Raws li "Drug Administration Law of the People's Republic of China" thiab "Vaccine Administration Law of the People's Republic of China", txhawm rau tswj thiab coj cov haujlwm pharmacovigilance ntawm kev tso cai muag tshuaj thiab cov neeg thov sau npe tshuaj, Lub Xeev Cov Tshuaj Kev tswj hwm tau tsim thiab tsim "Pharmacovigilance Quality Management Cov Kev Cai tau tshaj tawm ntawm no, thiab cov teeb meem cuam tshuam txog kev ua raws li Pharmacovigilance Quality Management Regulations tau tshaj tawm raws li hauv qab no:

1. "Pharmacological Vigilance Quality Management Standards" yuav raug ua raws li lub Kaum Ob Hlis 1, 2021.

2. Cov neeg tuav pov hwm kev lag luam muag tshuaj thiab cov neeg thov sau npe tshuaj yuav tsum ua tib zoo npaj rau kev ua raws li "Pharmacological Vigilance Quality Management Regulations", tsim thiab txuas ntxiv txhim kho cov txheej txheem pharmacovigilance raws li qhov yuav tsum tau ua, thiab ua qauv kev txhim kho ntawm cov dej num pharmacovigilance.

3. Tus tuav ntaub ntawv tso cai muag tshuaj yuav tsum ua kom tiav cov ntaub ntawv sau npe hauv National Adverse Drug Reaction Monitoring System hauv 60 hnub txij li hnub tshaj tawm no.

4. Lub xeev cov cai tswj xyuas cov tshuaj yeeb tshuaj yuav tsum yaum cov neeg tuav pov hwm kev lag luam tshuaj nyob rau hauv lawv cov cheeb tsam tswj hwm kom nquag npaj rau kev tshaj tawm, kev siv thiab kev txhais lus, thiab saib xyuas thiab coj cov kev tso cai muag tshuaj los ntawm kev ntxiv dag zog rau kev tshuaj xyuas niaj hnub. Tus tuav ntaub ntawv siv "Pharmacological Vigilance Quality Management Regulations" raws li qhov yuav tsum tau ua, thiab sau thiab xa rov qab cov teeb meem ntsig txog thiab kev xav hauv lub sijhawm.

5. Lub National Adverse Drug Reaction Monitoring Center sib koom ua ke thiab tswj xyuas kev tshaj tawm, kev cob qhia thiab kev cob qhia ntawm "Pharmacological Vigilance Quality Management Practices", thiab qhib "Pharmacovigilance Quality Management Practices" kem ntawm lub vev xaib official los teb cov lus nug ntsig txog thiab kev xav hauv lub sijhawm.

Kev tshaj tawm tshwj xeeb.