Lifecycle Management of American Drug Labeling and Its Implication

Abstract

Abstract: Objective To put forward suggestions for improving drug labeling regulatory system and establishing a dynamic management system for drug labeling. Methods By studying American laws, regulations and guidelines of drug labeling, its scientific points were analyzed. Results and Conclusion It was suggested that we should learn the management pattern of America, improve the legal system of drug labeling in China, strengthen the classification management of labeling, set different labeling types based on different readers, improve the post-market drug labeling revision procedure. Generic drugs labeling should be consistent with new drugs labeling in principle. Penalties for drug labeling violation should be enhanced in order to promote the initiative of drug companies to revise labeling, accelerate the update of drug labeling, and finally form a dynamic adjustment mechanism throughout the drug lifecycle.

Key words: drug labeling, lifecycle management, regulatory system

CLC Number:

YU Jin-ran, WANG Hong-wei, WANG Yi-fang, YANG Yue. Lifecycle Management of American Drug Labeling and Its Implication[J]. Chinese Journal of Pharmacovigilance, 2018, 15(6): 333-338.

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URL: https://zgywjj.magtechjournal.com/EN/

https://zgywjj.magtechjournal.com/EN/Y2018/V15/I6/333

References

[1] 朱向珺,李瑛. 国内、外左炔诺孕酮紧急避孕药药品说明书的比较和分析[J]. 中国药房,2010,(9):842-844.
[2] 洪兰,朱俊怡. 国内外药品说明书和标签管理中有关警示语的比较研究[J].中国药房,2014,(33):3161-3164.
[3] 萧惠来. 中美两国氟喹诺酮类药品说明书更新的比较分析[J].药物评价研究,2016,39(6):919-924.
[4] FDA. OTC Drug and Prescription Drug [EB/OL].(2013-05-31)[2018-01-05]. https://www.accessdata.fda.gov/scripts/cder/training/otc/topic2/topic2/da_01_02_0070.htm.
[5] FDA.Labeling on Drugs@FDA vs.DailyMed[EB/OL].(2017-05-02)[2018-03-05] https://www.fda.gov/downloads/AboutFDA/WorkingatFDA/FellowshipInternshipGraduateFacultyPrograms/Pharmacy-StudentExperientialProgramCDER/UCM555924.pdf.
[6] FDA.Guidance for Industry Labeling for Human Prescription Drug and Biological Products-Implementing the PLR Content and Format Requirements[EB/OL].(2013-02)[2018-03-22]. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM075082.pdf.
[7] FDA. Patient Labeling[EB/OL].(2014-08-15)[2017-12-09].https://www.fda.gov/downloads/forpatients/about/ucm410170.pdf.
[8] FDA. Learn About Your Medicines[EB/OL].(2017-04-21)[2017-12-26].https://www.fda.gov/for patients/ucm412663.htm.
[9] FDA. Small Business Assistance:Frequently Asked Questions on the Regulatory Process of Over-the-Counter (OTC) Drugs [EB/OL].(2016-11-22) [2018-03-01]. https://www.fda.gov/Drugs/Development ApprovalProcess/SmallBusinessAssistance/ucm069917.htm.
[10] FDA. CDER 21st Century Review Process Desk Reference Guide[EB/OL].(2014-09-01)[2018-03-09].https://www.fda.gov/downloads/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/manualofpoliciesprocedures/ucm218757.pdf.
[11] FDA. What are over-the-counter (OTC) drugs and how are they approved?[EB/OL].(2017-04-25)[2018-02-26]. https://www.fda.gov/aboutfda/transparency/basics/ucm194951.htm.
[12] FDA. What Is the Approval Process for Generic Drugs?[EB/OL].(2017-08-31)[2018-02-21].https://www.fda.gov/Drugs/Resources ForYou/Consumers/BuyingUsingMedicineSafely/GenericDrugs/ucm506040.htm.
[13] FDA. Guidance for Industry Safety Labeling Changes-Implementation of Section 505(o)(4) of the FD&C Act [EB/OL].(2014-06-05)[2017-12-06]. https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm250783.pdf.
[14] 李名石,任瑜,杨悦.美国药品说明书管理研究[J].中国药物警戒,2014,11(12):739-742+745.
[15] FDA. Guidance for Industry Changes to an Approved NDA or ANDA[S/OL].(2014-11-10)[2017-12-29].https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm077097.pdf.
[16] FDA. Guidance for Industry Revising ANDA Labeling Following Revision of the RLD Labeling[EB/OL].(2014-07-07)[ 2017-12-
16].https://www.fda.gov/downloads/drugs/guidancecompliancer-egulatoryinformation/guidances/ucm072891.pdf.
[17] 李名石,杨悦.药品标识缺陷法律问题研究[J].中国药物警戒,2014,11(9):542-546.