BACKGROUND: Benchmarking has been increasingly used on drug regulatory systems to achieve sustainable pharmaceutical system strengthening. This study aimed to identify the scope, tools and benefits of benchmarking regulatory capacities and the most recent development in such phenomenon. Method: This study employed an integrative and critical review of the literature and documents on benchmarking drug regulatory capacities identified from 6 databases and 5 websites of related organizations and government agencies in compliance with the Preferred Reporting Items for Systematic Review (PRISMA) guidelines.
RESULTS: Forty-three studies and 6 documents about regulatory benchmarking published between 2005 and 2022 were included in this review. Five benchmarking assessment tools or programmes recommended or adopted by international organizations or government agencies had been identified, which collectively covered 12 major regulatory functions (4 at system level and 8 at operational level) involving 9 indicator categories and 382 sub-indicators. Benchmarking drug regulatory systems was reportedly employed at national, regional and international levels for either internal assessment (mostly on regulatory system establishment, drug review process and post marketing surveillance) or external evaluation (mostly on regulatory standards, drug review process and pharmacovigilance systems) to assess current status, monitor performance, determine major challenges and inform actions for capacity building. Priority of actions in areas such as regulatory process, resources allocation, cooperation and communication, and stakeholder engagement have been suggested for strengthening drug regulatory systems. Nevertheless, the evidence about benchmarking in optimizing regulatory capacities remained underreported.
CONCLUSIONS: This integrative review depicted a framework for decision-makers about why and how benchmarking drug regulatory systems should be undertaken. For effective benchmarking, well-informed decisions about the goals, the scope, the choice of reference points and benchmarking tools are essential to guide the implementation strategies. Further studies about the positive effects of regulatory benchmarking are warranted to engage continuous commitment to the practice.

In the past decade, the Chinese drug regulatory system has undergone many changes. A major reform starting in 2015 has significantly reshaped the regulatory processes. It was important to assess the impact of the reform on new drug approvals in China.
We analyzed the temporal trends of regulatory characteristics of the new drugs approved by the Chinese regulatory agency from 2011 to 2021, using data collected in the Pharmcube database.
A total of 353 new drugs were approved, including 220 small molecule drugs, 86 biological products and 47 vaccines. The annual number of new drug approvals increased dramatically since 2017, reaching a record high of 70 in 2021. The median NDA approval time was 15.4 months in 2017-2021, the shortest in the decade, and was significantly shorter than that in the pre-reform period. The newly instituted expedited pathways such as priority review (PR) and accelerated approval for urgently needed overseas drugs (UNOD) significantly reduced new drug application (NDA) approval times compared with standard review. For imported drugs, in 2017-2021, the median time difference between the first approval in the world and the approval in China was 5 years, representing significant \"drug lag\". However, the proportion of the imported drugs approved in China within 3 years of its first foreign approval has increased to 24.4% in 2017-2021.
The regulatory reform has produced significant, positive immediate outcomes in several metrics of drug regulatory approval. China\'s regulatory system will continue to evolve as there still are many areas requiring further reform and improvement.

China implemented the zero-markup medicines policy to reverse the overuse of medicine in public health institutions, by changing the distorted financing mechanism, which heavily relies on revenue generated from medicines. The zero-markup medicines policy was progressively implemented in city public hospitals from 2015 to 2017.
This study is expected to generate convincing evidence with subjective measurements and contribute to a more comprehensive evaluation of the policy from both objective and subjective perspectives.
This study was based on a large patient-level dataset with a quasi-experimental design. We employed the difference-in-difference (DID) method, combined with propensity score matching methods, to estimate the causal effect of the policy in reducing overprescriptions from the patient perspective.
The study estimated a statistically significant increased probability that the responded outpatients denied overprescription in their visiting hospitals. The mean interacted policy effect, in percentage points, of all observations were positive (logit DID model: 0.15, z = 10.27, SE = 0.01; PSM logit DID model: 0.15, z = 10.26, SE = 0.01; PSM logit DID hospital fixed-effect model: 0.12, z = 3.00, SE = 0.04).
The policy might reduce overprescription in public hospitals from the patient\'s perspective. The patient\'s attitude is one aspect of a comprehensive policy evaluation. The final concrete conclusion of the policy evaluation can only be made through a systematic review of the studies with rigorous design and with both objective and subjective measurements.

