The State Food and Drug Administration issued the "Guidelines for Pharmacovigilance Inspection"

On April 15, the State Food and Drug Administration issued the "Guiding Principles for Pharmacovigilance Inspection" to implement the requirements of the Drug Administration Law of the People's Republic of China and the Vaccine Administration Law of the People's Republic of China on the establishment of a pharmacovigilance system, and to guide the drug supervision and administration departments to scientifically Standardize the development of pharmacovigilance inspections
.
1.
All provincial drug supervision and administration departments should strengthen organization, leadership and overall coordination, establish and improve working mechanisms, promote pharmacovigilance system and capacity building, and comprehensively strengthen all aspects of pharmacovigilance work
.
2.
All provincial drug regulatory authorities should urge and guide drug marketing license holders within their respective administrative regions to further improve the pharmacovigilance system, standardize the development of pharmacovigilance activities, ensure continuous compliance with the "Pharmacovigilance Quality Management Practices", and earnestly implement the main body of pharmacovigilance.
responsibility
.
3.
All provincial drug supervision and administration departments should incorporate the relevant content of pharmacovigilance inspection in their daily supervision work in light of the supervision actuality of their respective administrative regions, formulate inspection plans scientifically, organize their implementation in an orderly and efficient manner, and further refine the relevant work content, Improve relevant work requirements and effectively implement territorial supervision responsibilities
.
4.
This "Guidelines for Pharmacovigilance Inspection" shall come into force on the date of promulgation.
The former State Food and Drug Administration issued the "Guidelines for Printing and Distributing Adverse Drug Reaction Reports and Monitoring and Inspection by the former State Food and Drug Administration on July 2, 2015 (for Trial Implementation)" Circular of the People’s Republic of China (Food and Drug Administration, Yaohuajian [2015] No.
78) will be repealed at the same time
.
Annex: Guidelines for Pharmacovigilance Testing