Wahi a ka "Drug Administration Law of the People's Republic of China" a me ka "Vaccine Administration Law of the People's Republic of China", i mea e hoʻoponopono ai a alakaʻi i nā hana pharmacovigilance o nā mea kūʻai aku i ka lāʻau ʻae a me nā mea noi inoa lāʻau, ka State Drug Ua hoʻonohonoho a hoʻonohonoho ka Administration i ka "Pharmacovigilance Quality Management Ua hoʻolaha ʻia nā lula, a ua hoʻolaha ʻia nā mea pili e pili ana i ka hoʻokō ʻana i ka Pharmacovigilance Quality Management Regulations penei:

1. E hoʻokō ʻia ana ka "Pharmacological Vigilance Quality Management Standards" ma Dekemaba 1, 2021.

2. E hoʻomākaukau ikaika nā mea kūʻai aku i ka lāʻau a me nā mea noi e hoʻopaʻa inoa i ka lāʻau no ka hoʻokō ʻana i ka "Pharmacological Vigilance Quality Management Regulations", e hoʻokumu a hoʻomaikaʻi mau i ka ʻōnaehana pharmacovigilance e like me ka mea e pono ai, a e hoʻohālikelike i ka hoʻomohala ʻana i nā hana pharmacovigilance.

3. E hoʻopau ka mea nona ka mana kūʻai lāʻau i ka hoʻopaʻa inoa ʻana ma ka National Adverse Drug Reaction Monitoring System i loko o 60 mau lā mai ka lā o kēia hoʻolaha.

4. E koi aku nā luna hoʻoponopono lāʻau panalāʻau i ka poʻe paʻa i ka mana kūʻai lāʻau lapaʻau ma ko lākou mau wahi hoʻomalu e hoʻomākaukau ikaika no ka hoʻolaha kūpono, ka hoʻokō ʻana a me ka wehewehe ʻana, a e nānā a alakaʻi i ka ʻae kūʻai lāʻau ma o ka hoʻoikaika ʻana i nā nānā maʻamau. Hoʻokō ka mea paʻa i ka "Pharmacological Vigilance Quality Management Regulations" e like me ka mea e pono ai, a hōʻiliʻili a hānai i nā pilikia a me nā manaʻo pili i ka manawa kūpono.

5. Ka National Adverse Drug Reaction Monitoring Center uniformly organizes and coordinate the publicity, training and technical guidance of the "Pharmacological Vigilance Quality Management Practices", a wehe i ka "Pharmacovigilance Quality Management Practices" kolamu ma ka official website e pane i na ninau pili a me nā manaʻo i ka manawa kūpono.

Hoʻolaha kūikawā.