Chinese Journal of Pharmacovigilance ›› 2023, Vol. 20 ›› Issue (8): 904-910.
DOI: 10.19803/j.1672-8629.20220444
Previous Articles Next Articles
ZHANG Yuqi1, XU Xinyi2, ZHU Lan3, ZHU Yan1,*
Received:
2022-07-27
Online:
2023-08-15
Published:
2023-08-07
CLC Number:
ZHANG Yuqi, XU Xinyi, ZHU Lan, ZHU Yan. Comparison standard terminology for pharmaceutical dose forms[J]. Chinese Journal of Pharmacovigilance, 2023, 20(8): 904-910.
[1] ICH. Press release: ICH assembly virtual meeting, June 2021[EB/OL]. (2021-06-10)[2022-04-13]. https://www.ich.org/pressrelease/press-release-ich-assembly-virtual-meeting-june-2021. [2] ICH. History[EB/OL]. (2021-10-29)[2022-06-14]. https://www.ich.org/page/history. [3] China Food and Drug Administration. CFDA announcement on the application of ICH secondary guidelines(No.10, 2018)[EB/OL]. (2018-01-25)[2023-02-05]. https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/ggtg/qtggtg/20180125175101686.html. [4] National Medical Products Administration. Annual report for national adverse drug reaction monitoring(2020)[EB/OL]. (2021-03-26)[2022-05-29]. https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/20210325170127199.html. [5] National Medical Products Administration. The technical guideline for the revision of specification safety information item of marketed traditional Chinese medicines(interim)[EB/OL]. (2022-01-04)[2022-07-14]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20220107145808154.html. [6] National Medical Products Administration. Guidelines for the collection and reporting of individual adverse drug reactions[EB/OL]. (2018-12-19)[2022-07-15]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20181221172901438.html. [7] WHO. ICD-11 reference guide[EB/OL]. (2022-09-29)[2023-02-05]. https://icdcdn.who.int/icd11referenceguide/en/html/index.html. [8] TIAN CH, LIU W, LIU CL, et al.Progress in implementation of ICH M1 in post-marketing monitoring of drugs in China[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2021, 18(8): 763-765. [9] FAN R, DONG D.Overview and thoughts on WHO international drug monitoring[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2021, 18(1): 43-46. [10] UMC. WHO-ART legacy service[EB/OL]. (2021-11-30)[2022-07-22]. https://who-umc.org/vigibase/vigibase-services/who-art/. [11] HOU YF, FANG KR, QI Y, et al.Thoughts on implementing E2B(R3) in individual case safety reports in China[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2019, 16(10): 588-590. [12] FANG L.Pharmaceutics(方剂学)[M]. Beijing: People's Medical Publishing House, 2016. [13] NIU ZX, XING YB, MA SL.Children's medication compliance and its influencing factors[J]. Journal of Pediatric Pharmacy(儿科药学杂志), 2022, 27(1): 31-34. [14] ZHAO YY, ZHANG CL, XIE YZ, et al.Clinical recommended dose for opioids in the treatment of cancer pain patient[J]. Herald of Medicine(医药导报), 2021, 40(2): 56-60. [15] UCHIDA T.Trade-offs in the development of various dosage form (overview)[J]. Yakugaku Zasshi, 2015, 135(2): 221-227. [16] GUI YL, YANG L, ZENG XT, et al.Methodology for clinical practice guidelines-economic evaluation evidence[J]. Chinese Journal of Evidence-Based Cardiovascular Medicine(中国循证心血管医学杂志), 2018, 10(11): 1285-1288. [17] ALJ L, BENKIRANE R, TEBAA A, et al.Construction and analysis of a database for medication errors in a pharmacovigilance centre-the Moroccan experience[J]. European Journal of Clinical Pharmacology, 2021, 77(8): 1235-1246. [18] GORE R, CHUGH PK, TRIPATHI CD, et