中美新药保护政策及其比较研究

New Drug Protection Policies in China and the U.S.A and the Comparison

本文简要介绍了FDA对药品市场独占权的规定。并将其与中国的新药保护政策进行比较分析。就如何加强中国的新药保护提几点建议。

The authors briefly introduced FDA's regulations on new drug exclusivity and compared them with China's new drug protection policies. The authors also give some suggestions on how to improve new drug protection in China.