Announcement of the State Drug Administration on Issuing the "Pharmacological Vigilance Quality Management Standards" (No. 65 of 2021)

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", in order to regulate and guide the pharmacovigilance activities of drug marketing authorization holders and drug registration applicants, the State Drug Administration has organized and formulated the "Pharmacovigilance Quality Management The Regulations are hereby announced, and the relevant matters concerning the implementation of the “Pharmacological Vigilance Quality Management Regulations” are announced as follows: 1.
The “Pharmacovigilance Quality Management Regulations” will be formally implemented on December 1, 2021
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2.
Drug marketing authorization holders and drug registration applicants shall actively prepare for the implementation of the "Pharmacological Vigilance Quality Management Regulations", establish and continuously improve the pharmacovigilance system as required, and standardize the development of pharmacovigilance activities
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3.
The drug marketing authorization holder shall complete the information registration in the National Adverse Drug Reaction Monitoring System within 60 days from the date of this announcement
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4.
The provincial drug regulatory authorities shall urge the drug marketing authorization holders in their respective administrative regions to actively prepare for the relevant publicity, implementation and interpretation, and supervise and guide the drug marketing authorization through strengthening routine inspections.
The holder implements the "Pharmacological Vigilance Quality Management Regulations" as required, and collects and feeds back related issues and opinions in a timely manner
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5.
The National Adverse Drug Reaction Monitoring Center uniformly organizes and coordinates the publicity, training and technical guidance of the "Pharmacological Vigilance Quality Management Practices", and opens up the "Pharmacovigilance Quality Management Practices" column on the official website to answer related questions and opinions in a timely manner
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Hereby announce
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Attachment: Pharmacovigilance Quality Management Standards National Medical Products Administration May 7, 2021 National Medical Products Administration Announcement No.
65 of 2021 Annex.
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