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目的调研我国进口药品监督检验制度及执行中的有关问题,为修订我国《药品管理法》及相关法律法规提供调查结果和建议。方法采取问卷调查和实地调研的方法,掌握我国食品药品稽查机构和相关进口药品检验所在日常工作中遇到的问题,对信息进行综合分析。结果我国对进口药品和国产药品的监督检验存在着很多差别。结论进口药品涉及到国与国之间、海关与海关之间、进口商和国外生产商之间的关系和利益,为保证进口药品安全、有效、质量可控,对进口药品的监督检验应有明确的法律规定。
Objective To investigate the problems of China’s imported drug supervision and inspection system and its implementation and to provide the survey results and suggestions for the revision of China’s Drug Administration Law and relevant laws and regulations. Methods The methods of questionnaire survey and field investigation were used to master the problems encountered in the daily work of China’s food and drug inspection agencies and related imported drug inspection centers and to make a comprehensive analysis of the information. As a result, there are many differences in the supervision and inspection of imported drugs and domestically produced drugs in China. Conclusion Imported drugs involve the relations and interests between countries, customs and customs, importers and foreign manufacturers. In order to ensure the imported drugs are safe, effective and controlled in quality, the supervision and inspection of imported drugs should be clear The legal provisions.