ABSTRACT
OBJECTIVE： To provide reference for ensuring clinical drug safety and promoting the development of characteristic chemical preparations in medical institutions. METHODS： From three aspects such as registration declaration of new preparations， supplementary application declaration and re-registration declaration， the problems found during the technical review of registration of chemical preparation in medical institutions of Guangdong province have been summed up， the causes of above problems also have been analyzed， and the relevant suggestions have been given at the same time. RESULTS & CONCLUSIONS： There were deficiencies in the registration declaration of new preparations， such as insufficient basis for the title， the lack of key process parameters in the study of preparation process and the failure of stability test conditions to meet the requirements of the Pharmacopoeia， etc. There were deficiencies in the supplementary application declaration， such as the unreasonable formulation of drug， the interaction between the drugs packing material and the drug， and unreasonable setting of storage conditions. There were deficiencies in the re-registration declaration， such as the supply of existing drugs on the market， the lack of production conditions for the formulation unit， the inability to purchase the original excipient materials， and the incomplete attention items. The main reasons were that the lack of technical guidelines for the research of chemical preparations， imperfection of the Standards for the Quality Management of Pharmaceutical Preparation in Medical Institutions and authorized preparation of chemical agents not allowed in Measures for the Registration and Administration of Pharmaceutical Preparation in Medical Institutions， and some kinds of chemical preparations could not adapt to the development of the new situation. The solutions are to improve the regulations of medicinal preparation in medical institutions and develop chemical preparations selectively based on safety and efficiency. In the future， the problems can be solved by formulating the technical guidelines for the research of chemical preparations in medical institutions， refining the rules for the retention of samples in finished products， increasing the requirements for continuous stability inspections， allowing authorized chemical preparations to be commissioned and prepared， phasing out the chemical preparations that do not adapt to the new situation， and developing valuable chemical preparations， to provide safe and effective chemical preparations for clinical use.
ABSTRACT
OBJECTIVE:To provide reference for drug registration declaration. METHODS:The disapproval comments of Chi-na Food and Drug Administration on the declared drugs in Guangdong Province in 2015 were collected,existing problems in cur-rent drug registration declaration in clinical trials stage and registered production stage were analyzed. And suggestions were put for-ward based on relevant policies and regulations. RESULTS & CONCLUSIONS:Reasons for the rejection of declaring chemical drugs in clinical trials stage mainly focused on that there had been imported drugs applied for registration or new drugs entering monitoring period. While pharmacy research quality defects,especially insufficient research in impurities and relevant materials, are the main problems of declaring clinical trials and production. In terms of clinical trail declaration,applicant should respond to new drug registration classification reform,strengthen original innovation development;the development of biological products should establish comprehensive and effective evaluation system to form superior technology and products. In terms of drug registra-tion production declaration,related departments or drug manufacturers should enhance the evaluation for drug form and specifica-tions design,and generic drugs should pay attention to the consistency evaluation with the original research drugs. Besides,the above problems can be solved by conducting scientific and feasible research methods for impurities and related material,and pay at-tention to enlarging research of forward-looking production technology.