从质量标准的角度探析中国药品安全问题.pdfVIP

2010 6 27 3 Chinese Jo rnal of Social Medicine, J ne 2010, Vol. 27, No. 3 ! 129 ! ! ! 杨廉平, 姚强, 张新平 , , , , ; ; , , , ; R951 A DOI:103969/ jissn16735625201003001 Analysis of the Drug Safety from the erspective of Quality Standard YANG Lianping, YAO Qiang, ZH ANG Xinping School of M ed icine and H ealth M anag ement , T ongj i M ed ical Colleg e, H uaz hong Un iv er sity of S cience and Technology , W uhan, 430030, China Abstract Objectives T o st dy the dr g safet y from the perspect ive of q ality st andard Methods Searching and collect ing pertinent literat re and paper relating to dr g q ality standard, and then s mmarizing and analyzing them Results The c rrent sit at ion of the national q ality standard is worrying that dr g q ality standards in China are vario s widely, t he test content s of the same dr g standard is not nif ied, and the c rrent q ality standard can∀ t con t rol the process of dr g prod ct ion T hro gh the comparison of management of dr g q alit y standard w ith developed co ntries, there are many difference betw een Chinese pharmacopoeia and American pharmacopoeia in legal stat s, standardsett ing methods and standard contents Conclusions China needs to finish the c rrent vario s standards rgently, est ablish and improve t he scientific mechanism of dr g q alit y standards grad ally , foster and develop inter mediary organizations and enhance timeliness and operability of standard, and then improve and ens re the dr g q ali t y standards and dr g safety Key words Dr g q ality standard; Dr g safet y 2009 # ∃ , ; ISI Web of Science :% , , , , %