Analysis and Suggestions of the Existing Problems in Drug Registration Declaration in Guangdong Province / 中国药房

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.