Research on Drug GMP Supervision System of China and Recommendations

OBJECTIVE To analyse problems in supervision system of Good Manufacturing Practice (GMP) for drugs and to propose policy suggestions.METHODS Literature review,field research and comparative study were adopted to analyse current situation and problems from the aspects of supervision idea,regulation system,inspection organization and personel,supervision mechanism and illegal punishment measures,etc.RESULTS Drug administration was not fully aware of supervision concept.And there were problems such as insufficient of guideline,inconformity of institution construction,difficulty of inspector management,low transparency of law enforcement and lack of flexible punishment.CONCLUSION It is suggested to learn from international experiences and establish a scientific supervision concept,harmonize relevant regulations,strengthen construction of institutions and personnel,complete monitor mechanism,specify punishment measures to improve GMP supervision system.