Regulations and guidelines should be strengthened urgently for re-evaluation on post-marketing medicines in China

Chinese Journal of Integrative Medicine

Volumn 19, Issue 7, 2013, Pages 483-487

  Xie, Yan Ming ^a   Tian, Feng ^a  

^a INSTITUTE OF CHINESE MATERIA MEDICA   (China)

Author keywords

pharmacovigilance; post marketing medicines; re evaluation; regulations and guidelines

Indexed keywords

ADVERSE DRUG REACTION; CHINA; CHINESE MEDICINE; DEVELOPED COUNTRY; DRUG EFFICACY; DRUG INDUSTRY; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; HUMAN; POSTMARKETING SURVEILLANCE; PRACTICE GUIDELINE; PRIORITY JOURNAL; REVIEW; RISK MANAGEMENT;

CHINA; DEVELOPED COUNTRIES; DRUG AND NARCOTIC CONTROL; GUIDELINES AS TOPIC; PRODUCT SURVEILLANCE, POSTMARKETING;

EID: 84879914755     PISSN: 16720415     EISSN: 19930402     Source Type: Journal    
DOI: 10.1007/s11655-013-1500-0     Document Type: Review

References (29)

1. The World Health Organization. Pharmacovigilance: Ensuring the safe use of medicines, 2004. http://whqlibdoc.who.int/hq/2004/WHO-EDM-2004.8.pdf
2. The World Health Organization. The safety of medicines in public health programmes: pharmacovigilance - an essential tool, 2006. http://www.who.int/ medicines/areas/quality-safety/safety/Pharmacovigilance-B.pdf
3. The World Health Organization. The importance of pharmacovigilance: safety monitoring of medicinal products, 2002. http://apps.who.int/medicinedocs/ en/d/Js4893e/10.html
4. The World Health Organization. Safety monitoring of medicinal products: guidelines for setting up and running a pharmacovigilance centre, 2000. http://who-umc.org/DynPage.aspx?id=105828&mn1=7347&mn2=7259&mn3= 7297&mn4=7496
5. The World Health Organization. Safety of medicines: a guide to detecting and reporting adverse drug reactions, 2002. http://apps.who.int/medicinedocs/en/ d/Jh2992e/10.html
6. The World Health Organization. Guidelines on safety monitoring of herbal medicines in pharmacovigilance systems, 2004. http://apps.who.int/medicinedocs/ en/m/abstract/Js7148e/
7. The United States. Code of federal regulations, CFR part 21, chapter 314, 1985. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm? cfrpart=314
8. The United States. Federal food, drug, and cosmetic act, 2010. http://www.fda.gov/regulatoryinformation/legislation/ federalfooddrugandcosmeticactfdcact/default.htm
9. The Food and Drug Administration. Food and drug administration amendments act of 2007, 2007. http://www.fda.gov/regulatoryinformation/legislation/ federalfooddrugandcosmeticactfdcact/significantamendmentstothefdcact/ foodanddrugadministrationamendmentsactof2007/default.htm
10. The Food and Drug Administration. Post-marketing commitments study: final report, 2008. http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ UserFeeReports/Studies/ucm201183.htm
11. The Food and Drug Administration. MedWatch reporting forms, 2003. https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
12. The Food and Drug Administration. 21CFR7 subpart C-recalls (including product corrections)-guidance on policy, procedures and industry responsibilities, 2012. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ CFRSearch.cfm?CFRPart=7&showFR=1&subpartNode=21:1.0.1.1.5.3
13. The Food and Drug Administration. Guidance for industry product recalls, including removals and corrections, 2003. http://www.fda.gov/Safety/Recalls/ IndustryGuidance/ucm129259.htm
14. European Union. Regulation (EC) No 726/2004 of the European parliament and of the council of 31 March 2004: laying down community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European medicines agency, 2004. http://eur-lex.europa.eu/ LexUriServ/LexUriServ.do?uri=OJ:L:2004:136:0001:0033:en:PDF
15. European Union. Directive 2001/83/EC of the European parliament and of the council of 6 November 2001 on the community code relating to medicinal products for human use, 2001. http://ec.europa.eu/health/files/eudralex/vol-1/ dir-2001-83/2001-83-ec-en.pdf
16. European Union. Regulation (EU) No 1235/2010 of the European parliament and of the council of 15 December 2010, 2010.
17. European Union. Directive 2010/84/EU of the European parliament and of the council of 15 December 2010: amending, as regards pharmacovigilance, directive 2001/83/EC on the community code relating to medicinal products for human use, 2010. http://ec.europa.eu/health/files/eudralex/vol-1/dir-2010-84/ dir-2010-84-en.pdf
18. European Union. The commission implement ing regulation (EU) No 520/2012 on the performance of pharmacovigilance activities, 2012.
19. Good pharmacovigilance practices (GVP), 2012.
20. Japan Pharmaceutical Manufacturers Association. Pharmaceutical administration and regulations in Japan, 2012:138-139. http://www.jpma.or.jp/ english/parj/1203.htm
21. Drug Administration Law of the People's Republic of China, 2001. http://eng.sfda.gov.cn/WS03/CL0766/61638.htm
22. Regulations for Implementation of the Drug Administration Law of the People' s Republic of China, 2002. http://eng.sfda.gov.cn/WS03/CL0767/61640.htm
23. State Food and Drug Administration. Provisions for drug registration, 2007. http://eng.sfda.gov.cn/WS03/CL0768/61645.htm
24. State Food and Drug Administration. Provisions for drug insert sheets and labels, 2006. http://eng.sfda.gov.cn/WS03/CL0768/61647.htm
25. State Food and Drug Administration. Provisions for Drug recall, 2007.
26. Ministry of Health. Provisions for adverse drug reaction reporting and monitoring management, 2011.
27. State Food and Drug Administration. Supplementary provisions on Chinese medicine registration, 2008.
28. State Food and Drug Administration. Basic technical requirements for safety re-evaluation of traditional Chinese medicine injections (Draft), 2009.
29. State Food and Drug Administration. Guidelines for clinical techniques on safety re-evaluation of traditional Chinese medicine injections (Draft), 2010.