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National Essential Drugs will implement electronic monitoring
6-13-2013
WASHINGTON: Medical Reform Office of the State Council requirements of relevant documents, this year on June 17, the State Food and Drug Administration issued a "basic medicines for all varieties of electronic monitoring work notice" clearly put forward: one, where the production of varieties of essential drugs The successful enterprises should Mar. 31, 2011 to join Drug electronic monitoring network, varieties of essential drugs factory, manufacturers are required to provide for the minimum selling products listed on the packaging printed (stickers) unified identity drug electronic monitoring code, and By monitoring network for data collection and submission; every business enterprise varieties of essential drugs, subject to the provisions of information collection and submitted to the regulatory code. Second, April 1, 2011 onwards, the inclusion of essential drug list of the species, not network and unused drugs electronic monitoring code unified identity, and are not allowed to participate in bidding and purchasing of essential drugs. Third, the essential drug list is not successful manufacturing enterprises varieties of electronic monitoring work, according to the National Bureau of gradual completion of the deployment.
National essential drugs for drug production enterprises, after the implementation of electronic monitoring, drug sales in product packaging minimum uniform logo affixed to drug regulatory code. Both drugs and drug regulatory code tag, but also drugs "identity." Posted drug regulatory code of medicines, truthfully reflect each box, each box, each batch of medicines real production, management, inventory and flow situation, in case the problem can be quickly traced and recalled. The basic drug electronic monitoring allows pharmaceutical companies in the security, Cuanhuo, production management, inventory management, quality traceability, sales flow control and logistics management and other aspects of a higher level.
Production enterprises in different types of packaging endowed, must first join Chinese pharmaceutical electronic monitoring network, purchase endowed facilities to increase personnel. It was carried out by a single species is estimated that the implementation of electronic monitoring code after each smallest packaging of medicines increase costs 4 cents. According to insiders, the meager profits of essential drugs, the cost over one penny is hard to accept. People worried about the same time there is a prominent issue is how much electronic monitoring implementation of the results. From the current policy, the electronic monitoring of essential drugs and not related to drug manufacturing process, so that the consequences will be as long as some inferior drug electronic monitoring code can be pasted into the market fair and square. Also download electronic monitoring code to save and post production into one hundred twenty-three yards must be properly and permanently stored in the company database, because after sampling the pharmaceutical sector, the quality of retrospective, flow management and so need to refer to these data, the company's database will be increasingly large data once came out to the enterprise on behalf of the impact will be huge!
Company to be included in the electronic monitoring of essential drugs have compound reserpine, captopril tablets and other 22 products. Production lines, packaging lines, and require significant adjustment, tablets, injections, storage, etc. must be real-time networking and corporate information terminals to facilitate data capture, upload and management. In order to expedite the implementation of national essential drugs electronic monitoring work, the company arranged a special related personnel to Nanjing to participate in the work of the Provincial Drug electronic monitoring, training and arrange for someone to go to Tianjin Tasly Group study tour to expeditiously implement the base drugs kind of electronic monitoring.
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