Zvinoenderana ne "Drug Administration Law yePeople's Republic of China" uye "Vaccine Administration Law yePeople's Republic of China", kuitira kudzora uye kutungamira zviitiko zvepharmacovigilance zvevane mvumo yekushambadzira zvinodhaka uye vanonyorera zvinodhaka, iyo State Drug. Kutonga kwakaronga nekugadzira iyo "Pharmacovigilance Quality Management Iyo Mitemo inoziviswa, uye nyaya dzine chekuita nekuitwa kweiyo Pharmacovigilance Quality Management Regulations zvinoziviswa sezvizvi:

1. Iyo "Pharmacological Vigilance Quality Management Standards" ichaitwa zviri pamutemo muna Zvita 1, 2021.

2. Vane mvumo yekushambadzira zvinodhaka uye vanyoreri vekunyoresa zvinodhaka vachashingairira kugadzirira kuzadzikiswa kwe "Pharmacological Vigilance Quality Management Regulations", gadza uye nekuenderera mberi nekuvandudza pharmacovigilance system sezvinodiwa, uye kuenzanisa kusimudzira kwe pharmacovigilance zviitiko.

3. Mubati wemvumo yekushambadzira zvinodhaka achapedzisa kunyoresa ruzivo muNational Adverse Drug Reaction Monitoring System mukati memazuva makumi matanhatu kubva pazuva rechiziviso ichi.

4. Vakuru vepurovhinzi vanodzora zvinodhaka vachakurudzira vane mvumo yekushambadzira zvinodhaka munzvimbo dzavanotonga kuti vagadzirire kushambadza kwakakodzera, kuita uye kududzira, uye kutarisa nekutungamira mvumo yekushambadzira zvinodhaka kuburikidza nekusimbisa kuongororwa kwemaitiro. Iye anobata anoshandisa iyo "Pharmacological Vigilance Quality Management Regulations" sezvinodiwa, uye anounganidza uye anodzoreredza zvine chekuita nenyaya uye maonero nenguva.

5. National Adverse Drug Reaction Monitoring Center inoronga pamwe chete uye inoronga kushambadzirwa, kudzidziswa uye kutungamira kwehunyanzvi kwe "Pharmacological Vigilance Quality Management Practices", uye inovhura "Pharmacovigilance Quality Management Practices" pawebhusaiti yepamutemo kupindura mibvunzo ine hukama uye maonero panguva.

Chiziviso chakakosha.