Study Chinese GMP Certification System In The Field Of Administrative Law

GMP means "good practice in the manufacturing and quality control of drugs". In china, GMP certification system has been established to oblige the pharmacists to observe GMP.Although GMP certification has achieved certain results, it even has some problems.In the article,the author study GMP certification system in the field of administrative law,and find some defects in the design and the operation of the system,then make a number of ideas in the reconstruction of the system.The article is divided into four parts.In part one,the author analysis some basic concepts,then introduce the progress and the social effects of GMP certification system in china.In part tow,the legal nature of GMP certification has been analysised,then it is concluded that the GMP certification is not the licence but the confirmation in china.In part three,the defects of GMP certification system are listed.First,the imposition of GMP certification is lack of legal basis.Second,as the access standards of pharmacy,the licence system and the GMP certification system are repeated. Third,GMP certification management system is not perfect. At last,the legal responsibilities of the violations of GMP are unreasonable.In part four, the author's view is that GMP certification system needs to be reconstructed under the principle of legitimacy,proportionality,trust protection and power supervision. At the same time,some feasible idea are put forward,such as to cancel the pharmacy licence system,to make GMP certification as a part of the drugs register program,to reform GMP certification management system,to improve GMP certification inspectors system and GMP tracking inspection system,and to reconstruct the legal responsibilities of the violations of GMP.