我国进口药品监督检验制度的研究

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。

Study of the Supervision and Inspection System for Imported Drugs in China

Objective To investigate the implemetation of relevant issuses of the imported drug inspection system in our country, and provide references and recommendations for CFDA to revise the Drug Administration Law of the People＇s Republic of China and related laws and regulations. Methods Based on practical challenges that the food and drug inspection agencies and inspection offices for imported drugs encountered, the questionnaire survey and on-site research as well as a comprehensive analysis of the issues and causes were conducted. Results There were many differences in inspections of imported drugs and domestic drugs. Conclusion The imported drug issues are affected by relationships and interests between nations, customs, importers and foreign manufacturers. Therefore, specific and defined laws and regulations should be established for inspection of imported drugs to ensure the safety, efficacy and controllability of imported drugs.