al.Pediatric off-label and unlicensed drug use and its implications[J]. Current Clinical Pharmacology, 2017, 12(1): 18-25. [19] KADER R, LIMINGA G, LJUNGMAN G, et al.Manipulations of oral medications in paediatric neurology and oncology care at a Swedish university hospital: health professionals' attitudes and sources of information[J]. Pharmaceutics, 2021, 13(10): 1676. [20] EMA. Mandatory use of ISO ICSR/ICH E2B(R3) andEDQM terminology for Dosage Forms (DF) andRoutes of Administration (RoA)[EB/OL]. (2022-05-16)[2022-07-13]. https://www.ema.europa.eu/en/documents/other/mandatory-use-iso-icsr/ich-e2br3-edqm-terminology-dosage-forms-df-routes-administration-roa_en.pdf. [21] FDA. Electronic submission of adverse event reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) standards[EB/OL]. (2020-02-19)[2022-07-13]. https://www.fda.gov/drugs/news-events-human-drugs/electronic-submission-adverse-event-reports-fda-adverse-event-reporting-system-faers-using. [22] National Medical Products Administration. Announcement on issuing regional implementation guide for E2B(R3) individual case safety reports[EB/OL]. (2019-11-22)[2022-02-28]. https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjzh/20191122091301498.html. [23] NING BM, YAN J, ZHANG QM, et al.Introduction of guideline for establishment of European Pharmacopoeia reference standard[J]. Drug Standards of China(中国药品标准), 2006, 7(4): 74-79. [24] HOU YF, LIU HL, LI XL, et al.An overview of EU SPOR project[J].Chinese Journal of Pharmacovigilance(中国药物警戒), 2019, 16(12): 716-721. [25] Pharmaceuticals And Medical Device Agency. Japanese pharmacopoeia editions and supplements[S]. Tokyo: The Ministry of Health, Labour and Welfare, 2021. [26] National Medical Products Administration. NMPA issued opinions on facilitating the inheritance, innovation and development of Chinese materia medica[EB/OL]. (2020-12-21)[2022-06-23]. https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/20201225163906151.html. [27] Chinese Pharmacopoeia Commission.Pharmacopoeia of the People's Republic of China(中华人民共和国药典)[S]. Beijing: China Medical Science Press, 2020. [28] WHO. The use of essential drugs: ninth report of the WHO Expert Committee (including the revised model list of essential drugs)[EB/OL]. (2000-01-01)[2022-02-19]. https://apps.who.int/iris/bitstream/handle/10665/42373/WHO_TRS_895.pdf?sequence=1. [29] ZUO J, PARK C, KUNG J, et al.Traditional Chinese medicine “Pill”, an ancient dosage form with surprising modern pharmaceutical characteristics[J]. Pharmaceutical Research, 2021, 38(2): 199-211. [30] CHEN Y.Standardization for information of prepared Chinese medicine dosage forms[J]. Chinese Journal of Medical Library and Information Science(中华医学图书情报杂志), 2017, 26(11): 59. [31] LI QW, YE QF, LYU QZ, et al.The problems on the list and database of medicines for children and corresponding solutions[J]. Chinese Journal of Drug Evaluation(中国药物评价), 2021, 38(3): 259-264. [32] ZHU L, JIA C.Suggestion on dosage form on standardized description of traditional Chinese medicine pills[J]. Drug Standards of China(中国药品标准), 2012, 13(6): 409-410. [33] National Medical Products Administration. Annual report for national adverse drug reaction monitoring(2021)[EB/OL]. (2020-03-30)[2022-06-07]. https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/20220329161925106.html. [34] The China Food and Drug Administration. General consideration for the evaluation of drugs changing dosage form(oral solid