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 |
7 | Atomoxetine Hydrochloride Oral Solution | Sep. 11, 2018 | Eli Lilly | Pediatric drug |
8 | Buprenorphine Hydrochloride and Naloxone Hydrochloride Sublingual Tablets | Sep. 11, 2018 | Indivior UK Limited | Innovative drug with significant therapeutic advantages |
9 | Eculizumab Injection | Sep. 4, 2018 | Alexion Europe SAS | Clinically imperative pediatric drug and rare disease drug |
10 | Lenvatinib Mesylate Capsules | Sep. 4, 2018 | Eisai | Innovative drug with significant therapeutic advantages |
11 | Olaparib Tablets | Aug. 22, 2018 | AstraZeneca | Innovative drug with significant therapeutic advantages |
12 | Alectinib Hydrochloride Capsules | Aug. 12, 2018 | Roche | Innovative drug with significant therapeutic advantages |
13 | Palbociclib Capsules | July 31, 2018 | Pfizer | Innovative drug with significant therapeutic advantages |
14 | Evolocumab Injection | July 31, 2018 | Amgen | Innovative drug with significant therapeutic advantages |
15 | Pembrolizumab Injection | July 20, 2018 | MSD | Innovative drug with significant therapeutic advantages |
16 | Tiotropium Bromide and Olodaterol Inhalation Spray | July 18, 2018 | Boehringer Ingelheim | Innovative drug with significant therapeutic advantages |
17 | Teriflunomide Tablets | July 18, 2018 | Sanofi | Rare disease drug |
18 | Pediatric Faropenem Sodium Granules | July 5, 2018 | Maruho Co., Ltd. | Pediatric drug |
19 | Nivolumab Injection | June 15, 2018 | BMS | Innovative drug with significant therapeutic advantages |
20 | Delamanid Tablets | May 18, 2018 | Otsuka Pharmaceutical | Innovative drug with significant therapeutic advantages |
21 | Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine | Apr. 28, 2018 | MSD | Innovative drug with significant therapeutic advantages |
22 | Glycopyrronium Bromide Powder for Inhalation, Hard Capsules | Apr. 16, 2018 | Novartis | Innovative drug with significant therapeutic advantages |
23 | Ixazomib Citrate Capsules | Apr. 12, 2018 | Takeda | Innovative drug with significant therapeutic advantages |
24 | Umeclidinium Bromide and Vilanterol Trifenatate Powder for Inhalation | Mar. 12, 2018 | Glaxo Group Limited | Innovative drug with significant therapeutic advantages |
25 | Aflibercept Injection for Intravitreal Injection | Feb. 2, 2018 | Bayer | Innovative drug with significant therapeutic advantages |
About the Author:
zhulikou431
Zhulikou431, as a senior engineer, PDA member, ISPE member, ECA member, PQRI member, senior aseptic GMP expert, has deep knowledge in aseptic process development and verification, drug development and registration, CTD document writing and review, regulatory audit, international certification, international registration , quality system construction and maintenance, as well as sterile inspection, environmental monitoring and other fields. In recent years, he has focused on the analysis of trends in the macro pharmaceutical field and the risk management of pharmaceutical enterprise mergers and acquisitions projects.
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