UNASSIGNED: To describe and assess the hospital drug control system\'s measures.
UNASSIGNED: From 2017 to 2019, examine the changes in medication percentage, important monitoring drug amount, top 10 medications amount, and usage rate of prophylactic antibiotics for type I incisions.
UNASSIGNED: The proportion of pharmaceuticals remains below 30%, the number of significant monitoring drugs has decreased, the top ten drugs have shifted from adjuvant to therapeutic drugs, and the use of prophylactic antibiotics for type I incisions has decreased by 10%.
UNASSIGNED: The percentage of medications that met requirements by using the drug control system has steadily decreased, and the number of pharmaceuticals for important monitoring pharmaceuticals has steadily decreased, in accordance with national medical insurance policy, as well as improved rational drug usage.

In China, although drug use is an administrative and not criminal offense, individuals detained by public security authorities are subject to coercive or compulsory \"treatment,\" which can include community-based detoxification and rehabilitation and two years of compulsory isolation. Individuals are also entered into a system called the Drug User Internet Dynamic Control and Early Warning System, or simply the Dynamic Control System. The Dynamic Control System, run by the Ministry of Public Security, acts as an extension of China\'s drug control efforts by monitoring the movement of people in the system and alerting police when individuals, for example, use their identity documents when registering at a hotel, conducting business at a government office or bank, registering a mobile phone, applying for tertiary education, or traveling. This alert typically results in an interrogation and a drug test by police. This paper seeks to summarize, using published government reports, news articles, and academic papers, what is known about the Dynamic Control System, focusing on the procedures of (1) registration; (2) management; and (3) exit. At each step, people subject to the Dynamic Control System face human rights concerns, especially related to the right to privacy, rights to education and work, and right to health.

Liposomes have been considered promising and versatile drug vesicles. Compared with traditional drug delivery systems, liposomes exhibit better properties, including site-targeting, sustained or controlled release, protection of drugs from degradation and clearance, superior therapeutic effects, and lower toxic side effects. Given these merits, several liposomal drug products have been successfully approved and used in clinics over the last couple of decades. In this review, the liposomal drug products approved by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) are discussed. Based on the published approval package in the FDA and European public assessment report (EPAR) in EMA, the critical chemistry information and mature pharmaceutical technologies applied in the marketed liposomal products, including the lipid excipient, manufacturing methods, nanosizing technique, drug loading methods, as well as critical quality attributions (CQAs) of products, are introduced. Additionally, the current regulatory guidance and future perspectives related to liposomal products are summarized. This knowledge can be used for research and development of the liposomal drug candidates under various pipelines, including the laboratory bench, pilot plant, and commercial manufacturing.

Drug-related adverse reactions are among the main reasons for harm to patients under care worldwide and even their deaths. The pharmacovigilance system has been proven to be an effective method of avoiding or alleviating such adverse events. In 2019, after two decades of implementation of the drug-related adverse reaction reporting system, China formally implemented a pharmacovigilance system with the Pharmacovigilance Quality Management Standards and a series of supporting technical documents created to improve the safety of medication given to patients. China\'s pharmacovigilance system has faced many problems and challenges during its implementation. This spontaneous reporting system is the main source of data for China\'s medication vigilance activities, but it has not provided sufficiently powerful evidence for regulatory decision-making. In conformity with the health-centred drug regulatory concept, the Chinese government has accelerated the speed of examination and approval of urgently needed clinical drugs and orphan drugs along with the requirement to improve the safety supervision of these drugs after their listing. China\'s marketing authorization holders (MAHs) must strengthen their pharmacovigilance capabilities as the primary responsible departments for drug safety. Chinese medical schools generally lack professional courses on pharmacovigilance. The regulatory authorities have recognized such problems and have made efforts to improve the professional capacity of pharmacovigilance personnel and to strengthen cooperation with stakeholders through the implementation of an action plan of medication surveillance and the establishment of a patient-based adverse events reporting system and active surveillance systems, which will help China bridge the gap to bring its pharmacovigilance practice up to standards.

