Reflection on Drug Regulatory Globalization Trend from the Heparin Sodium Event

Abstract

Abstract: Objective To provide some suggestions to cope with the challenges of drug regulatory globalization. Methods The investigation to the reason of event inspection, communication, rehabilitation and the deep risk of supply chain were analyzed through reviewing measures that FDA and relevant parties had given to heparin sodium event. Results Drug regulatory globalization is essentially the globalization of raw materials, intermediate products and preparations supply chain. Conclusion FDA’s global drug regulation has provided referential experience to China, and China should comply with the trend of regulatory globalization and take active countermeasures to ensure the safety of the drug supply chain.

Key words: heparin sodium event, drug regulatory globalization , supply chain

CLC Number:

R951

TIAN De-long, HUANG Zhi-lu. Reflection on Drug Regulatory Globalization Trend from the Heparin Sodium Event [J]. Chinese Journal of Pharmacovigilance, 2016, 13(1): 42-46.

References

[1] Baxter U S. Safety Information: Heparin Sodium Injection -Background Information[EB/OL].(2008-04-29) [2014-10- 24].http://www.baxter.com/information/safety_information/heparin_background_information.html.
[2] FDA. Information on adverse event report and heparin [EB/OL].(2009-06-18) [2014-10-24].http://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm112669.htm.
[3] Testimony of Robert L. Parkinson Chief Executive Officer, Baxter International Before Subcommittee on Oversight and Investigations Committee on Energy and Commerce U.S. House of Representatives April [EB/OL].(2008-04-29)[2014-11-01].http://www.baxter.com/downloads/information/safety_information/heparin/RLP_opening_comments.pdf.
[4] FDA. Warning Letter: Changzhou SPL Company ,Ltd.[EB/OL].(2008-0 4-21) [2014-11-01].http://www.fda.gov/ Warning Letter sand Notice of Violation Letters to Pharmaceutical Companies/UCM054109.Pdf.
[5] 韩亮, Nicholas, Buhay, 等. 美国FDA 药品生产质量监管体系[J].中国新药杂志, 2012, 21(18): 2128-2136.
[6] Blossom D B, Kallen A J, Patel P R, et al Outbreak of Adverse Reactions Associated with Contaminated Heparin[J]. N Engl J Med,2008,359(25): 2674-2684.
[7] Guerrini M, Beccati D, Shriver Z, et al.Over sulfated chondroitin sulfate is a contaminant in heparin associated with adverse clinical events [J].Nature Biotechnology,2008,26:669-675.
[8] 刘璐, 杨悦. 透过肝素钠事件看美国FDA 对质量缺陷药品的风险管理[J]. 中国新药杂志, 2011, 20(20): 1941-1945.
[9] FDA. Advancing Health Through Public Standards-- USP & FDA’s Response to Heparin Crisis: A Timeline of Events [EB/OL] .(2014-03-26) [2015-02-01].http://www.usp.org/sites/default/files/usp_pdf/EN/valueOfStandards/heparinTimeline.pdf.
[10] FDA. Office of Global Regulatory Operations and Policy[EB/OL] .(2011-09-11)[2015-02-01].http://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/default.htm.
[11] FDA. FDA Globalization[EB/OL]. (2015-07-13)[2015-10-05].http://www.fda.gov/InternationalPrograms/FDABeyondOurBordersForeignOf fices/default.htm.
[12] FDA. Protecting Patients from Counterfeit and Other Substandard Drugs/Supply Chain Threats [EB/OL].(2012-12-04)[2015-03-05].http://www.fda.gov/downloads/forhealthprofessionals/ucm330640.pdf.
[13] FDA. Over view of Office of Pharmaceutical Quality (OPQ) [EB/OL].(2015-03-05) [2015-04-25].http://www.fda.gov/downloads/drugs/developmentapprovalprocess/smallbusinessassistance/ucm445608.pdf.
[14] FDA. PREDICT [EB/OL]. (2010-02-04) [2015-03-05].http://www.fdagov/newsevents/publichealthfocus/ucm199940.htm.
[15] FDA. Drug Supply Chain Security Act (DSCSA) [EB/OL]. (2013-11-27)[2015-03-10].http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/default.htm.
[16] Xiaoyuan Zheng, Shixia Zhang, Song Yang, et al. The impact of drug administration in USA, Europe and Japan on the reform plan in China [J].Journal of Chinese Pharmaceutical Sciences, 2014,23 (5): 324-329.