Investigation and Analysis of New Drugs GMP Implementation Effect

OBJECTIVE To investigate implementation effect of new drugs GMP, analyse problems and propose policy suggestions. METHODS Literature review and questionnaire survey were adopted. The questionnaire included legal construction, law enforcement personnel, supervision and environment. RESULTS Through the questionnaire survey, most respondents thought that regulatory harmonization and practicability should be improved. Speciality and management of inspector should be enhanced. Enforcement was not unified, and information disclosure was insufficient. Some respondents still doubt whether the GMP certification should be eliminated. CONCLUSION Drug administration can strengthen legal construction and raise working efficiency; enhance training and gradually realize full-time inspector; improve enforcement supervision and disclose the inspection information; optimize the resource distribution and set up a favorable environment.