NMPA Announcement on Issuing the Good Pharmacovigilance Practice
According to the Drug Administration Law of the People's Republic of China and the Vaccine Administration Law of the People's Republic of China, NMPA has organized to formulate the Good Pharmacovigilance Practice to standardize and guide drug marketing authorization holders and drug registration applicants to conduct pharmacovigilance activities, which was issued on May 7. The issues related to the implementation of the Good Pharmacovigilance Practice are hereby announced as follows:
I. The Good Pharmacovigilance Practice will come into force as of December 1, 2021.
II. Drug marketing authorization holders and drug registration applicants shall actively prepare for the implementation of the Good Pharmacovigilance Practice, establish and continuously improve the pharmacovigilance system and conduct pharmacovigilance activities in a standardized manner.
III. Drug marketing authorization holders shall complete information registration at the National ADR Monitoring System within 60 days upon issuance of this Announcement.
IV. All the provincial medical products administration shall supervise and urge the drug marketing authorization holders within their respective administrative areas to actively make preparations, cooperate with relevant publicity and interpretation, supervise and guide drug marketing authorization holders to implement the Good Pharmacovigilance Practice as required by strengthening routine inspection and other activities, and in a timely manner collect and feedback relevant questions and comments.
V. The National Center for ADR Monitoring shall organize and coordinate the publicity, training and technical guidance for the Good Pharmacovigilance Practice in a unified manner and set a special column of the Good Pharmacovigilance Practiceon its official website to reply to questions and comments in a timely manner.