As information on safety and effectiveness is not comprehensive, gained from the researches for listing approval of Chinese medicine, it is very necessary to conduct post-marketing clinical re-evaluation of Chinese medicine. Effectiveness, safety and economic evaluation are three main aspects of post-marketing clinical re-evaluation. In this paper, the difference and relations between the post-marketing clinical re-evaluation and the phase IV clinical trials were discussed, and the basic requests and suggestions were proposed, according to the domestic and foreign relevant regulations and experts' suggestions, and discussed the requirements of the phase IV clinical trials on indications, design methods, inclusion and exclusion criteria, sample size, etc.
Clinical Trials, Phase IV as Topic ; Humans ; Medicine, Chinese Traditional ; adverse effects ; Product Surveillance, Postmarketing ; Research Design

Due to the limitations of pre-authorization clinical trials, the safety information obtained from them is relatively limited. Therefore, it is very necessary to carry out pharmacovigilance activities on drugs post-marketing. In order to promote the specific implementation of the new pharmacovigilance regulations, the European medicines agency (EMA) developed the Guideline on Good Pharmacovigilance Practices (GVP), as the new criteria for pharmacovigilance in the European Union (EU). Compared with the previously published, Guidelines on Pharmacovigilance for Medicinal Products for Human Use (2007), the GVP proposed more comprehensive and systematic provisions of pharmacovigilance systems, quality control systems, judgements, pharmacovigilance inspections and audits. In addition, it set more specific and comprehensive requirements on risk management systems, the management and reporting of adverse reactions to medicinal products, periodic safety update reports, post-authorization safety studies, signal management, and so on. Interpreting the basic principles, working mechanisms, key technologies and methods of the GVP provides a useful reference for us to carry out pharmacovigilance (especially regarding safety monitoring of parenterally administered Chinese medicine).
Books ; European Union ; organization & administration ; Humans ; Pharmacovigilance ; Product Surveillance, Postmarketing ; standards ; Translating

With the continuous improvement of international "pharmacovigilance" technology and methods,it becomes the key part of the post-marketing evaluation. This issue is based on this research background, and also means to find out the Chinese medicine safety monitor which consistents with the reality. A common problem is that those who choose a career in pharmacovigilance know how the complex data presented to us are a source of both fascination and frustration. In the 70's, for the first time data mining technology in the international pharmacovigilance turn up, we try to establish new signal detection method to make contributes to post-marketing evaluation of Chinese medicine and establishment of registration. Building the national adverse reaction reporting database is widely used in western country. Nature of the problem is that pharmacovigilance issues can come through a lot of assumptions into the statistical problems, different assumptions are for different statistical tests. Through the traditional imbalance between the proportion of fourfold table for other assumptions, few countries use in practice, this does not involve evidence, but this issue provides the introduce of the principle. Methods include the ratio of the report of the Netherlands (ROR), the proportion of reports than the UK ratio (PRR),WHO's information points (IC), the U.S. Food and Drug Administration empirical Bayes (EBS), etc. Because there is no international gold standard of the signal detection method, at first we use the simulation comparing these four methods of data mining, From the point of specificity, the sample size demand, this issue views the advantages and disadvantages of four methods and application conditions,and from a technical point of view and try to propose a new signal detection method, for example, Hierarchical Bayesian.
Data Mining ; Humans ; Medicine, Chinese Traditional ; adverse effects ; Pharmacovigilance ; Product Surveillance, Postmarketing

In 2013,China pharmaceutical regulatory department issued guiduance on postmarketing drug safety monitoring for industry. It aimed to encourage industry to carry out postmarketing drug safety monitoring including hospital-based intensive monitoring of postmarketing Chinese patent medicine. Subsequently,more and more such kind of studies have been performed all over China. However,in view of the current situation in this field,the development of hospital-based intensive monitoring of postmarketing Chinese patent medicine lacks standardization,such as unreasonable design,omission of reports about adverse drug reactions,inadequate process of quality control,non-standardized interpretation of adverse reactions,etc. Therefore,it is necessary to formulate relevant technical specifications to guide this area. The developing of this technical specification refered to the international post-marketing safety monitoring model and advanced design concepts and methods. We developed it under the guidance of relevant laws,regulations and technical documents in China. Meanwhile the characteristics of Chinese patent medicines and the real situation in this area were considered. The aim of this technical specification is to obtain the incidence,type,degree and clinical manifestation of adverse drug reactions of Chinese patent medicines,to find new risk signals of adverse reactions,to identify risk factors,and to provide a basis for the formulation of risk management and control plans. This specification has been approved by China association of Chinese medicine which is numbered T/CACM011-2016.
Adverse Drug Reaction Reporting Systems ; China ; Hospitals ; Medicine, Chinese Traditional ; Nonprescription Drugs ; Product Surveillance, Postmarketing

