The National Medical Products Administration ("NMPA") has recently issued the Opinions on Further Strengthening the Building of System and Capacity for Monitoring and Evaluation of Adverse Drug Reactions (the "Opinions").
The Opinions set nine major tasks, including accelerating the improvement of the system for monitoring and evaluation of adverse drug reactions (ADR), researching and exploring new methods for post-marketing monitoring and evaluation of drug safety, and maintaining and consolidating the work mechanism for reporting of ADR by medical institutions. Specifically, the Opinions require accelerated revision of the Administrative Measures for the Reporting and Monitoring of Adverse Drug Reactions, exploration and study on the alert system for monitoring of medical devices, and accelerated formulation of the administrative measures for the monitoring of adverse reactions of cosmetics as well as supporting technical specifications. Drug marketing authorization holders shall perform the responsibility for product safety as main entities in accordance with the law, strengthen the management of the entire life cycle of drugs, medical devices and cosmetics, and establish and improve the system for monitoring and evaluation. In addition, the Opinions also call for efforts to explore new channels for patients to directly report ADR, increase capital investment in the ADR monitoring and evaluation work, and incorporate the monitoring and evaluation system and capacity building into the indicators for annual assessment of local governments.