A letter from the Provincial Food and Drug Administration to the holders of drug marketing licenses across the province!

The "Pharmacological Vigilance Quality Management Regulations" of the State Drug Administration will be officially implemented on December 1, 2021.

A letter to the province’s drug marketing authorization holders

Holders of each drug marketing authorization:

In accordance with the requirements of the Announcement (No.

1.

2.

3.

4.

5.

6.
Whether the master file of the pharmacovigilance system has been created ;

7.
Are you ready to carry out new tasks such as signal detection, risk identification, risk assessment, risk control and risk communication ;

8.
Whether to formulate and implement a pharmacovigilance plan based on the results of the drug risk assessment ;

9.
Whether the training on pharmacovigilance related regulations and knowledge has been carried out in accordance with the requirements ;

10.
Whether to register and update product information in the national adverse drug reaction monitoring system, and enter the information of the person in charge of pharmacovigilance ;

11.
Whether to audit the newly established or perfect pharmacovigilance system
.

All holders must pay attention to the above content and must comply with the requirements of the "Pharmacological Vigilance Quality Management Regulations"
.
At the same time, it is necessary to promptly follow up the release of supporting guidance documents of the Pharmacovigilance Quality Management Practices of the State Drug Administration and the Evaluation Center of the State Drug Administration, and continuously update and improve the pharmacovigilance system to ensure that pharmacovigilance activities continue to meet the requirements of laws and regulations
.

Provincial central technical guidance and consultation telephone: 0531-88592716, 88592704
.

Shandong Adverse Drug Reaction Monitoring Center

November 30, 2021