads, surfaces, and cross-sections, and that the main differences in the microscopic identifications were in the types of secretory tissues and the presence or absence of posterior inclusions, etc. CONCLUSION The established taxonomic checklists can effectively identify Vicatia thibetica de Boiss and its similar species, and provide a scientific basis for its species classification and clinical use. It also lays a foundation for the exploration of the application of intelligent identification technology in the identification of Tibetan medicines, and provides information for the platform of digital specimens of traditional Chinese medicine.

OBJECTIVE To investigate accurate identification methods for the Yi medicine Cyathulae Capitatae Radix, and provide scientific basis for its accurate application. METHODS A camera imaging system was used to identify original plant differences based on plant taxonomy. A trait identification method was established through the comprehensive application of cameras,stereomicroscopes, and fluorescence microscopy imaging systems. Optical microscopy, fluorescence microscopy, and polarizing microscopy imaging systems were used to identify the differences in microscopic identification ( cross section and powder), and a thin layer identification method was established for the unique components of Cyathulae Capitatae Radix. RESULTS A key table for the origin and characteristics of the Cyathulae Capitatae Radix and its four adulterants is established, the main differences of the origin are the type and mode of inflorescence, the shape of stamens, the color of leaves, and the color and taste of the root epidermis. The differences in characters identification include color, lenticels, cross-section, texture, odor, and the location and intensity of fluorescence response under different colored light conditions. In microscopic identification, the transverse section of the root can be distinguished by the number of circles in the three vascular bundles, the number of strands in the central vascular bundle, and fluorescence reaction, but the difference in powder microscopic characteristics is not significant. The thin layer chromatography established with reference materials of saponin components such as cyaonoside A, cyaonoside B and chikusetsu saponin Ⅳa, in thin layer chromatography can effectively distinguish Cyathulae Capitatae Radix and its four adulterants, the thin layer chromatography established with the reference substance of sterol component amaranthone can effectively distinguish the other three adulterants except Cyathulae Radix. CONCLUSION Cyathulae Capitatae Radix and its four adulterants can be identified through their original plants, characteristics, microscopic cross-sections, and thin layer chromatography, and the five medicinal materials have significant differences in composition and should not be mixed.

OBJECTIVE To study and evaluate the formulation and preparation process of ozone oil inclusion compound gel. METHODS Hydroxypropyl- β-cyclodextrin (HP-β-CD) was the inclusion material and Carbome-940 was the matrix to prepare the ozone oil inclusion compound gel, and its appearance, pH value, viscosity, peroxide value, moisture retention rate, rheological properties, stability, bacteriostatic performance and biological safety were evaluated. RESULTS Finally, the semi solid gel with clear appearance, no particle feeling, uniform, fine, shiny, moderate viscosity and no greasy property was obtained. The pH value was (5.48±0.01), the viscosity was (46.78±0.18) Pa·s, and the moisture retention rates were (96.69±0.75)%, (95.84±0.44)%, and (94.12±0.89)% after 24, 36, and 48 hours of storage, respectively, with good rheological properties. The stability test showed that ozone oil gel should not be stored at high temperature. The bacteriostatic results showed that the ozone oil gel had bacteriostatic effects on Staphylococcus aureus, Candida albicans and Escherichia coli. The bacteriostatic rate of Staphylococcus aureus and Escherichia coli reached more than 95%, and the bacteriostatic rate of Candida albicans reached more than 80%. The biosafety evaluation test showed that the ozone oil gel had no vaginal mucosa irritation, skin sensitization and acute systemic toxicity. CONCLUSION The process of preparing ozone oil inclusion compound gel by this method is simple, feasible and easy to operate. It has certain promotion value and application prospect in drugs and cosmetics, which lays an experimental foundation for further industrial application of ozone oil.

