Adhering to patient orientation, China has introduced a series of policies in recent years to accelerate marketing of imported pharmaceutical products, accelerate review and approval of clinically imperative pharmaceutical products, and promote the marketing in China of the new drugs marketed overseas ASAP.

A memorandum of policies
The State Council of China issued the Opinions on the Reform of Review and Approval System for Drugs and Medical Devices in Aug. 2015;
The General Office of the Communist Party of China Central Committee and General Office of the State Council of China issued the Opinions on Deepening the Reform of the Review and Approval System and Inspiring Innovation of Drugs and Medical Devices in Oct. 2017;
The former China Food and Drug Administration issued the Opinions of China Food and Drug Administration on Encouraging Priority Review and Approval for Drug Innovation in Dec. 2017;
The NMPA issued the Announcement on Matters concerning Customs Clearance and Inspection of Imported Chemical Drugs in Apr. 2018;
The NMPA and NHC issued the Announcement on Matters concerning the Optimization of Drug Registration Review and Approval in May 2018;
The NMPA issued the Announcement on Adjusting the Review and Approval Procedures for Drug Clinical Trials (No. 50 of 2018) in July 2018;
The Center for Drug Evaluation (CDE) of the NMPA issued the Notice on Soliciting Opinions on the List of Clinically Imperative New Drugs that are Marketed Overseas in Aug. 2018.
Imported Drugs Approved through Priority Review in 2018
According to my preliminary statistics, there were 25 imported drugs approved for marketing through priority review in 2018, accounting for about half of the newly approved varieties (refer to Table 1 for the details).
Table 1 Imported Drugs Approved through Priority Review in 2018
NO | Item name | Approval date | Company name | Reason |
1 | Pertuzumab Injection | Dec. 17, 2018 | Roche | Innovative drug with significant therapeutic advantages |
2 | Emicizumab Injection | Nov. 30, 2018 | F. Hoffmann-La Roche | Clinically imperative rare disease drug |
3 | Lacosamide Tablets | Nov. 21, 2018 | UCB Pharma SA | Innovative drug with significant therapeutic advantages |
4 | Ceritinib Capsules | Oct. 31, 2018 | Novartis | Innovative drug with significant therapeutic advantages |
5 | Rasburicase for Injection | Oct. 15, 2018 | Sanofi | Pediatric drug |
6 | Olodaterol Inhalation Spray | Oct. 15, 2018 | Boehringer Ingelheim | Innovative drug with significant therapeutic advantages |
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