electronic regulation for the pharmaceutical manufacturers
Recently, China Food and Drug Administration (CFDA) has released an announcement on the electronic regulation for the pharmaceutical manufacturers (No.1,2015), demanding full-scaled enforcement of the regulation of the pharmaceutical preparation, whole procedure of the production and circulation by the end of 2015.
According to the announcement, domestic pharmaceutical manufacturers and importing pharmaceutical manufacturers must get access to Chinese drug electronic administration network (hereinafter referred to network access) by Dec. 31, 2015, as per the direction of the original ‘working guidance on the electronic supervision on drugs ‘issued by CFDA, the identification of Chinese drug electronic supervision code(hereinafter referred to code) should be printed and stuck on all-levels sales package, the data and inspection on the log-in and log-out should be uploaded through Chinese drug electronic administration platform. All codes of the pharmaceutical preparations produced after Jan.01, 2016 should be printed.
Before Dec 31，2015，all pharmaceutical wholesale and retail enterprises must access to the network. The GSP amendment should be strictly followed and the enterprises should scan codes on all their products, inspect log in and out, upload data in time, make sure the completion and accuracy of data and seriously process warning information in the pharmaceutical electronic supervision system.
Before Apr 30, 2015, importing pharmaceutical manufacturers who have not yet accessed to the network should report to CFDA on their designated agent of electronic drug administration. They should launch their work of network access under the direction of ‘working guidance of the electronic supervision on drugs ‘issued by CFDA (No.23, 2013).
Under the deployment of provincial food and drug administration department, pharmaceutical production or managerial enterprises and importing drug electronic administration agents should actively participate in the training program, optimize devices and systems, rationalize the operation process and implement the work in accessing to the network ,printing the code, uploading data and inspecting log in and out as per the directions .