Reflection on National Drug Standards Management from the Perspective of Whole Lifecycle

OBJECTIVE To provide references for the management of the national drug standards. METHODS Through looking up the literatures, interviewing the experts in the field of drug standards and combining with the practice in drug standard management, the national drug standards were divided into different stages by using lifecycle theory, the characteristics of every stage were summed up and the corresponding management advice were put forward. RESULTS The national drug standards lifecycle was divided into four stages, including standards planning, standards establishment and revision, standards implementation and standards information feedback. Based on the scientific, forward-looking and operational characteristics of the standards planning, combined with the present situation in pharmaceutical industry development in China, clinical medicine and drug regulatory needs, collecting comprehensive pharmaceutical standards requirements and formulating operational and proactive standards planning are advised. For the long cycle of formulating and revising standards, a number of units participated in the research of standards and the time was limited, selecting high-level researching units involved in formulating and revising standards, strengthing the supervision and making performance evaluation should be proposed. In view of the practical, informative and urgent characteristic in national drug standards implementation and feedback, establishing the procedures and converting the reasonable feedbacks to standards or researching projects timely were proposed. CONCLUSION The characteristics of each stage of the national drug standard based on the life cycle theory can provide theoretical references for the practical management of the national drug standard, which is conducive to the formulation of strategies more comprehensive and systematic.