preparations) in the consistency evaluation of generic drug quality and efficacy[EB/OL]. (2017-02-13)[2022-05-31]. https://www.nmpa.gov.cn/zhuanti/ypqxgg/ggzhcfg/20170217105901708.html. [35] EDQM. Standard terms introduction and guidance for use[EB/OL]. (2018-11-16)[2022-02-19]. https://www.edqm.eu/documents/52006/389906/standard_terms_introduction_and_guidance_for_use.pdf. [36] SASS J, BECKER K, LUDMANN D, et al.Intercoder reliability of mapping between pharmaceutical dose forms in the German medication plan and EDQM standard terms[J]. Studies in Health Technology and Informatics, 2018, 247: 845-849. [37] FDA. FDA regional implementation guide for E2B(R3) electronic transmission of individual case safety reports for drug and biological products[EB/OL]. (2022-04-28)[2022-07-13]. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-regional-implementation-guide-e2br3-electronic-transmission-individual-case-safety-reports-drug. [38] China Food and Drug Administration. Regulations on management of drug instructions and labels[EB/OL]. (2006-03-15)[2022-05-31]. http://www.gov.cn/ziliao/flfg/2006-03/16/content_228465.htm. [39] National Medical Products Administration. NMPA announcement on issuing Regulations on the Administration of Drug Annual Reports[EB/OL]. (2022-04-11)[2022-05-31]. https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/fgwj/gzwj/gzwjyp/20220412172455115.htm. [40] National Medical Products Administration. Announcement on the adoption of Drug Registration License, Notification of Approval Drug Re-registration, Notification of Approval Drug Supplementary Application(edition2020)[EB/OL]. (2022-04-11)[2022-05-31]. https://www.nmpa.gov.cn/zwfw/zwfwgggs/tzgg/20200701140601855.html. [41] LIAO CY, LI YY, YAO WB, et al.Dissemination processes of the Chinese Orange Book: an empirical study[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2021, 18(9): 810-812. [42] National People's Congress Standing Committee. Drug Administration Law of the People's Republic of China(中华人民共和国药品管理法)[M]. Beijing: China Democracy and Legal Publishing House, 2019. [43] SU N, XU T.Drug coding research and development in hospital[J]. Chinese Pharmaceutical Journal(中国药学杂志), 2014, 49(6): 523-526. [44] LIANG HY, CHEN L, DING CH, et al.Suggestions on grouping drugs based on dosage forms and others rules in bidding and purchasing of non-essential drugs[J]. Pharmaceutical and Clinical Research(药学与临床研究), 2014, 22(6): 485-491. [45] WANG Y.Research on sharing coordination and application of drug information in China[D]. Shenyang: Shenyang Pharmaceutical University, 2019. [46] LIU J, REN LJ.Assessment and discussion of mini-tablets developed as a new dosage form for paediatric use[J]. Pharmaceutical and Clinical Research(药学与临床研究), 2021, 29(5): 393-397. [47] JIANG H, PENG BX, MA QY, et al.Research on new formulations for intratympanic administration for inner ear diseases[J]. Chinese Journal of Otology(中华耳科学杂志), 2020, 18(2): 399-403. [48] SUN JD, ZHANG ZQ, HE SW, et al.Progress on novel pediatric oral solid dosage forms[J]. Journal of China Pharmaceutical University(中国药科大学学报), 2019, 50(6): 631-640. [49] United States Pharmacopeial Convention. Publication & Comment Schedule[EB/OL]. (2021-06-01)[2022-03-24]. https://www.uspnf.com/publication-comment-schedule. [50] EDQM. Publication schedule 10th edition[EB/OL]. (2019-07-01)[2022-03-24]. https://www.edqm.eu/sites/default/files/01_schedule_2019_portrait.pdf. |
