Unlocking Access To Novel Medicines In China-A Review From A Health System Perspective

Figures & data

Figure 1 Lifecycle regulation of new pharmaceutical products in China.

Figure 2 Milestones and landmark policies to streamline the regulatory process.

Notes: ^aNational Medical Products Administration. Deepening the1 National Medical Products Administration. Deepening the reform of review and approval system and promoting medicines innovation. Document No. 37 of 2013. http://www.nmpa.gov.cn/WS04/CL2196/323982.html (in Chinese, accessed July 30, 2019). ^bThe State Council. Opinions of reforming review and approval systems of medicines and medical devices. Document No. 44 of 2015. http://www.gov.cn/zhengce/content/2015-08/18/content_10101.htm (in Chinese, accessed July 30, 2019). ^cChina Food and Drug Administration. Reducing delay of medicines registration and implementing priority review and approval. Document No. 19 of 2016 (Abolished and replaced by a new document issued in reform of review and approval system and promoting medicines innovation. Document No. 37 of 2013. http://www.nmpa.gov.cn/WS04/CL2196/323982.html (in Chinese, accessed July 30, 2019). ^dThe State Council. Opinions of reforming review and approval systems of medicines and medical devices. Document No. 44 of 2015. http://www.gov.cn/zhengce/content/2015-08/18/content_10101.htm (in Chinese, accessed July 30, 2019). ^eChina Food and Drug Administration. Reducing delay of medicines registration and implementing priority review and approval. Document No. 19 of 2016 (Abolished and replaced by a new document issued in 2017). http://samr.cfda.gov.cn/WS01/CL0844/145260.html (in Chinese, accessed July 30, 2019). ^fThe State Council. Promoting healthy development of the pharmaceutical industry. Document No. 11 of 2016. http://www.gov.cn/zhengce/content/2016-03/11/content_5052267.htm (in Chinese, accessed July 30, 2019). ^gChinese Communist Party Central Committee and State Council. Opinions to deepening the reform of review and approval system and promoting medicines and medical devices innovation. http://www.gov.cn/zhengce/2017-10/08/content_5230105.htm (in Chinese, accessed July 30, 2019). ^hNational Medical Products Administration. Promoting new drug priority review and approval. Document No. 126 of 2017. http://www.nmpa.gov.cn/WS04/CL2196/324193.html (in Chinese, accessed July 30, 2019). ⁱNational Medical Products Administration. Reforming clinical trial review and approval procedures. Announcement No.50 of 2018. http://www.nmpa.gov.cn/WS04/CL2111/329716.html (in Chinese, accessed July 30, 2019).