[Guidelines for post-marketing research on clinical safety of Chinese patent medicines]

Safety research is a central focus of post-marketing drug studies and a critical component of the lifecycle management of pharmaceutical products. Chinese patent medicines are widely used in clinical practice in China due to their clear efficacy and stable dosage forms. However, their post-marketing safety issues have become increasingly prominent. Post-marketing clinical safety research on Chinese patent medicines started relatively late. To enhance its scientific rigor and standardization, Center for Drug Reevaluation, National Medical Products Administration, in collaboration with Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, took the lead in developing the Guidelines for post-marketing research on clinical safety of Chinese patent medicines(hereinafter referred to as the Guidelines). The Guidelines were standardized under the jurisdiction of the China Association of Chinese Medicine and officially released and implemented on the National Group Standards Information Platform. The Guidelines align with advanced concepts and experiences in international post-marketing drug safety research, while fully considering the unique characteristics of safety studies, the national context of China, and the specific attributes of Chinese patent medicines. The Guidelines standardize the core elements of post-marketing clinical safety research on Chinese patent medicines, which include fundamental principles(compliance, scientific rigor, and ethical considerations), decision-making for research topics(timing of initiation, research foundation, research objectives, research questions, and research methods), study design, protocol implementation, quality control, data analysis, and summary reporting. Furthermore, the Guidelines provide methodological guidance for medical research institutions, marketing authorization holders, and pharmaceutical production and distribution enterprises, promoting standardization of research processes and normalization of evidence to enhance clinical decision-making regarding safe medication use.