AIM: Combine disproportionality analysis with dynamically interactive graphics to understand spontaneously-reported adverse events in pharmacovigilance. METHODS: Four statistical methods, including Reporting Odds Ratio, Proportional Reporting Ratio, Multi-Item Gamma Poisson Shrinker and Bayesian Confidence Propagation Neural Network that are used for computing disproportionality are described. Tree maps and other graphical techniques are used to display the disproportionality results. RESULTS: Spontaneously-reported adverse events in pharmacovigilance are collected from physicians, patients, or the medical literature by regulatory agencies, pharmaceutical companies and device manufacturers to monitor the safety of a product once it reaches the market. In order to identify potential safety-signals, disproportionality analysis methods compare the rate at which a particular event of interest co-occurs with a given drug with the rate this event occurs without the drug in the event database. Tree maps are employed to interactively display the adverse events for particular drugs and compare the adverse events among the drugs. CONCLUSION Interactive graphical displays of disproportionality allow the analyst to quickly identify safety signals and perform additional follow-up analyses. Combining statistical methods with dynamically interactive graphics affords insights into the data inaccessible by traditional analysis methods.
Adverse Drug Reaction Reporting Systems ; statistics & numerical data ; Bayes Theorem ; Data Interpretation, Statistical ; Databases, Factual ; Drug-Related Side Effects and Adverse Reactions ; Humans ; Odds Ratio ; Pharmacovigilance ; Product Surveillance, Postmarketing ; statistics & numerical data

Regarding the information collected, analysis and actions that have been taken, the issues in the process of the Post-market Surveillance for Medical Device were analyzed, and some suggestions were given at the same time.
Equipment Safety ; Equipment and Supplies ; Product Surveillance, Postmarketing

By analysis on the risk management regulations and the situation of medical device after the product on the market, information list of problems and risk analysis process of the production and after-production were described, simultaneously, the suggestions were put forward to risk management after the product on the market, with the aim of providing reference for manufacturers and administrators.
Equipment Safety ; Product Surveillance, Postmarketing ; Risk Management

European Union (EU) medical device supervision system is more complete, has a lot of experiences and characteristics worth learning. This paper introduces a brief overview of the process of medical devices market in the EU, including three core medical device directives, process of obtaining CE mark, medical devices vigilance system and supervision after obtaining the CE mark, etc. Simultaneously, preliminary enlightenments of the EU medical devices supervision to our national medical devices' technical review process are discussed with the aim of providing reference for supervision, technical review unit and manufacturer.
Device Approval ; European Union ; Product Surveillance, Postmarketing

OBJECTIVE: By introducing the Medical Device Reporting (MDR) system and related inspection practice of the US, this paper puts forward some suggestions on implementing reporting responsibility of manufactures in China. METHODS: The MDR system and the related inspection system in the US were systematically analyzed. RESULTS: The US had established a sound system for discovering and reporting MDR, and a mechanism for inspecting the implementing of manufactures, forming an effective post-market surveillance system. CONCLUSIONS By learning from the experience of the US, we can carry out the post-market surveillance of medical devices adverse events in China from the aspects of implementing the existing system, strengthening the reporting ability and perfecting the inspection mechanism.
China ; Equipment and Supplies/standards* ; Product Surveillance, Postmarketing

This article analyzes common problems and offers some suggestions on full life-cycle supervision and administration process of diagnostics, including premarket technical evaluations, pre-market QMS on-site inspections, postmarket adverse event surveillance, unannounced inspections and re-evaluation, from regulators' perspectives. It aims to provide technical reference for revisions on regulations, and help government administrators to figure out major points in daily regulatory practice.
Diagnosis ; Equipment and Supplies ; Product Surveillance, Postmarketing