The regulation and approval of new drugs in China

Drug Information Journal

Volumn 38, Issue 1, 2004, Pages 29-39

  Deng, Rongling ^a   Kaitin, Kenneth I ^a  

^a TUFTS UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

China; Drug development; New chemical entity; Pharmaceutical industry; World Trade Organization

Indexed keywords

NEW DRUG;

CHINA; DRUG APPROVAL; DRUG INDUSTRY; DRUG LEGISLATION; DRUG MARKETING; HEALTH CARE POLICY; PRIORITY JOURNAL; REVIEW;

EID: 2942701772     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150403800105     Document Type: Review

References (14)

1. Kaitin KI, Healy EM. The new drug approvals of 1996, 1997, and 1998: drug development trends in the user fee era. Drug Inf J. 2000;34(1):1-14.
2. Drug Administrative Law. Beijing, China: National Law of the People's Republic of China; 1985.
3. Ministry of Health, China. Provisions for New Drug Approval. Beijing, China: Ministry of Health; 1985.
4. Ministry of Health, China. Provisions for New Biological Product Approval. Beijing, China: Ministry of Health; 1985.
5. Ministry of Health, China. Provisions for Importation Registration. Beijing, China: Ministry of Health; 1991.
6. State Drug Administration, China. Provisions for Importation Registration. Beijing, China: State Drug Administration: 1999.
7. State Pharmaceutical Administration of China. Provisions for Drug Administration Protection. Beijing, China: State Medical and Drug Administration Bureau; 1993.
8. State Drug Administration, China. Provisions for New Drug Approval. Beijing, China: State Drug Administration; 1999.
9. State Drug Administration, China. Drug Registration Procedure. Beijing, China: State Drug Administration; 2000.
10. Center for Drug Evaluation, China. National new drug registration database, 2001. www.cde.org.cn. Accessed May 2, 2002.
11. State Drug Administration. Administrative protection approvals: 1993-2000. www.sda.gov.cn. Accessed September 10, 2001.
12. Summary of the National Pharmaceutical Administration in 2001. Xinhua News Agency. big5.xinhuanet.com/gate/big5/news.xinhuanet. com/zhengfu/2002-02/ 07/content_272025.htm. Accessed May, 2, 2002.
13. US Department of Commerce, International Trade Administration. Pharmaceutical industry fact sheet: China. www.mac.doc.gov/China/Docs/ industryfactsheets/pharmaceuticals.html. Accessed May 24, 2002.
14. Hamrock S, Whiting, C, Blaha C, Clark H, Lashley D. Market access and compliance: what it means for U.S. industry. www.mac.doc.gov/China/Docs/ exportamerica/WTOChina.html. Accessed May 24, 2002.