Pharmacovigilance in China: Current Situation, Successes and Challenges

Drug Safety

Volumn 37, Issue 10, 2014, Pages 765-770

  Zhang, Li ^a   Wong, Lisa Y L ^b   He, Ying ^b   Wong, Ian C K ^b  

^a Key lab of biological evaluation of medical devices of Shandong province   (China)

^b UNIVERSITY OF HONG KONG   (Hong Kong)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CHINA; CHINESE MEDICINE; DRUG INDUSTRY; DRUG SURVEILLANCE PROGRAM; HEALTH CARE SYSTEM; HUMAN; INFORMATION DISSEMINATION; INTERPERSONAL COMMUNICATION; PRIORITY JOURNAL; SIGNAL DETECTION; TRAINING; DRUG CONTROL; LEGISLATION AND JURISPRUDENCE; ORGANIZATION AND MANAGEMENT; POSTMARKETING SURVEILLANCE; RISK MANAGEMENT;

ADVERSE DRUG REACTION REPORTING SYSTEMS; CHINA; DRUG AND NARCOTIC CONTROL; HUMANS; PHARMACOVIGILANCE; PRODUCT SURVEILLANCE, POSTMARKETING; RISK MANAGEMENT;

EID: 84921343812     PISSN: 01145916     EISSN: 11791942     Source Type: Journal    
DOI: 10.1007/s40264-014-0222-3     Document Type: Article

References (13)

1. National Bureau of Statistics of the People’s Republic of China, China Statistical Yearbook 2013. http://www.stats.gov.cn/tjsj/ndsj/2013/indexeh.htm. Accessed 21 Aug 2014.
2. Information Office of the State Council, The People’s Republic of China. Medical and health services in China (December 2012). http://www.china-embassy.org/eng/zt/bps/t1001641.htm. Accessed 14 Aug 2014.
3. Sun XZ. Take scientific and steady step to promote complete coverage of drug electronic supervision in China. Chin J Pharm Guide. 2012;12(3):369–71.
4. Zhang L, Yan J, Liu X, Ye Z, Yang X, Meyboom R, et al. Pharmacovigilance practice and risk control of traditional Chinese medicine drugs in China: current status and future perspective. J Ethnopharm. 2012;140(3):519–25.
5. CFDA Releases 2013 Annual Report for National ADR Monitoring. China Food and Drug Newsletter. 2014;5:2–5. http://www.ccpie.org/news/download/2014pharm-5.pdf. Accessed 4 Sept 2014.
6. China Food and Drug Administration. Annual ADR report on national ADR monitoring, May 2014. http://www.sda.gov.cn/WS01/CL0078/99794.html. Accessed 4 Sept 2014.
7. Ministry of Health and China Food and Drug Administration, Adverse drug reaction reporting and monitoring provision, May 2011. http://www.sfda.gov.cn/WS01/CL0053/62621.html. Accessed 21 Aug 2014.
8. Zhang L, Yang XH, Cao LY, et al. Pondering on current status and development of monitoring on adverse reaction of traditional Chinese medicine in China. Chin J Integr Tradit West Med. 2005;25(7):581–4.
9. Chen F, Liu S, Wu J. Puerarin-induced immune hemolytic anemia. Int J Hematol. 2013;98(1):112–3.
10. Lin BL, Zhao ZX, Chong YT, Li JG, Zuo X, Tao Y, et al. Venous diethylene glycol poisoning in patients with preexisting severe liver disease in China. World J Gastroenterol. 2008;14(20):3236–41.
11. The International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH). ICH Harmonised tripartite guideline pharmacovigilance planning E2E (18 Nov 2004). http://www.ich.org/products/guidelines/efficacy/efficacy%20single/article/pharmacovigilance-planning.html. Accessed 21 Aug 2014.
12. European Medicines Agency, Good pharmacovigilance practices. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000345.jsp. Accessed 21 Aug 2014.
13. International Society for Pharmacoepidemiology. Guidelines for good pharmacoepidemiology practices (GPP) (Apr 2007). https://www.pharmacoepi.org/resources/guidelines_08027.cfm. Accessed 21 Aug 2014.