The newly revised Provisions for Adverse Drug Reaction Reporting and Monitoring was issued on May 24, 2011, and will be put into force on July 1, 2011.

The revised Provisions for Adverse Drug Reaction Reporting and Monitoring comprises 67 articles in eight chapters, including the general provisions, responsibilities, reporting and handling, intensive monitoring, evaluation and control, information management, legal liabilities and supplementary provisions. It gives clearer definitions of the responsibilities of the regulatory departments and Adverse Drug Reaction (ADR) monitoring institutions under provincial level, specifies the procedures and requirements for ADR reporting and makes additional requirements for the investigation, verification and evaluation of serious adverse drug reactions and mass adverse drug events. It adds requirements for intensive drug monitoring and makes clearer and higher requirements for manufacturers to actively carry out ADR monitoring.