Ngokutsho "kweDrug Administration Law of the People's Republic of China" kunye ne "Vaccine Administration Law of the People's Republic of China", ukwenzela ukulawula kunye nokukhokela imisebenzi ye-pharmacovigilance yabanini bagunyaziso lokuthengisa iziyobisi kunye nabafaki-zicelo bokubhaliswa kweziyobisi, i-State Drug. Ulawulo luququzelele kwaye lwaqulunqa "uLawulo loMgangatho we-Pharmacovigilance Le Regulations iyabhengezwa, kwaye imiba efanelekileyo malunga nokuphunyezwa kwe-Pharmacovigilance Quality Management Regulations ibhengezwa ngolu hlobo lulandelayo:
1. I-"Pharmacological Vigilance Quality Management Standards" iya kuphunyezwa ngokusesikweni ngomhla woku-1 kuDisemba, ngowama-2021.
2. Abanini begunya lokuthengisa iziyobisi kunye nabafaki-zicelo bokubhaliswa kweziyobisi baya kulungiselela ngenkuthalo ukuphunyezwa kwe "Pharmacological Vigilance Quality Management Regulations", ukuseka nokuphucula ngokuqhubekayo inkqubo ye-pharmacovigilance njengoko kufuneka, kwaye ulungelelanise uphuhliso lwemisebenzi ye-pharmacovigilance.
3. Umnini wogunyaziso lokuthengisa iziyobisi uya kugqiba ubhaliso lolwazi kwiNkqubo yeSizwe yokuHlola iDrug Reaction Monitoring phakathi kweentsuku ezingama-60 ukususela kumhla wesi saziso.
4. Iziphathamandla zolawulo lweziyobisi kwiphondo ziya kubongoza abanini-zigunyaziso zokuthengisa amachiza kwiingingqi zabo zolawulo olufanelekileyo ukuba balungiselele upapasho olufanelekileyo, ukuphunyezwa kunye nokutolikwa, kwaye babeke iliso kwaye bakhokele ugunyaziso lwentengiso yeziyobisi ngokomeleza uhlolo lwesiqhelo. Umnini uphumeza i-"Pharmacological Vigilance Quality Management Regulations" njengoko kufuneka, kwaye uqokelela aze anike umva imiba enxulumeneyo kunye nezimvo ngexesha elifanelekileyo.
5. Iziko leSizwe lokuJonga i-Adverse Drug Rection Monitoring Centre ngokufanayo liququzelela kwaye linxibelelanise ukupapashwa, uqeqesho kunye nesikhokelo sobuchule se-"Pharmacological Vigilance Quality Management Practices", kwaye livula ikholam ethi "Pharmacovigilance Quality Management Practices" kwiziko lewebhu laseburhulumenteni ukuphendula imibuzo enxulumene noko. izimvo ngexesha elifanelekileyo.
Isaziso esikhethekileyo.
