Considerations on the chemistry, manufacture and control requirements for conditional marketing authorization drugs in China / 中国药科大学学报

@#Drug Administration Law revised in 2019 proposed for the first time conditional marketing authorization at the legal level, marking the formal implementation of the conditional marketing authorization in China. This paper compares the regulations and technical requirements of conditional marketing authorization drugs in China with those in Europe and the United States, in an attempt to learn from the experience of chemistry, manufacture and control review of these drugs in Europe and the United States, and to discuss the pharmaceutical technical requirements of conditional marketing authorization drugs in China.

Enlightenment on Carrying out Reporting Responsibility of Manufactures in China from Reviewing Medical Device Reporting Practice in US / 中国医疗器械杂志

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.

A cross-sectional study of factors related to traditional Chinese medicine use for hospitalized acute coronary syndrome patients in China's level 2 hospitals / 中华心血管病杂志

<p><b>OBJECTIVE</b>To explore the current status on traditional Chinese medicine (TCM) use for hospitalized acute coronary syndrome patients in China's level 2 hospitals, and to explore associated factors of TCM use for these patients.</p><p><b>METHODS</b>This survey was performed in 102 level 2 hospitals from 15 provinces or autonomous region in China. Patients admitted to these hospitals with acute coronary syndrome during September 2011 to May 2012 were eligible for this study. Information on TCM use was obtained from their medical records. Chi-square test and logistic regression analysis were used to explore the related factors of TCM use in these patients.</p><p><b>RESULTS</b>We recruited 5 432 acute coronary syndrome patients in this study, TCM was applied to 3 503 patients (64.5%). Multivariable logistic regression showed that pre-hospital TCM use was positively related with in-hospital TCM use (OR = 2.08, P < 0.01) , while pre-hospital use of 4 medicines recommended by the guidelines(including aspirin/clopidogrel, β acceptor blocker, stain and angiotensin converting enzyme inhibitor/angiotensin converting enzyme receptor blocker ), being a smoker and diagnosis of myocardial infarction rather than unstable angina at hospital discharge were negatively related with in-hospital TCM use (the ORs were 0.58, 0.78 and 0.71, respectively, all P < 0.01). The TCM use varied significantly between regions. Taking southwest region as a reference, the ORs varied between 2.98-13.37 (all P < 0.01) in eastern China, south China, central China, north China, northwest and northeast regions.</p><p><b>CONCLUSIONS</b>TCM is widely used in hospitalized acute coronary syndrome patients in China's resource-constrained level 2 hospitals. Pre-hospital TCM use is positively correlated with in-hospital TCM use for these patients.</p>