New era of drug innovation in China

• 来源期刊: 药学学报（英文版）
• 年，卷（期）: 2019,（5）
• 所属期刊栏目: Policy Forum
• 页码范围: 1084-1085
• 页数: 2页
• 语种: 英文

摘要

In 2018, the China National Medical Products Administration (NMPA) approved new drug applications (NDAs) of 48 new drugs, which was the highest annual approval rate by the Chinese regulatory agency in the past 20 years.Nine of the 48 new drugs,including fruquintinib, anlotinib, toripalimab and sintilimab, are global new molecular entities (NME) that were developed by Chinese pharmaceutical companies.Chinese regulatory reform since 2015 has enabled increased innovative drug research and development in China.Over a hundred drug-related administrative laws, regulations and guidelines have been issued by the Chinese central government and the NMPA (formerly CFDA before 2018) since 2015, which has unleashed a new era of drug innovation in China.