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Copyright of Evaluation & Analysis of Drug-Use in Hospitals of China is the property of Evaluation & Analysis of Drug-Use in Hospitals of China Editorial Board and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Up till now, China has not enacted any legal mechanisms governing certification or supervision for ethics committees. This article analyses deficiencies in the protection of subjects in clinical drug trials under China’s current laws and regulations; it emphasizes that investigators, as practitioners who have direct contact with subjects, play significant roles in protecting and safeguarding subjects’ rights and interests. The paper compares the status quo in China in this area to that of other countries and discusses ways China might enhance the protection of rights and interests of trial subjects, such as enhancing the ethical awareness of investigators through training, improving laws and regulations, and strengthening the communication between investigators and ethics committees. [ABSTRACT FROM AUTHOR]

Abstract: In the wake of the deteriorating situation of drug addiction and related infectious diseases among injecting drug users (IDUs) in China in recent years, the Standing Committee of the National People''s Congress of China adopted the new Drug Control Law which came into force in June 1, 2008. This law is part of a broad reform movement in China where drug addiction is no longer understood as simply a legal or moral issue but rather, as a complicated medical condition requiring comprehensive therapeutic strategies. Although the Drug Control Law draws a distinct line from previous Drug Control regulations in the country, there have still been dilemmas along the implementation process. This paper is intended to elaborate on the general principles of China''s latest Drug Control Law from the point of view of scholars who are involved in the field of drug addiction research and treatment in China. This paper will also discuss the challenges we are currently facing, based on the observations and practical experiences the authors have obtained in China. It is hoped that by addressing these issues, we will be able to implement the new Drug Control Law more successfully and ensure that we deal more effectively with drug addiction in China. [Copyright &y& Elsevier]

It has been 3 years since China implemented new management regulations for drug clinical trial institutions in December 2019, the most important of which is to change the qualification recognition of drug clinical trial institutions into recordkeeping system. The original intention of the institution record-keeping system was to solve the shortage of clinical trial resources in China, effectively expand the number of clinical trial institutions, and effectively alleviate the contradiction between medical treatment and scientific research. After implementing the record-keeping system, although these goals have been achieved to a certain extent, there are still areas worthy of optimization and improvement. Therefore, we evaluated the new process, in particular the requirements, in order to see what possible barriers in the record-keeping system of institutions. We find that the requirements for principal investigator (PI) qualifications are the key to the recordkeeping system. This reflects the shift of Chinese regulators' supervision of clinical trials to supervision of the ability to conduct clinical trials. However, the ambiguity of the definition of PI qualification has hindered implementation of the recordkeeping system and reduced the release of clinical trial resources. [ABSTRACT FROM AUTHOR]

Background: Clinical researches of stem cell‐based therapies are highly active in China, while it was arduous to determine the most effective way of clinical translation of those advanced therapies. Methods: This article briefly introduced the regulatory framework development, the progress in stem cell clinical researches and clinical trials of commercially developed stem cell‐based products, as well as the clinical review concerns of stem cell‐based products in China. Main findings: The current regulatory framework of stem cell clinical researches in China was launched in 2015, when regulatory authorities issued "Administrative Measures on Stem Cell Clinical Research" (AMSCCR) detailing the rules of stem cell clinical research. Thereafter, the rapidly growing stem cell clinical researches were rigorously managed and clinical use of stem cell therapy was halted. Meanwhile, commercially developed stem cell‐based products are supervised by Drug Administration Law (DAL). Conclusion: The regulatory framework of stem cell‐based therapy in China has progressed in the last few decades, which is currently regulated according to AMSCCR and DAL. Well‐designed and patient‐focused clinical trial is required for commercially developed stem cell‐based products, and definite clinical benefit evidence is crucial to obtain marketing authorization. [ABSTRACT FROM AUTHOR]

Background: The National Medical Products Administration (NMPA) in China has set to advance the regulatory capacity of traditional Chinese medicines (TCMs) with the adoption of regulatory science (RS). However, the priority of actions at the interface of RS and TCMs were yet to be defined. This research aims to identify the priority areas and summarize core actions for advancing RS for traditional medicines in China. Methods: A mixed approach of documentary analysis of government policies, regulations and official information about TCMs regulation in China, and a scoping review of literature using 4 databases (PubMed, ScienceDirect, Scopus and CNKI) on major concerns in TCMs regulation was employed. Results: Ten priority areas in the development of TCM-related regulatory science in China have been identified, including: (1) modernizing the regulatory system with a holistic approach; (2) advancing the methodology for the quality control of TCMs; (3) fostering the control mechanism of TCMs manufacturing process; (4) improving clinical evaluation of TCMs and leveraging real world data; (5) re-evaluation of TCMs injection; (6) developing evaluation standards for classic TCMs formula; (7) harnessing diverse data to improve pharmacovigilance of TCMs; (8) evaluating the value of integrative medicine in clinical practice with scientific research; (9) advancing the regulatory capacity to encourage innovation in TCMs; and (10) advancing a vision of collaboration for RS development in TCMs. Conclusions: RS for TCMs in China encompasses revolution of operational procedures, advancement in science and technology, and cross-disciplinary collaborations. Such experiences could be integrated in the communications among drug regulatory authorities to promote standardized and scientific regulation of traditional medicines. [ABSTRACT FROM AUTHOR]