[1] | CAI Haili, ZHANG Xiaomeng, LIU Yadi, CHEN Lijuan, WANG Yu, ZHANG Bing. Preventive Strategies for Anthracycline-Induced Cardiotoxicity Using Traditional Chinese Medicine via Ferroptosis Regulation [J]. Chinese Journal of Pharmacovigilance, 2025, 22(8): 876-882. |
[2] | LIANG Jie. 172 Cases of Adverse Drug Reactions Induced by Antineoplastic Drugs [J]. Chinese Journal of Pharmacovigilance, 2025, 22(8): 928-932. |
[3] | LEI Jianlin, WANG Na, WANG Wenzheng, WANG Yan. One Case of Phenytoin Intoxication Caused by Compound Phenytoin Sodium Ephedrine Hydrochloride and Theophylline Tablets [J]. Chinese Journal of Pharmacovigilance, 2025, 22(7): 819-822. |
[4] | SHEN Lu, LIU Cuili, WANG Yi, HAO Mingqiang, WANG Yali, ZHU Huijuan, WU Chen, YANG Yang. Precision Pharmacovigilance for Cell and Gene Therapy Products [J]. Chinese Journal of Pharmacovigilance, 2025, 22(6): 633-639. |
[5] | CAO Weiping, ZHANG Shichao, NI Xia, XIE Bing, WANG Xinzhi, XING Mengtao. Research Progress in Liver Injury Caused by Drugs Commonly Used during Pregnancy [J]. Chinese Journal of Pharmacovigilance, 2025, 22(5): 528-531. |
[6] | CHEN Siyuan, ZHANG Yan, FENG Xue, ZHANG Caijuan, WANG Dunfang, LIU Haifan, LIU Bin, ZHU Lin, LIU Jianyao, LI Tao, YANG Weipeng. Identification of Chemical Constituents and Determination of Multi-Component Content of Lianpo Drinking Water Decoction Based on LC-MS/MS Technology [J]. Chinese Journal of Pharmacovigilance, 2025, 22(5): 554-559. |
[7] | JIN Shaoming, NING Xiao. Uncertainty Evaluation for Determination of Ambroxol in Rat Plasma by UPLC-MS/MS Method [J]. Chinese Journal of Pharmacovigilance, 2025, 22(4): 381-385. |
[8] | WANG Jiaqing, WANG Qi, LIU Tongtong, ZHANG Dongjie, NING Xiao. Uncertainty Evaluation for the Determination of Tacrolimus Content in Human Whole Blood by UPLC-MS/MS Method [J]. Chinese Journal of Pharmacovigilance, 2025, 22(4): 386-390. |
[9] | YANG Jingqi, XU Baohai, ZHANG Jing, JIANG Yang, SHI Fang. Pharmacovigilance for Traditional Chinese Patent Medicines for Orthopedics [J]. Chinese Journal of Pharmacovigilance, 2025, 22(4): 436-441. |
[10] | YANG Xuyun, SUN Yang, TIAN Chunhua, HU Zengyao. A National Pharmacovigilance Management System in a New Era [J]. Chinese Journal of Pharmacovigilance, 2025, 22(3): 276-281. |
[11] | LIU Ying, XIONG Shunyu, XIONG Huiyu, CAI Fei, XU Mengdan, WANG Qing, REN Wei, XU Yan. Methods for Assessment of MAH Compliance with GVP [J]. Chinese Journal of Pharmacovigilance, 2025, 22(3): 282-285. |
[12] | ZHENG Changhui, MA Lina, HE Ting, GU Yuanyuan, ZHAO Wei, WANG Hongbin, NIU Yuanfei, FU Yao, CHEN Yanjun, CAO Junling. Quality Evaluation and Control of Bupleuri Radix Decoction Pieces Based on ‘Shape-Chemistry-Biology' Sequential Detection [J]. Chinese Journal of Pharmacovigilance, 2025, 22(2): 197-205. |
[13] | SUN Ximu, ZHOU Han, LI Yanming, GUO Peng, NIE Xiaolu. Signal Mining and Analysis of ICIs-Associated Thrombocytopenia Adverse Events Based on FAERS Database [J]. Chinese Journal of Pharmacovigilance, 2025, 22(1): 23-28. |
[14] | ZAN Ke, CAI Xisheng, WU Yun, WANG Zhao, WANG Dandan, LI Hailiang, JIN Hongyu. Six Active Ingredients in Medicinal and Non-Medicinal Parts of Farfarae Flos: a Comparative Study [J]. Chinese Journal of Pharmacovigilance, 2025, 22(1): 67-71. |
[15] | DAI Mengru, LI Chun, ZHANG Yongxin, LU Yu, CHENG Boyu, FENG Weihong. Study on Catalpol Determination in Rehmanniae Radix [J]. Chinese Journal of Pharmacovigilance, 2025, 22(1): 76-83. |
Viewed | ||||||
Full text |
|
|||||
Abstract |
|
|||||