摘要
目的:探讨药品数据保护在我国的发展。方法:比较美国和欧盟药品数据保护的具体措施,分析我国药品数据保护的不足, 并提出建议。结果与结论:我国目前尚处于药品数据保护的初级阶段,政府和药品监督管理部门应借鉴欧、美等国的经验,制订明确 的药品数据保护的实施细则。
OBJECTIVE: To discuss the development of drug data protection in China. METHODS: The specific data protection measures taken by United States (US) and the European Union (EU) were compared and the drawbacks of China drug data protection were analyzed; then some suggestions were put forward. RESULTS & CONCLUSION: The drug data protection in China is still only in its infancy. The Chinese government and drug administration should work out definite drug data protection bylaws by drawing experiences from US and EU.
出处
《中国药房》
CAS
CSCD
北大核心
2005年第21期1606-1608,共3页
China Pharmacy
关键词
药品
数据保护
注册
药品研发
Drugs
Data protection
Registration
Drug Research and Development