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为了保障本国人民的健康,每个国家的主管部门都制订了新药的管理法规、条例或准则,但由于各个国家的政治、法律、社会经济以及文化教育等条件不同,在理解和制订具体条款上必然存在着差异。即使是一些主要工业国的法规和标准,如果将其比较的话,也有很多不一致的地方。由于这一原因,一个新药在一个或几个国家得到批准,并不一定在其他国家得到通过。这样,在有些情
In order to protect the health of their own people, the competent authorities of each country have formulated the regulations, rules or guidelines for the management of new drugs. However, due to the different political, legal, socio-economic and cultural and educational conditions in various countries, the understanding and formulation of specific provisions There must be differences. Even in the laws and standards of some major industrialized countries, there are many inconsistencies if they are compared. For this reason, a new drug is approved in one or several countries and may not necessarily be adopted in other countries. In this way, in some situations