Comparison standard terminology for pharmaceutical dose forms

doi:10.19803/j.1672-8629.20220444

Abstract

Abstract: Objective To provide reference for standardization and internationalization of pharmaceutical dose forms of pharmacovigilance in China. Methods The conceptual model, classification system, characteristics of terms, and expanded applications of pharmaceutical dose forms in European Directorate for the Quality of Medicines (EDQM) standard terms were analyzed and compared with dosage forms in the Chinese Pharmacopoeia 2020 Edition. Based on the current applications of terms of dose forms in China, proposals were raised. Results Pharmaceutical dose forms are part of EDQM standard terms, which are an online semi-structured database maintained by European Directorate for the Quality of Medicines. Pharmaceutical dose forms in EDQM are accepted as preferred terms by ICH, and recognized worldwide. China National Medical Products Administration has supported their use in individual case safety reports as well. EDQM terminologies for dose forms are constructed on the basis of IDMP developed by ISO, especially the core conceptual model. There is a unique code, a definition, and 4 characteristics for each term, so that its meaning remains the same across languages and regions. Using taxonomy terms, a 3-level classification system and several auxiliary classifications are constructed, where terminologies for dose forms are at the third level. Dosage forms also play a role in complex concept modeling, such as combined pharmaceutical dose forms. Another reference for pharmaceutical dose forms of pharmacovigilance is Chinese Pharmacopoeia(CP) in China. It constructs a 3-level classification system for dose forms as well, but without taxonomy terms. Terminologies in it can be partially mapped to EDQM. There are differences in applications, accreditation criteria, and coverage between dose forms from Chinese Pharmacopoeia and EDQM. Inaccurate labelling of dose forms, and variations in terminologies, codes and classifications exist in the applications of dose forms of CP. Conclusion There is a need to improve Chinese translation of EDQM pharmaceutical dose forms so as to use them in combination with CP. China could consider completing terminologies for dose forms in CP, promoting standardization, and including new dose forms with reference to EDQM's experience.

Key words: pharmacovigilance, dosage form, term, European Directorate for the Quality of Medicines(EDQM), Chinese Pharmacopoeia, classification, schema, semi-structured

CLC Number:

R954
R994.11

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.

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