Ho ea ka "Molao oa Tsamaiso ea Lithethefatsi oa People's Republic of China" le "Vaccine Administration Law of the People's Republic of China", e le ho laola le ho tataisa mesebetsi ea pharmacovigilance ea ba nang le tumello ea ho rekisa lithethefatsi le bakopi ba ngoliso ea lithethefatsi, State Drug. Tsamaiso e hlophisitse le ho theha "Pharmacovigilance Quality Management Melawana e phatlalatsoa, ​​mme litaba tse amehang mabapi le ts'ebetsong ea Melao ea Tsamaiso ea Boleng ba Pharmacovigilance li phatlalatsoa ka tsela e latelang:

1. "Pharmacological Vigilance Quality Management Standards" e tla kengoa tšebetsong ka molao ka la 1 Tšitoe 2021.

2. Ba nang le tumello ea ho rekisa lithethefatsi le bakopi ba ngoliso ea lithethefatsi ba tla itokisetsa ka mafolofolo ho phethahatsa "Pharmacological Vigilance Quality Management Regulations", ho theha le ho tsoela pele ho ntlafatsa tsamaiso ea pharmacovigilance kamoo ho hlokahalang, le ho tiisa nts'etsopele ea mesebetsi ea pharmacovigilance.

3. Ea nang le tumello ea ho bapatsa ka lithethefatsi o tla tlatsa ngoliso ea tlhahisoleseding ho National Adverse Drug Monitoring System nakong ea matsatsi a 60 ho tloha ka letsatsi la phatlalatso ena.

4. Ba boholong profinseng ea taolo ea lithethefatsi ba tla khothaletsa ba nang le tumello ea ho rekisa lithethefatsi libakeng tsa bona tsa tsamaiso ho itokisetsa ka matla phatlalatso e amehang, ts'ebetsong le tlhaloso, le ho laola le ho tataisa tumello ea thekiso ea lithethefatsi ka ho matlafatsa litlhahlobo tsa kamehla. Mong'a eona o kenya tšebetsong "Pharmacological Vigilance Quality Management Regulations" kamoo ho hlokahalang, 'me o bokella le ho fana ka maikutlo a litaba le maikutlo a amanang le ona ka nako.

5. Setsi sa Naha sa Tlhokomelo ea Boemo ba Lithethefatsi Ka mokhoa o tšoanang se hlophisa le ho hokahanya phatlalatso, koetliso le tataiso ea botekgeniki ea "Pharmacological Vigilance Quality Management Practices", 'me e bula kholumo ea "Pharmacovigilance Quality Management Practices" webosaeteng ea semmuso ho araba lipotso tse amanang le tsona. maikutlo ka nako e nepahetseng.

Tsebiso e khethehileng.