Malinga ndi "Drug Administration Law of the People's Republic of China" ndi "Vaccine Administration Law of the People's Republic of China", pofuna kuyang'anira ndikuwongolera zochitika za pharmacovigilance za omwe ali ndi chilolezo chogulitsa mankhwala osokoneza bongo komanso olembetsa kulembetsa mankhwala, State Drug. Ulamuliro wakonza ndikukonza "Pharmacovigilance Quality Management The Regulations akulengezedwa, ndipo zofunikira zokhudzana ndi kukhazikitsidwa kwa Pharmacovigilance Quality Management Regulations zikulengezedwa motere:
1. "Pharmacological Vigilance Quality Management Standards" idzakhazikitsidwa mwalamulo pa Disembala 1, 2021.
2. Omwe ali ndi chilolezo chogulitsa mankhwala osokoneza bongo ndi olembetsa kulembetsa mankhwala ayenera kukonzekera mwakhama kukhazikitsidwa kwa "Pharmacological Vigilance Quality Management Regulations", kukhazikitsa ndi kupitiriza kukonza dongosolo la pharmacovigilance monga momwe akufunira, ndikukhazikitsa chitukuko cha pharmacovigilance ntchito.
3. Wopereka chilolezo chogulitsa mankhwala adzamaliza kulembetsa zidziwitso mu National Adverse Drug Reaction Monitoring System mkati mwa masiku 60 kuyambira tsiku lomwe chilengezochi.
4. Akuluakulu oyang'anira mankhwala azigawo azilimbikitsa omwe ali ndi chilolezo chogulitsa mankhwala m'zigawo zawo zoyang'anira kuti akonzekere mwachangu kulengeza koyenera, kukhazikitsa ndi kutanthauzira, kuyang'anira ndi kutsogolera chilolezo chogulitsa mankhwala pogwiritsa ntchito kulimbikitsa kuwunika kwanthawi zonse. Wogwirayo amagwiritsa ntchito "Pharmacological Vigilance Quality Management Regulations" momwe amafunikira, ndipo amasonkhanitsa ndi kubwezeranso malingaliro ndi malingaliro okhudzana ndi nthawi yake.
5. Bungwe la National Adverse Drug Reaction Monitoring Center limalinganiza ndikugwirizanitsa kulengeza, maphunziro ndi malangizo aukadaulo a "Pharmacological Vigilance Quality Management Practices", ndikutsegula ndime ya "Pharmacovigilance Quality Management Practices" patsamba lovomerezeka kuti ayankhe mafunso okhudzana ndi izi. maganizo pa nthawi yake.
Chilengezo chapadera.
