Ngokuvumelana ne "Drug Administration Law of the People's Republic of China" kanye "noMthetho Wokulawulwa Kokugoma wePeople's Republic of China", ukuze kulawulwe futhi kuqondiswe imisebenzi yokuqapha kwemithi yabanikazi bemvume yokuthengisa izidakamizwa kanye nabafaka izicelo zokubhaliswa kwezidakamizwa, i-State Drug. Ukuphatha kuhlele futhi kwakha "Ukuphathwa Kwekhwalithi Ye-Pharmacovigilance Imithetho iyamenyezelwa, futhi izindaba ezifanele eziphathelene nokuqaliswa kwe-Pharmacovigilance Quality Management Regulations zimenyezelwa kanje:
1. "I-Pharmacological Vigilance Quality Management Standards" izosetshenziswa ngokusemthethweni ngomhla ka-1 Disemba 2021.
2. Abanikazi abagunyaza ukumaketha kwezidakamizwa kanye nabafake izicelo zokubhaliswa kwezidakamizwa bayolungiselela ngokuqhubekayo ukuqaliswa "kweMithethonqubo Yokulawulwa Kwekhwalithi Yezokwelapha", basungule futhi baqhubeke bethuthukisa uhlelo lokuhlolwa kwemithi njengoba kudingekile, futhi bamise ukuthuthukiswa kwemisebenzi yokuhlolwa kwemithi.
3. Umnikazi ogunyazwe ukumakethwa kwezidakamizwa uzoqedela ukubhaliswa kolwazi ku-National Adverse Drug Reaction Monitoring System zingakapheli izinsuku ezingu-60 kusukela ngedethi yalesi simemezelo.
4. Iziphathimandla ezilawula izidakamizwa zesifundazwe zizonxusa abanikazi begunya lokumakethwa kwezidakamizwa ezifundeni zabo zokuphatha ezifanele ukuthi balungiselele ukusakazwa okufanelekile, ukuqaliswa nokuchazwa, futhi baqondise futhi baqondise ukugunyazwa kokumakethwa kwezidakamizwa ngokuqinisa ukuhlola okujwayelekile. Umnikazi usebenzisa "Imithetho Yokulawulwa Kwekhwalithi Ye-Pharmacological Vigilance" njengoba kudingekile, futhi aqoqe futhi anikeze impendulo ngezinkinga nemibono ehlobene ngesikhathi.
5. Isikhungo Sikazwelonke Sokuqapha Ukusabela Kwezidakamizwa sihlela futhi sixhumanise ngokufanayo ukwaziswa, ukuqeqeshwa kanye neziqondiso zezobuchwepheshe ze-"Pharmacological Vigilance Quality Management Practices", futhi sivula ikholamu ethi "Pharmacovigilance Quality Management Practices" kuwebhusayithi esemthethweni ukuphendula imibuzo ehlobene futhi. imibono ngesikhathi.
Isimemezelo esikhethekile.
