Discussion on Relevant Issues of Medical Institution Preparation Registration Management Approach( Trial) / 中国药房

OBJECTIVE:To provide reference for improving registration regulation of medical institution preparation and pro-moting the development of it. METHODS:According to sorting out and summarizing the Medical Institution Preparation Registra-tion Management Approach(trail)contents,for its shortcomings in terms of medical institution preparation definitions,related im-provement suggestions were put forward. RESULTS & CONCLUSIONS:The Medical Institution Preparation Registration Manage-ment Approach(trail)has promulgated for 12 years from 2005 till now,existing shortcomings were that the definition of medical institution preparations was too wide,requirement on data of application and registration was less rigorous,regulation of clinical re-search was vague,clinical application re-evaluation was inadequate,disapproved case was lacked. In view of the above shortcom-ings,it is suggested to narrow the definition of medical institution preparations,modify the requirement on data of application and registration specify the regulation of clinical research,add monitoring period for the new preparation and update the disapproved case,so as to improve the registration regulation of medical institution preparations and promote the development of preparations in medical institutions.

Discussion on the Problems and Countermeasures of the Preparation Registration in Medical Institutions in Liaoning / 中国药房

OBJECTIVE:To standardized declaration of preparation registration in medical institutions. METHODS:With the combination of registration review of new varieties in the preparation registration in medical institutions in Liaoning province from 2010 to 2014,the existing problems in drug registration information of preparation in medical institutions were introduced,and the solutions and suggestions were proposed. RESULTS & CONCLUSIONS:The main problems of registration information of prepara-tion in medical institutions included non-standardized preparation name,unclear topic and writing,inappropriate instructions and la-bels,and imperfect preparation process,etc. To standardize the preparation registration authenticity and integrity of registration in-formation of medical institutions,it is suggested to increase on-site verification efforts,strengthen the five years clinical using his-torical inspection,improve the level of research and development of hospital preparations declaration units,and strengthen the idea that the medical institutions should be responsible for the quality and safety of preparations to ensure the safety and effectiveness.