Rapid, precise, and tunable regulation of protein abundance would be significantly useful in a variety of biotechnologies and biomedical applications. Here, we describe a system that allows tunable and rapid drug control of gene expression for either gene activation or inactivation in mammalian cells. We construct the system by coupling Tet-on 3G and small molecule-assisted shutoff systems, which can respectively induce transcriptional activation and protein degradation in the presence of corresponding small molecules. This dual-input drug inducer regulation system facilitates a bidirectional control of gene expression. The gene of interest can be precisely controlled by dual small molecules in a broad dynamic range of expression from overexpression to complete silence, allowing gene function study in a comprehensive expression profile. Our results reveal that the bidirectional control system enables sensitive dosage- and time-dependent regulation for either turn-on or shutoff of gene expression. We also apply this system for inducible genome editing and gene activation mediated by clustered regularly interspaced short palindromic repeats. The system provides an integrated platform for studying multiple biological processes by manipulating gene expression in a more flexible way.

Arsenosugars are a group of arsenic-containing ribosides that are found predominantly in marine algae but also in terrestrial organisms. It has been proposed that arsenosugar biosynthesis involves a key intermediate 5\'-deoxy-5\'-dimethylarsinoyl-adenosine (DDMAA), but how DDMAA is produced remains elusive. Now, we report characterization of ArsS as a DDMAA synthase, which catalyzes a radical S-adenosylmethionine (SAM)-mediated alkylation (adenosylation) of dimethylarsenite (DMAsIII ) to produce DDMAA. This radical-mediated reaction is redox neutral, and multiple turnover can be achieved without external reductant. Phylogenomic and biochemical analyses revealed that DDMAA synthases are widespread in distinct bacterial phyla with similar catalytic efficiencies; these enzymes likely originated from cyanobacteria. This study reveals a key step in arsenosugar biosynthesis and also a new paradigm in radical SAM chemistry, highlighting the catalytic diversity of this superfamily of enzymes.

The study investigates the prevalence of drugs of abuse detected from 2016 to 2018 through i) forensic drug testing of seizures from law enforcement agencies, and ii) common drugs of abuse for urinalysis of samples obtained from offenders/probationers under mandatory drug-use surveillance programmes. Under the selected drug testing groups, an average of 4677 cases/year (c.f. 5334 cases/year in 2011-2015) of illicit drug seizures and 19,501 samples/year (c.f. 28,438 samples/year in 2011-2015) for urinalysis, were examined from 2016 to 2018. The three most commonly encountered abused drugs in the period in both types of examinations were methamphetamine (MA), cocaine and heroin. The occurrence of ketamine, the most prevalent drug [1815 (34.0%) cases/year (for drug seizures), 2074 (7.3%) samples/year (for urinalysis)] in 2011-2015, had dropped significantly to 487 (10.4%) cases/year and 350 (1.8%) samples/year respectively. The drug positive rates for urinalysis in the selected population group (i.e., offenders/probationers requiring mandatory drug testing) increased steadily from 27.3% in 2016 to 30.8% in 2018 (an average of 29.0% vs. 22.1% in 2011-2015). The ratio of single drug use to more than one drug was about 4:1, showing predominant use of single drug. While MA was the most prevalent drug in the period, cases found with cocaine and cannabis increased steadily over the past 3 years. A rising trend was noted for cases identified with new psychoactive substances (NPS) in illicit drug seizures from an average of 87 cases/year in 2011-2015 to 211 cases/year in 2016-2018 although NPS cases still contributed to less than 5% of overall drug seizures. A total of 69 substances classified as NPS were encountered with 47 NPS newly encountered in 2016-2018 but 25 NPS found in 2011-2015 disappeared in this 3-year period. Cathinones, including both synthetic and plant-based, continued to be the major category of NPS cases (∼72%) in the region followed by synthetic cannabinoids, ketamine/PCP analogs and synthetic opioids.