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SFDA held videoconference on implementing Provisions for Adverse Drug Reaction Reporting and Monitor
    Pubtime: 2011-07-04

  The newly revised Provisions for Adverse Drug Reaction Reporting and Monitoring will come into effect on July 1, 2011. The State Food and Drug Administration (SFDA) held a videoconference for implementing the Provisions for Adverse Drug Reaction Reporting and Monitoring on June 24, 2011, requiring drug regulatory departments at all levels to fully understand the importance of adverse drug reaction (ADR) monitoring in ensuring drug safety for the public, to pay adequate attention to the publicity and training of the Provisions, to establish and improve the ADR reporting and evaluation system according to the requirements of the Provisions, to do well in the precaution, investigation and disposal of drug safety events, and to do the work of ADR monitoring conscientiously. Wu Zhen, Deputy Commissioner of SFDA was present at the conference and made a speech.

  The newly revised Provisions for Adverse Drug Reaction Reporting and Monitoring defines responsibilities of the drug regulatory departments and adverse drug reaction monitoring institutions under the provincial level, further standardizes the reporting and disposal of adverse drug reaction, makes additional requirements for the investigation, verification and disposal of mass adverse drug events, introduces the system of intensive monitoring, strengthens the surveillance and study of drug safety, emphasizes the role of drug manufacturers in the reporting and monitoring of ADR, and adds content on the information management of ADR.

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