Notice On Doing A Good Job In Monitoring Adverse Drug Reaction Events Of Medical Institutions In The Hainan Boao Lecheng International Medical Tourism Pioneer Zone (Final)

Notice on Doing a Good Job in Monitoring Adverse Drug Reactions/Events of Medical Institutions in the Hainan Boao Lecheng International Medical Tourism Pioneer Zone

Medical institutions in Hainan Boao Lecheng International Medical Tourism Pioneer Zone: To standardize the monitoring of adverse drug reactions and medical device adverse events in the Hainan Boao Lecheng International Medical Tourism Pilot Zone (hereinafter referred to as the pilot zone), especially to strengthen the monitoring of adverse reactions/events of clinically urgently needed licensed imported drugs and medical devices, and timely and effective control of drug use According to the “Drug Administration Law”, “Regulations on the Supervision and Administration of Medical Devices,” “Administrative Measures for Adverse Drug Reaction Reporting and Monitoring”, “Administrative Measures for Monitoring and Re-evaluation of Medical Device Adverse Events (for Trial Implementation),” Hainan Provincial People’s Government on the issue of Hainan According to relevant laws and regulations, such as the Notice of the Interim Regulations on the Management of Urgently Needed Imported Medical Devices in the Boao Lecheng International Medical Tourism Pioneer Zone, medical institutions in the Pioneer Zone shall carry out monitoring of adverse drug reactions/events in accordance with the following requirements.