OBJECTIVE To establish the first batch of national reference standard for quantitative and qualitative analysis of vortioxetine hydrobromide. METHODS The structure of vortioxetine hydrobromide was identified by means of ¹H-NMR, ¹³C-NMR, MS, IR and UV. HPLC purity was calculated via peak area normalization and principal component self-comparison. The homogeneity and stability were studied by HPLC, and other physicochemical properties were investigated using various analytical methods. The content was determined using mass balance method and verified by NMR quantitative method and differential scanning calorimetry. RESULTS The structure of the first batch of national reference substance of vortioxetine hydrobromide was confirmed and its content was determined to be 99.9%. CONCLUSION The development of the first batch of national reference substance of vortioxetine hydrobromide can meet the quality control requirements of raw material and preparations of vortioxetine hydrobromide.

OBJECTIVE To establish an experimental method using ICP-MS to study the compatibility between pantoprazole sodium for injection and neutral borosilicate glass injection bottle-coated stopper composite packaging materials. METHODS By conducting extraction experiments, simulated acceleration experiments, and migration experiments under long-term experimental conditions, the changes in elemental impurities of pantoprazole sodium for injection at different times were investigated. The simulated solution after erosion was analyzed to predict the tendency of detachment on the inner surface of boron tube bottles, and its migration amount was evaluated for safety. RESULTS The linear relationship of each element by ICP-MS method was good, and the correlation coefficient (r) was greater than 0.999 0. The quantitative limit was less than its corresponding limit of 10%. The average recovery rate was 97.5%-108.8%. In the extraction experiment, the elements with higher detected level in each sample were Si, B, and Al, but all were below the safety limits. The detected levels of other elements were relatively low, even below the detection limits. Under intermediate and long-term conditions of 6 and 12 months, the detection results of elemental impurities in various added components in the packaging materials were all lower than the AET values. CONCLUSION This method can effectively determine the content of various impurity elements in the sample and reveal their migration trends. The compatibility between the composite packaging components and pantoprazole sodium for injection is good, and the safety of the product meets the requirements. It provided a scientific basis for selecting boron tube bottle and film-covered stopper as the inner packaging material.

OBJECTIVE To evaluate and analyze real-world post-marketing adverse drug reactions(ADRs) of sindilizumab and provide critical reference for safe clinical medication. METHODS The data were sourced from the National Adverse Drug Reaction Monitoring System database, covering ADR reports related to sindilizumab in Beijing area in the past five years. These reports identified sindilizumab as the suspected drug to the ADRs. Statistical analysis was conducted using SPSS 22.0 software. RESULTS A total of 155 sindilizumab-related ADR reports were analyzed. In terms of gender distribution, the ratio of male to female patients was 1.77∶1. Skin reactions were the most common ADRs reported. Allergic reactions dominated ADR reports occurring within 24 hours. Severe ADRs accounted for 26.45% of the reports, with most severe reactions occurring after 24 hours of medication use (P=0.005). In patients with tumors not included in the approved indications, the risk of experiencing severe ADRs was significantly higher compared with those with indicated conditions (P=0.006). Nine patients experienced ADRs due to drug dosages exceeding the recommended dosage in the instructions. Additionally, the concomitant use of the drug with lenvatinib was associated with the emergence of new safety signals, including myocardial infarction and diabetic ketoacidosis, necessitating heightened vigilance in clinical practice. CONCLUSION This investigation has uncovered an augmented risk of severe ADRs in individuals receiving medications for non-indicated uses. Consequently, implementation of stricter surveillance measures is needed for patients with off-label conditions to facilitate timely medical interventions. Notably, a significant incidence of severe ADRs is observed to occur beyond the initial 24-hour period following treatment. Thus, individuals receiving the drug in day-care unit should be explicitly instructed to closely monitor their post-medication health status upon discharge and to seek immediate medical consultation in case of any arising discomfort. There exists noncompliance with the recommended dosage, thus attention should be paid to such cases. Moreover, concurrent use of sindilizumab with lenvatinib has been identified to induce myocardial infarction and diabetic ketoacidosis, representing a new safety signal that demands clinical caution.

