Abstract: Objectiv eTo make comments on MedDRA coding in case reports of Chinese drugs in order to provide reference for Chinese marketing authorization holders (MAHs) in the process of reporting adverse reactions with the Medical Dictionary for Regulatory Activities (MedDRA) as the standard term set. Methods The essential conditions, general principles and considerations related to MedDRA coding in adverse reaction reports were specified, and recommendations were made on MedDRA coding. Result and Conclusions With the extensive use of MedDRA in China, it is recommended that drug regulatory authorities release unified principles on the use of MedDRA in China in conjunction with the related requirements on term selection by the Maintenance and Support Services Organization(MSSO).

Key words: adverse drug reaction report, MedDRA, coding, MAHS