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Zhang L.,Center for Drug Reevaluation | Wong L.Y.L.,University of Hong Kong | He Y.,University of Hong Kong | Wong I.C.K.,University of Hong Kong
Drug Safety | Year: 2014

With the integration of the global pharmaceutical economy and the gradual transformation of the healthcare insurance system in China, the legislative framework for a comprehensive regulatory system monitoring the whole process including drug development, manufacture, distribution and use has been established by the China Food and Drug Administration (CFDA) to ensure the safety and effectiveness of medication use. China has established a relatively comprehensive pharmacovigilance system covering regulation, organisation and technology from 1989 to 2014. As of 2013, one national centre, 34 provincial centres and more than 400 municipal centres for adverse drug reaction (ADR) monitoring were included in the four-level pharmacovigilance network (national, provincial, municipal and county) with more than 200,000 grassroot organisation users. The China Adverse Drug Reaction Monitoring System (CADRMS) is an online spontaneous reporting system which connects the four-level pharmacovigilance network. By 2013, CADRMS had received over 6.6 million ADR case reports. After integrating and analysing pharmacovigilance data, the National Centre for ADR Monitoring (NCADRM) publishes medication safety information by releasing ADR bulletins, National ADR Annual Reports and International Pharmacovigilance Newsletters. The NCADRM also routinely provides CADRMS data feedback to manufacturers. The CFDA implemented risk management through several approaches, including arranging ‘manufacturer communication meetings’, modification of medication package inserts, and restriction, suspension or withdrawal of marketing authorisations. Seamless information exchange with overseas regulatory authorities and organisations remains an area for improvement. Further development of the China pharmacovigilance system in terms of signal generation, post-marketing pharmacoepidemiology research and education is also needed. © 2014, Springer International Publishing Switzerland. Source

Zhao J.,Chinese Academy of Sciences | Yang M.,Jiangxi University of Traditional Chinese Medicine | Chen Y.,Center for Drug Reevaluation | Ye Z.,Chinese Academy of Sciences
Zhongguo Zhongyao Zazhi | Year: 2010

The basic situation of formation and development of toxicity theory of traditional Chinese medicine in China was systematically summarized in this paper. A new "Network regulation theory" hypothesis about of toxicity of traditional Chinese medicine was firstly proposed and provided scientific bases for the clinic application of toxic traditional Chinese medicine. Source

Xia D.-S.,Center for Drug Reevaluation
Chinese Traditional and Herbal Drugs | Year: 2011

The toxicity of Chinese materia medica (CMM) is one of cores of the property theory of CMM. From the perspective of history, the literature source of the understanding on CMM toxicity was traced; The traditional and contemporary understanding about the meaning and classification of CMM toxicity was compared and analyzed; The ideas on CMM toxicity with the feature of tradition, experience, objectivity, the integrity of the concept, and some of the controllability were proposed; The theory and practice of traditional Chinese medicines should be combined in order to effectively integrate and apply various modern scientific and technical methods, and create new ideas about toxicity studies of CMM, which has the important significance on the comprehensive understanding about CMM toxicity, strengthening the research on CMM toxicity, and promoting the safety of CMM in clinical use. Source

Ren Y.,Chinese Institute of Materia Medica | Ren Y.,Chengdu University of Traditional Chinese Medicine | Zhang P.,Chinese Institute of Materia Medica | Yan D.,Chinese Institute of Materia Medica | And 3 more authors.
Journal of Pharmaceutical and Biomedical Analysis | Year: 2011

Herbal injections are powerful preparations of traditional Chinese medicines. However, the quality control (QC) of these formulations is difficult to establish. Recently, chemical fingerprinting (CF) has been recommended as a potential strategy for the QC of herbal injections. However, some constituents cannot be detected by chromatographic methods. To establish a comprehensive QC process, biological fingerprinting (BF) was combined with CF to detect the fluctuation in quality of a herbal injection from chemical and biological aspects. Yinzhihuang injection was selected as a representative herbal injection. Ten batches of normal samples and six batches of artificially abnormal samples were collected. High-performance liquid chromatography and thermal activity monitoring were applied to develop CF and BF, respectively. The CF and BF of normal samples were similar, with good stability and consistency, but the abnormal samples were not. The results were analyzed by hierarchical clustering analysis: all abnormal samples could be correctly distinguished when CF and BF were combined. The recognition ratio was higher for CF (87.5%) than for BF (93.75%). The key factors of quality fluctuation were bacterial contamination, high temperature, lighting, and sterilizing conditions. The described method could be used for early prediction of adverse drug events, which could help improve the safety of herbal injections. © 2011 Elsevier B.V. Source

Lei X.,Tianjin University of Traditional Chinese Medicine | Chen J.,Tianjin University of Traditional Chinese Medicine | Ren J.,Center for Drug Reevaluation | Li Y.,Tianjin University of Traditional Chinese Medicine | And 7 more authors.
Evidence-based Complementary and Alternative Medicine | Year: 2015

Objective. To summarize the characteristics and analysis of relevant factors and to give references for prevention and further study of liver damage associated with Polygonum multiflorum Thunb. (HSW), we provide a systematic review of case reports and case series about liver damage associated with HSW. Methods. An extensive search of 6 medical databases was performed up to June 2014. Case reports and case series involving liver damage associated with HSW were included. Results. This review covers a total of 450 cases in 76 articles. HSW types included raw and processed HSW decoction pieces and many Chinese patent medicines that contain HSW. Symptoms of liver damage occur mostly a month or so after taking the medicine, mainly including jaundice, fatigue, anorexia, and yellow or tawny urine. Of the 450 patients, two cases who received liver transplantation and seven who died, the remaining 441 cases recovered or had liver function improvement after discontinuing HSW products and conservative care. Conclusion. HSW causes liver toxicity and may cause liver damage in different degrees and even lead to death; most of them are much related to long-term and overdose of drugs. Liver damage associated with HSW is reversible, and, after active treatment, the majority can be cured. People should be alert to liver damage when taking HSW preparations. © 2015 Xiang Lei et al. Source

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