OBJECTIVE Pregnant women are at a high risk of severe/critical SARS-CoV-2 infection, which can cause serious harm to both mothers and fetuses. Therefore, safe and effective medications are urgently needed. The current circulating strain Omicron variant JN.1 has been observed to elicit immune escape, leading to a decline in the efficacy of vaccines and neutralizing antibody drugs. As a result, the importance of small molecule antiviral drugs has become increasingly apparent, but their safety in pregnant and lactating women are not clear. METHODS Through searching domestic and international literature and databases, this paper reviews the safety data and experience of the approved small molecule anti-SARS-CoV-2 drugs (including remdesivir, molnupiravir, azvudine, renmindevir, nirmatrelvir/ritonavir, simnotrelvir/ritonavir, and leritrelvir) during pregnancy and lactation. The paper also presents information on genetic toxicity, animal and human reproductive toxicity, placental transport, and milk secretion. RESULTS Among them, the research data on remdesivir and nirmatrelvir/ritonavir are relatively sufficient. Animal studies have not found obvious reproductive toxicity, and the use of these drugs during human pregnancy has not shown serious adverse effects on mothers and fetuses. However, remdesivir is not yet listed in our country. CONCLUSION Nirmatrelvir/ritonavir may be an option for anti-SARS-CoV-2 treatment during pregnancy, and breast-feeding should be done after the drug is cleared.

OBJECTIVE To provide reference and guidance for improving the development mechanism and content of guidelines (general technical requirements) for similar content published by Chinese pharmacopoeia commission and drug regulatory agency. METHODS By reviewing the similar guidelines (general technical requirements) published by pharmacopoeia commissions and drug regulatory agencies in China, the United States, Europe, and Japan, a comparison and analysis were conducted on their similarities, differences, and mutual references in terms of their development purposes, scope of application, and specific content. RESULTS In terms of preparations, biological products, stability, impurities, dissolution, microbiological testing methods, and validation of analytical methods, pharmacopoeia commissions and drug regulatory agencies in China, the United States, Europe, and Japan have similar guidelines (general technical requirements), and there are differences in the purposes and focuses. Except for China, other countries or regions have less repetitive content and no conflicting content in the guidelines (general technical requirements) for similar content published by pharmacopoeia commissions and drug regulatory agencies. The two complement each other and jointly support the drug standard system. CONCLUSION It is recommended that China′s drug regulatory agency take the lead in determining the subjects, further optimizing and improving the harmonization mechanism, and harmonizing and unifying the guidelines (general technical requirements) developed by pharmacopoeia commission and drug regulatory agency based on the functions of each agency, to ensure that the two are clearly positioned in terms of development purposes, scope of application, and content. Strengthen the interoperability of similar content guidelines published by pharmacopoeia agency and drug regulatory agency and keep pace with international standards.

OBJECTIVE To investigate the application of the find organize clarify understand slet and information-intelligence technology to pharmacy intravenous admixture services (PIVAS) pharmaceutical service and performance evaluation. METHODS This paper used FOCUS-PDCA, the HIS, and the pre-examination prescription rational drug use software system to analyzed PIVAS data from 2020-2023. RESULTS PIVAS has greatly improved its pharmaceutical service and employee performance. It was found that the prescription review rules improved physician advice and intervention rates. The intervention ratio (intervention/audit) dropped from 14.64% to 8.64%, while the intervention success ratio rose from 48.15% to 64.50%. Before and after the library was established, the differences were statistically significant (both P<0.05); the PIVAS training and education system was optimized, and science education was regularly conducted; the drug supply process was improved to increase work efficiency; and a set of staff performance appraisal forms for static dispensing was developed, increasing staff motivation. CONCLUSION The FOCUS-PDCA cycle approach may address PIVAS pharmaceutical service problems, fully mobilize pharmacist team enthusiasm, and greatly improve PIVAS post pharmaceutical service quality, which can be promoted in PIVAS.