It is reported ' Reporter Wang LeMin) The national medicines bad reaction monitoring center issues recently <
" norm " stipulates, when a kind of medicines present one of the the following 6 situations, the national medicines bad reaction monitoring center will start it to monitor especially. These 6 kinds of situations are: The new, serious bad reaction signal appears; The emergence quantity, frequency, crowd of the known bad reaction wait and change suddenly; Present happening suddenly, colony's bad incident; Release warning or take the administrative measure abroad because of security of medicines; Assortment and national medicines bad reaction monitoring center in " the bad reaction information of medicines is notified " think the other situations that needs monitoring especially.
" the norm " stipulate in confirm monitor variety especially, national the intersection of medicines and the intersection of bad reaction and monitoring center send medicines out and monitor and start the notice to enterprises especially. After the medicines manufacturing enterprise receives and starts the notice, should make science, effective, feasible key monitoring scheme immediately, should also finish monitoring especially within time limit that the scheme promises.
The relevant persons in charge of monitoring center of bad reaction of national medicines say, it is safe and effective in order to guarantee listing medicines, the medicines manufacturing enterprise should follow the security information after medicines are listed voluntarily, launch the work of monitoring according to the requirement for " medicines bad reaction report and monitor management ".
Six kinds of signals start medicines to monitor especially safely
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