China's SFDA To Set Up System For New Drug Application, Approval And Appraisal
This article was originally published in PharmAsia News
Executive Summary
China's State FDA has released 44 drug databases to publicize all China-marketed drugs on its official website (http://www.sda.gov.cn/). The public can check 980,000 drug items, as well as medical devices and health products, for authenticity and effectiveness/functions, before making a purchase. The agency is also building the database for cosmetic products. Information on drug appraisal is now more transparent: companies that submit new drug applications can enquire online about the status during the drugs' prelaunch safety and efficacy appraisal process at the drug evaluation center website (http://www.cde.org.cn/). The major steps of new drug application, appraisal and approval have been fully divided to prevent unrestricted power that may lead to corruption and safety lapses. (Click here for more - Chinese Language)