Copyright of Journal of Chinese Pharmaceutical Sciences is the property of Journal of Chinese Pharmaceutical Sciences and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

The illicit supply of new psychoactive substances (NPS) in and from China has become a global concern. In line with the international prohibitionist regime, China has instituted a "zero tolerance" supply reduction policy, enacted various laws to regulate controlled substances, and punished related criminal behaviors severely. However, how the NPS supply is organized and how the national laws are interpreted and implemented at the local level have rarely been addressed. Data from qualitative interviews with governmental and judicial actors are used to investigate the experiences concerning the illicit supply of methcathinone and the dynamic ways in which drug policy and laws are implemented practically. Findings show the significance of Changzhi city as a distribution center for illicit supply of methcathinone, the fixed supply patterns, the prioritized measures for controlling methcathinone supply and demand, and the personal strategies used by individual actors to cope with political pressures and job requirements. This study concludes that the unbalanced coexistence of campaign-style and conventional governance results in active institutional arrangements and passive personal strategies in implementing the drug policy and further contributes to a discrepancy between policy formulation and its implementation in practice. [ABSTRACT FROM AUTHOR]

Background Rational drug use and drug safety are becoming increasingly important concerns in China with the increasing public access to drugs and the health-care system, and this has led to the development of pharmacovigilance in China. Aim of the review To provide a brief introduction about pharmacovigilance in China in terms of system development, utilization and challenges. Method Relevant studies on pharmacovigilance related to the study aim was undertaken through literature search to synthesize the extracted data. Results The creation and evolvement of China's pharmacovigilance system spans across 30 years since 1989. The system consists of four progressing administrative layers: county, municipal, provincial and national levels. China has passed over 20 laws and regulations related to pharmacovigilance covering the processes of drug development, manufacture, distribution and use with the aim to guard drug safety. An online spontaneous self-reporting Adverse Drug Reaction (ADR) Monitoring System was established in 2003. ADRs are mainly reported by medical institutions, pharmaceutical manufacturers, and drug distributors. Currently there is no mandatory ADR reporting requirement for pharmaceutical manufacturers, and a proposed regulation under public comment will likely change this. China has started to build active pharmacovigilance surveillance programs in addition to the passive ADR reporting system. The China Food and Drug Administration has established the intensive Safety Monitoring Program and the National Adverse Drug Reaction Monitoring Sentinel Alliance Program based on electronic health records to further the efforts of ADR reporting, monitoring and analysis. Conclusion The practice of ADR monitoring and pharmacovigilance in China have made great progress. More efforts are needed both in system building, and creation of laws and regulations to strengthen the safe use of medicines. [ABSTRACT FROM AUTHOR]

The regulation of new psychoactive substances (NPS) has confounded governments throughout the western world. In 2014 the UK government convened an NPS Review Expert Panel to consider a range of approaches. Ultimately the Panel recommended that the government ban all new psychoactive drugs and allow only psychoactive substances specifically exempted, such as alcohol, tobacco and those allowed as medicines. The government introduced the Psychoactive Substances Bill (PSB) in response to that recommendation. Passed in 2016, the Bill has attracted a torrent of criticism from scientists and experts. The Bill could be improved with revision, but the problems of the total ban, as envisioned by the PSB, with respect to the NPS, may be inherent: (1) defining psychoactivity is conceptually fraught, with great consequence for the scope of the prohibition; (2) operationalizing psychoactivity as a usable concept for legal control purposes is extremely difficult, perhaps impossible; and (3) the detachment of penalties for violating a total ban from establishing the harmfulness of a substance is normatively troubling. Given the uncertainties about the effects of a total ban, it is appropriate at this time for other governments to assess more fully the nature of the NPS problem, and the potential control approaches. [ABSTRACT FROM AUTHOR]

The article reflects on the implications of the death sentence handed out to Zheng Xiaoyu, former head of China's State Food and Drug Administration on the country's effort to build a fair drug regulation regime. He relates that Zheng's death sentence do not prove anything on the country's sincerity in building an effective regulatory process. Rather, he stresses that it only confirms the worst fears of the pharmaceutical industry that fair business is less likely to happen in China

Calling into question different motives to transport drugs, the typical divisions of labor in Chinese drug circuits, and the sentences meted out to smugglers, Chen Xingliang examines the rationale of punishment schedules under the Criminal Law of China. Chen takes the position that when sufficient evidence is presented to prove a person was employed by others to transport drugs, the death penalty should not apply. [ABSTRACT FROM AUTHOR]

Presents a study that discussed the regulations in the revised Pharmaceutical Administration Law in China that came into effect in December 2001. Background on the State Drug Administration of China; Details on several pharmaceutical regulations; Challenges faced by the pharmaceutical sector in China.