The National Medical Products Administration ("NMPA") has recently enacted and issued the Guiding Principles for Assessment of Literature on Clinical Safety of Marketed Drugs (for Trial Implementation) (the "Principles").
The Principles expressly state that assessment of literature on clinical safety of marketed drugs is one of major approaches for clinical studies conducted after drugs have been launched on the market, and essential elements of such assessment include general procedures for literature assessment, methodological key points, and norms in relation to preparation of assessment reports. The Principles refer to indicators and forms used in an integrated assessment of medical technologies under the medical technology assessment process, and reflect the standard operating procedures and methods for whole-process quality control adopted in systematic Cochrane reviews. In addition, the Principles note that for assessment of literature on clinical safety of marketed drugs that is initiated or sponsored by enterprises, analysis of monitoring data on drug adverse effects should be a part of such assessment. Even though details of certain individual reports do not tally with the facts, such reports cannot be ignored. Instead, causality assessment should be carried out to find out about the adverse effects/events, according to the names of drug adverse effects set out in the guides and norms concerning monitoring of drug adverse effects.