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NMPA Promulgated the Guidelines for Clinical Safety Literature Evaluation of Marketed Drugs (Interim)

CCFDIE| Updated: 2019-07-18

To further implement the principal responsibility of drug safety by drug Marketing Authorization Holders (including pharmaceutical manufacturing enterprise holding the drug approval proof documents, hereinafter referred to as the Holders), elevate the ability of the Holders to perform their duties, and regulate the holders to perform systematic review on clinical safety literature, NMPA organized the formulation of the Guidelines for Clinical Safety Literature Evaluation of Marketed Drugs (Interim), which was issued on June 18, 2019.

The Article 4 of the CNDA Announcement on the Direct Reporting of Adverse Reactions by Marketing Authorization Holders (No. 66 of 2018) stipulates that holders should regularly evaluate the ADR Monitoring data, clinical research, literature, etc. Clinical safety literature evaluation of marketed drugs, as one of the major methods for post- marketing clinical research, refers to the process of collection, as systematic and comprehensive as possible, of relevant clinical safety research literatures for specific marketed drugs within a certain time frame; the systematic screening, data extraction, quality evaluation, induction and collation of literature; and thence the qualitative or quantitative comprehensive analysis and evaluation, leading to the formation of evaluation reports. The basic elements of literature evaluation include the general process, methodological points, and written norms of evaluation report.

Drawing on the continuous updating concepts and methods of evidence- based medical evidence classification, grading, and rigorous evaluation, with reference to the indicators and forms of the comprehensive evaluation of health technology, the Guidelines introduces the standardized operation process and the whole process of quality control methods of Cochrane Systematic Review, aiming to provide guidance for drug Marketing Authorization Holders (hereinafter referred to as Holders) to carry out clinical safety literature evaluation and write related reports for marketed drugs (incl. TCM, chemicals and biologicals).