我国药物创新战略背景下数据保护制度的政策选择

Policy selection of regulatory data protection under the background of drug innovation strategy in China

基于我国药物创新的政策环境探讨我国实施药品数据保护制度的现实基础及策略。在鼓励药物创新的政策背景下,我国应科学评估数据保护制度可能会带来的利与弊,权衡其对我国的药物创新、制药产业以及药品可及性和公共健康等方面的影响,构建适合中国国情的药品数据保护制度。

The realistic basis and strategy of implementation of data protection system were explored based on the pharmaceutical innovation policy. It is important to assess impact of data protection on pharmaceutical innovation, domestic pharmaceutical industry, access to new medicines and public health and to develop suitable mech- anisms to protect regulatory data under the background of policy to encourage drug innovation in China.