对新修订《药品管理法》及其配套法规有关问题的研讨

Discussion on the Newly Revised Drug Administration Law and Related Regulations

本文对新修订的《药品管理法》及其配套法规中关于药品、药品标准、药品批准文号、假药、劣药以及药品监督部门的“配合”职能等定义及相关规定进行了研讨 ,认为有必要对这些定义、规定进行适当的修改 ,以适用于新形势下的药品监督管理工作。

This article discussed the definitions of drug, standard specification, the permitted number of drug, counterfeiting drug, inferior drug, and drug supervision, etc., in the newly revised Drug Administration Law and related regulations. It is necessary to make appropriate revision on these definitions and related regulations to meet the demands of the drug supervision and administration under the new situation.