On August 18, 2005, the State Food and Drug Administration (SFDA) released a notification of national adverse drug reaction (ADR) case reporting for the first half of this year. It indicated a significant increase of ADR case reporting throughout the country.
In the first half of this year, China National Center for Adverse Drug Reaction Monitoring received 36,377 ADR case report forms, including new and serious ADR cases (4.6%). Of the reports, 97.1% are from medical institutions and 2.9% from drug manufactures and distributors. Twenty-eight ADR cases, on average, were reported per million people.
SFDA requires drug regulatory departments at different levels to monitor ADR in accordance with the newly revised Provisions for ADR Reporting and Monitoring.