Therapeutic Equivalence Evaluation Code under the Framework of American Orange Book

doi:10.19803/j.1672-8629.2021.09.04

Abstract

Abstract: Objective To outline the therapeutic equivalence evaluation code (TE) under the framework of American Orange Book in order to offer some tips on quality and efficacy consistency evaluations of generic drugs in China. Methods The composition, coding rules and significance of the code were studied based on the background of the Orange Book and therapeutic equivalence evaluations in the United States.Ways to improve therapeutic equivalence evaluations in China were proposed. Results and Conclusion The implementation of TE will be of great help to medical institutions, the public, and drug regulatory agencies. In China, it is both necessary and possible to mark TE in the Catalogue of China Approved Drug Products. China's drug regulatory agencies should base their decisions on the current therapeutic equivalence evaluations of drugs in China, learn from other countries, and formulate rules and procedures for TE in line with the realities in China.

Key words: Orange Book, therapeutic equivalence evaluations code, therapeutic equivalence evaluation, therapeutically equivalent products, Catalogue of China Approved Drug Products

CLC Number:

R954

LI Yiyun, LIAO Caiyun, WEN Baoshu. Therapeutic Equivalence Evaluation Code under the Framework of American Orange Book[J]. Chinese Journal of Pharmacovigilance, 2021, 18(9): 813-816.

References

[1] Rosen DL.A practical guide to drug product selection: getting to know the Food and Drug Administration's (FDA's) approved drug products list (Orange Book) with therapeutic equivalence evaluations[J]. Journal of Pharmacy Practice, 1995, 8(3): 115-120.
[2] Office of the Federal Register, National Archives and Records Administration. Federal register volume 44, issue 9 [EB/OL] .(1979-01-12) [2021-02-01]. https://www.govinfo.gov/content/pkg/FR-1979-01-12/pdf/FR-1979-01-12.pdf.
[3] Food And Drug Administration. Therapeutically equiva-lent drugs; avail-ability of list[J]. Federal Register, 1980, 45(213): 72582-72608.
[4] China Food & Drug Administration Magazine. Notes on the Kefauver-Harris Amendments[J]. China Food & Drug Administration Magazine(中国食品药品监管), 2018, 3: 66.
[5] FDA. Drug Efficacy Study Implementation (DESI)[EB/OL]. (2020-08-28)[2021-02-01].https://www.fda.gov/drugs/enforcement-activities-fda/drug-efficacy-study-implementation-desi.
[6] FDA. Division of medical sciences, national research council; drug efficacy study: final report to the commissioner of food and drugs- Food and Drug Administration(1969)[S].FDA: Federal Register.
[7] Renu C, Mary EK, Brenda JK.FDA policy on unapproved drug products: past, present, and future[J]. Annals of Pharmacotherapy, 2005, 39: 7-8.
[8] Office of the Federal Register, National Archives and Records Administration. Federal register volume 45, issue 213 [EB/OL] (1980-10-31) [2021-02-01]. https://www.govinfo.gov/content/pkg/FR-1980-10-31/pdf/FR-1980-10-31.pdf.
[9] FDA. Orange Book Preface[EB/OL]. (2021-01-21)[2021-02-01]. https://www.fda.gov/drugs/development-approval-process-drugs/orange-book-preface.
[10] Parker RE, Martinez DR, Covington TR.Drug product selection-part 3: the orange book[J]. American Pharmacy, 1991, NS31: 9.
[11] Zhou N, Zhao HJ, Liang Y.On perfecting the consistency evalu-ation system of generic drugs in China from the perspective of pharmaceutical enterprises[J]. Mechanical and Electrical Inform-ation(机电信息), 2018(32): 10-14.
[12] Opinions of the State Council on Reforming the Examination and Approval System of Drugs and Medical Devices[J]. Gazette of the State Council of the People's Republic of China(中华人民共和国国务院公报), 2015, 25: 22-25.
[13] National Medical Products Administration. Announcement of the State Drug Administration on Issuing the Catalogue of Listed Drugs in China[EB/OL]. (2017-12-28)[2021-02-01]. http://list.cde.org.cn/news/detail?id=5.
[14] The Catalogue of Listed Drugs in China. Guide for use[EB/OL]. (2017-12-29)[2021-02-01]. http://list.cde.org.cn/about/guide.