A Prospective Study on the Establishment of International Standards for GRP-ICM and GQP-ICM

Objective In order to promote the construction of scientific research institutions of TCM in the world and to raise the vitality of the institutions, a prospective study has been done on the establishment of the international standards for the research institutions and quality management, namely, Good Research Practice – Institution of Chinese Medicine ( GRP-ICM ) and Good Quality Practice – Institution of Chinese Medicine ( GQP-ICM ). Methods The document analysis, questionnaire, and experts' consultation were adopted to solicit the opinions on the establishment of international standards for the research institutions and quality management. A total of 74 experts from 22 countries and regions (including China) participated in the questionnaire survey, and 30 experts from 11 countries and regions received the consultations and interviews. Results In the survey, 85.14% of the experts (63/74 experts)considered that it is necessary to establish the unified international standards; 90.00% appraised GRP-ICM excellent and 80.00% appraised GQP-ICM goods; and 93.10% thought that these two standards can be implemented or can be implemented after revision. Conclusion This is a prospective study on the establishment of international standards for the research institutions and quality management, with a preliminary understanding of the basic framework, main contents and formulating principles. It lays a solid foundation for the establishment and implementation of the unified international standards for the research institutions and quality management.