ObjectiveThe guideline is formulated to standardize the principles, procedures and methods of developing therapeutic drug monitoring (TDM) guidelines and to promote open, transparent, scientific and credibility of the TDM guidelines.MethodsDivision of Therapeutic Drug Monitoring, Chinese Pharmacological Society established guideline working groups, declared and managed conflict of interest. The guideline working groups used the Delphi method to formulate the purpose and scope of the guideline and questions in PICO format, searched and synthesized evidence, integrated with Chinese actual situation and TDM characteristics to preliminarily develop recommendations for the guideline for TDM guideline development in China. Through internal discussion of the guideline working groups and external peer review, the content has been improved, and we eventually formulated the guideline suitable for guiding TDM related guidelines development.ResultsThe guideline provide suggestions for problems to be identified and solved in the planning, development, publishing and updating stages of TDM guidelines including forming guideline wording groups, planning guidelines, declaration and management of interests, formulating questions and selecting outcomes, preparing the planning proposal, retrieval and synthesis evidence, evaluating evidence, developing recommendations, drafting guidelines, external review, publishing and spreading guidelines, evaluating guidelines, and updating guidelines.ConclusionsThis guideline can provide methodological guidance and reference for the development of TDM guidelines.