{"id":1586,"date":"2015-10-21T19:53:32","date_gmt":"2015-10-21T19:53:32","guid":{"rendered":"http:\/\/www.wi.rwth-aachen.de\/SmartMedCN\/?p=1586"},"modified":"2015-10-21T19:53:32","modified_gmt":"2015-10-21T19:53:32","slug":"three-ministries-and-commissions-require-drugs-clinical-trial-institutions-to-carry-out-a-self-inspection","status":"publish","type":"post","link":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/2015\/10\/21\/three-ministries-and-commissions-require-drugs-clinical-trial-institutions-to-carry-out-a-self-inspection\/","title":{"rendered":"Three ministries and commissions require drugs clinical trial institutions to carry out a self-inspection"},"content":{"rendered":"<p style=\"text-align: justify\"><strong>Recently, China Food and Drug Administration (CFDA) published an announcement about carrying out a self-inspection of drugs clinical trial data. There will be an inspection of clinical trial data, especially for drugs which are already declared for production and imported drugs which are going to be examined. To complete the work of inspection, drugs clinical trial institutions are required to carry out a self-inspection and be prepared to cooperate for the scene inspection. Irregularity actions which are found during the scene inspection will be dealt seriously. 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justify\">[\/hide]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Recently, China Food and Drug Administration (CFDA) published an announcement about carrying out a self-inspection of drugs clinical trial data. There will be an inspection of clinical trial data, especially [&hellip;]<\/p>\n","protected":false},"author":1001,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"c2c_always_allow_admin_comments":false,"footnotes":""},"categories":[5],"tags":[10,13,17],"class_list":["post-1586","post","type-post","status-publish","format-standard","hentry","category-pharmaceutical-company-news","tag-dispute","tag-drug-saftey","tag-government-supervision"],"_links":{"self":[{"href":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/wp-json\/wp\/v2\/posts\/1586","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/wp-json\/wp\/v2\/users\/1001"}],"replies":[{"embeddable":true,"href":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/wp-json\/wp\/v2\/comments?post=1586"}],"version-history":[{"count":0,"href":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/wp-json\/wp\/v2\/posts\/1586\/revisions"}],"wp:attachment":[{"href":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/wp-json\/wp\/v2\/media?parent=1586"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/wp-json\/wp\/v2\/categories?post=1586"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/wp-json\/wp\/v2\/tags?post=1586"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}