Abstract：OBJECTIVE To give advices on the reform of China′s modified new drug policy and implement the design of chemical drug registration classification. METHODS This paper provides an overview of the 505(b)(2) regulatory pathway with a focus on how modified new drug applications can be submitted. This paper also analyzes the key characteristics among the innovative drug, modified new drug and generic drug registration. This paper compares these key points with China′s new drug registration system and proposes the road to reform. RESULTS The policy promotes the R&D of the modified new drugs and the development of the pharmaceutical industry. Sponsors can use existing public data in lieu of conducting studies and focus on product innovation. Features are quite different among these three applications in the registration system. The property rights of the modified products are clearly defined. CONCLUSION It′s necessary for China to legislate regulations of modified new drug. The policy is positioned to promote clinical improvement, reduces duplication of research and improves property rights protection.
陶田甜, 邵蓉. 美国505(b)(2)路径对我国改良型新药政策改革的启示[J]. 中国药学杂志, 2019, 54(16): 1355-1360.
TAO Tian-tian, SHAO Rong. The Enlightenment of US 505(b)(2) Application to Modified New Drug Policy. Chinese Pharmaceutical Journal, 2019, 54(16): 1355-1360.
Food and Drug Administration.Abbreviated New Drug Applications and 505(b)(2) Applications (Final Rule). . FDA, 2016, 9: 4-12 . https://www.fda.gov/about-fda/economic-impact-analyses-fda-regulations/abbreviated-new-drug-applications-and-505b2-applications-final-rule.
[2]
Center for Drug Evaluation and Research.Guidance for Industry Applications Covered by Section 505(b)(2). . FDA, 1999, 10: 1-15. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applications-covered-section-505b2.
[3]
SALMINEN W F, WILES M E, STEVENS R E. Streamlining nonclinical drug development using the FDA 505(b)(2) new drug application regulatory pathway. Drug Discovery Today, 2019,24(1):46-56.
[4]
Center for Drug Evaluation and Research.Draft Guidance for Industry:Determining Whether to Submit an ANDA or 505(b)(2) Application. FDA, 2017, 10:13-16 . https://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm579802.htm.
[5]
WEINBERG S. Guidebook for Drug Regulatory Submissions. New Jersey:Wiley & Sons, 2009:183-254.
[6]
SHEETAL A, WEI Q, CHANDRAHAS S. Overview of recently approved 505(b)(2) new drug applications (2010-2012):role of clinical pharmacology. J Clin Pharmacol, 2014,54(12):1330-1336.
[7]
NAGARAJU P, GOWTHAMI K, LAKSHMI T, et al. A regulatory perspective of 505 (b) (2) new drug application. Inter J Pharm Chem Biol S, 2015,5(1):129.
[8]
BARRATT M J, FRAIL D E. Drug Repositioning:Bringing New Life to Shelved Assets and Existing Drugs. New Jersey:Wiley & Sons, 2012:65-88.
[9]
CFR-Code of Federal Regulations Title 21CFR314.54. CFR, 2019, 6:1290 . https://www. accessdata. fda. gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch. cfm?fr=314. 54.
[10]
CFR-Code of Federal Regulations Title 21CFR314.50. CFR, 2019, 6:1289 . https://www. accessdata. fda. gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch. cfm?fr=314. 50.
[11]
Food and Drug Administration. Abbreviated New Drug Applications and 505(b)(2) Applications. FDA, 2011, 8:2-7 . https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses / ucm 524628.htm.
[12]
SHUHONG Y, JINLI Z. The Legal Framework for Drug Regulation in the United States:The FDA′s Perspective(百年FDA美国药品监管法律框架) . Beijing:China Medical Science and Technology Press, 2008:904-915.
[13]
Center for Drug Evaluation and Research.Cambia (Diclofenac) Powder for Oral Solution-. FDA, 2008, 10:5-20 . https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022165s000TOC.cfm.
[14]
Center for Drug Evaluation and Research. CHOLBAM (cholic acid) Capsules. FDA, 2015, 3:8-13 . https://www. accessdata. fda. gov/drugsatfda_docs/nda/2015/205750Orig1s000TOC. cfm.
[15]
Center for Drug Evaluation and Research.Bendeka (bendamustine hydrochloride) Injection. FDA, 2015, 2:11-26 . https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208194Orig1s000TOC.cfm.
[16]
Center for Drug Evaluation and Research. Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) Inhalation Aerosol. FDA, 2015, 6:5-10 . https://www. accessdata. fda. gov/drugsatfda_docs/nda/2016/208294Orig1s000TOC. cfm.
[17]
XUE-DONG D, TAO S, FANG-HUA H, et al. General considerations and issues of special concern about the nonclinical study of modified new drugs. Chin J New Drugs(中国新药杂志), 2017, 26(18):2121-2127.
[18]
YANG Y, JIN Z, AI-PING Z, et al. Characteristics and future development of modified new drugs in China. J Int Pharm Res(国际药学研究杂志), 2017,44(6):522-526.
2019, Vol. 54 
