The new medicines bad reaction reports management is released

The new medicines bad reaction reports management is released
On May 24, Ministry of Public Health issues " medicines bad reaction report and monitor management " revised newly in the form of the 81st order. This " method " will be implemented formally since July 1, " medicines bad reaction report and monitor management " announced on March 4, 2004 will be abrogated at the same time. New " the method " launch the work of monitoring, get high requirement out of voluntarily manufacturing enterprise, and the one that has increased medicines and monitored especially has demanded and verified the requirement commented on through investigation for serious medicines bad reaction, bad incident of colony medicines.
The new " method " stipulates, the medicines manufacturing enterprise should set up specialized agency and allocate a full-time staff and undertake medicines bad reaction report and monitoring, to an example medicines bad reaction death case known, should finish investigating within 15 days; Colony's bad incident of medicines happens, the relevant medicines manufacturing enterprise will be finished investigating within 7 days, should suspend production, sale and use and recall relevant medicines if necessary; Importing medicines and domestic medicines is delayed selling, using or dismissing from the city in the medicines bad reaction of the external cause of border, medicines manufacturing enterprise should written newspaper supervise administration bureau and national medicines bad reaction monitoring center by medicines by national food in the 24 hour after not knowing.
According to the new " method ", the medicines which the medicines manufacturing enterprise should monitor to new medicine during this period and importing medicines in 5 years to monitor especially for the first time.
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