On the amendments of China's provisions for drug registration

Drug Information Journal

Volumn 42, Issue 5, 2008, Pages 467-475

  Zhao, Naiqing ^a   Yao, Chen ^b   Chen, Jie ^c  

^a FUDAN UNIVERSITY   (China)

^b PEKING UNIVERSITY FIRST HOSPITAL   (China)

^c MERCK RESEARCH LABORATORIES   (United States)

Author keywords

China; Clinical trial; Drug registration; Generic drug; Import drug

Indexed keywords

GENERIC DRUG; NEW DRUG;

ARTICLE; CHINA; CLINICAL RESEARCH; DRUG APPROVAL; DRUG FORMULARY; DRUG INDUSTRY; DRUG LABELING; DRUG LEGISLATION; DRUG MANUFACTURE; LEGAL LIABILITY; NOMENCLATURE; PRIORITY JOURNAL; REGISTRATION;

EID: 53849146065     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150804200507     Document Type: Article

References (7)

1. The State Food and Drug Administration of China. Provisions for Drug Registration (Revised) (in Chinese). July 10, 2007 Available at: http://www.sfda.gov.cn/WS01/CL0053/24529.html.
2. The State Food and Drug Administration of China website: www.sfda.gov.cn.
3. Sidley Austin LLP Major Amendments Proposed to China Drug Registration Regulation. March 2007. Available at: http://www.sidley.com/ clientupdates/Detail.aspx?news=3123.
4. Yin HZ. Regulations and procedures for new drug evaluation and approval in China. Hum Gene Ther. 2006;17:970-974.
5. Chen F, Chen QG, Chen J, Hsu J. Current statistical requirements for pharmaceutical clinical trials in China. Drug Inf J. 2008;42:321-330.
6. Deng RL, Kaitin KI. The regulation and approval of new drugs in China. Drug Inf J. 2004;37:29-39.
7. Ding JH. Regulatory approval of clinical trials in China. Presentation at the APEC Conference, November 22-23, 2004, Seoul, South Korea.