[1] LAGERLUND O, STRESE S, FLADVAD M, et al.WHODrug: a Global, Validated and Updated Dictionary for Medicinal Information[J]. Therapeutic Innovation & Regulatory Science, 2020, 54(5): 1116-1122. [2] HELLING M, VENULET J.Drug Recording and Classification by the WHO Research Centre for International Monitoring of Adverse Reactions to Drugs[J]. Methods Inf Med, 1974, 13(3): 169-178. [3] VENULET J, HELLING-BORDA M.WHO's International Drug Monitoring-The Formative Years, 1968-1975: Preparatory, Pilot and Early Operational Phases[J]. Drug Saf, 2010, 33(7): e1-e23. [4] LINDQUIST M.VigiBase, the WHO Global ICSR Database System: Basic Facts[J]. Drug Information J, 2008, 42: 409-419. [5] HJELMSTRÖM P, BOWRING G, YUE QY, et al. Methods for Signal Management Using the Global Safety Database VigiBase[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2024, 21(7): 836-840. [6] BABRE D.Medical Coding in Clinical Trials[J]. Perspectives in Clinical Research, 2010(1): 29-32. [7] LU Z.Technical Challenges in Designing Post-Marketing eCRFs to Address Clinical Safety and Pharmacovigilance Needs[J]. Contemporary Clinical Trials, 2010, 31(1): 108-118. [8] NAIR GJ.Ensuring Quality in the Coding Process: a Key Differentiator for the Accurate Interpretation of Safety Data[J]. Perspect Clin Res, 2013, 4(3): 181-185. [9] FDA. Food and Drug Administration Data Standards Catalog v10.32 [EB/OL]. [2025-08-31]. https://www.fda.gov/industry/fda-resources-data-standards/study-data-standards-resources. [10] Pharmaceuticals and Medical Devices Agency. Data Standards Catalog[EB/OL]. (2024-03-29)[2025-08-31]. https://www.pmda.go.jp/english/review-services/reviews/0002.html. [11] BEJAN-ANGOULVANT T, GENET T, VRIGNAUD L, et al.Three Case Reports of Involuntary Muscular Movements as Adverse Reactions to Sacubitril/Valsartan[J]. Brit J Clinical Pharma, 2018, 84(5): 1072-1074. [12] JUHLIN K, KARIMI G, ANDÉR M, et al. Using VigiBase to Identify Substandard Medicines: Detection Capacity and Key Prerequisites[J]. Drug Saf, 2015, 38(4): 373-382. [13] VAN STEKELENBORG J, ELLENIUS J, MASKELL S, et al.Recommendations for the Use of Social Media in Pharmacovigilance: Lessons from IMI WEB-RADR[J]. Drug Saf, 2019, 42(12): 1393-1407. [14] ELLENIUS JBT, DASGUPTA N, HEDFORS S, et al.Medication Name Entity Recognition in Tweets Using Global Dictionary Lookup and Word Sense Disambiguation[J]. Pharmacoepidemiol Drug Saf, 2016, 25(S3): 414-415. [15] STAR K, SANDBERG L, BERGVALL T, et al.Paediatric Safety Signals Identified in VigiBase: Methods and Results from Uppsala Monitoring Centre[J]. Pharmacoepidemiol Drug Saf, 2019, 28(5): 680-689. [16] WAKAO R, TAAVOLA H, SANDBERG L, et al.Data-Driven Identification of Adverse Event Reporting Patterns for Japan in VigiBase, the WHO Global Database of Individual Case Safety Reports[J]. Drug Saf, 2019, 42(12): 1487-1498. [17] Federal Commission for Protection against Sanitary Risks. Comunicado Del Centro Nacional De Farmacovigilancia a La Industria Farmacéutica[EB/OL].[2025-08-31].https://www.gob.mx/cofepris/acciones-y-programas/comunicado-del-centro-nacional-de-farmacovigilancia-a-la-industria-farmaceutica-322438?state=published. [18] Argentina's National Administration of Medicines, Food,Medical Technology. Administración Nacional de Medicamentos, Alimentos y Tecnología Médica[EB/OL]. (2024-04-05)[2025-08-31]. https://www.boletinoficial.gob.ar/detalleAviso/primera/305418/20240405. [19] Colombia's National Institute of Food and Drug Surveillance. República De Colombia Diario Oficial[EB/OL]. (2024-04-18)[2025-08-31]. https://svrpubindc.imprenta.gov.co/diario/view/diarioficial/consultarDiarios.xhtml. [20] Code of Federal Regulations. eCFR, Title 21, §314:3 Definitions [EB/OL].[2025-08-31]. https://www.ecfr.gov/. [21] WHO Collaborating Centre for Drug Statistics Methodology. Guidelines for ATC Classification and DDD Assignment[EB/OL].[2025-08-31]. https://atcddd.fhi.no/. [22] WATSON S, HÄRMARK L. Desogestrel and Panic Attacks-a New Suspected Adverse Drug Reaction Reported by Patients and Health Care Professionals on Spontaneous Reports[J]. Br J Clin Pharmacol, 2018, 84(8): 1858-1859. [23] BAERMANN H, FRISCHMANN M.Drug Groupings and Workflow Options for the Processing and Review of Concomitant Medication Data[EB/OL]. [2025-08-31].https://www.lexjansen.com/phuse/2013/dh/DH01.pdf. [24] REBECCA E, CHANDLER OL.The Utilisation of a New Tool in Signal Management—WHODrug Standardised Drug Groupings[M]. Philadelphia: ICPE, 2019. [25] Ministerio de Salud Pública. Ordenanza N°23/025 Actualización de la Ordenanza 798/014 que crea el Sistema Nacional de Farmaco-vigilancia[EB/OL]. (2025-01-13)[2025-08-31]. https://www.gub.uy/ministerio-salud-publica/institucional/normativa/ordenanza-n-23025-actualizacion-ordenanza-798014-crea-sistema-nacional. [26] Gaceta Oficial Digital. República De Panamá Ministerio De Salud [EB/OL]. (2024-05-10)[2025-08-31]. http://www.gacetaoficial.gob.pa/pdfTemp/30028_C/104722.pdf. [27] Órgãos do Governo. WHODrug Passa a Ser Obrigatório Para as Empresas Notificarem Eventos Adversos de Medicamentos[EB/OL].(2025-03-21)[2025-08-31]. https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2025/whodrug-passa-a-ser-obrigatorio-para-as-empresas-notificarem-eventos-adversos-de-medicamentos. [28] Korean Ministry of Food and Drug Safety. Korean Ministry of Food and Drug Safety[EB/OL].[2025-08-31]. https://nedrug.mfds.go.kr/bbs/34/39/. [29] European Medicines Agency.Guidance Documents Related to Data Submission for Authorised Medicines[EB/OL]. [2025-08-31].https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/reporting-requirements-marketing-authorisation-holders/guidance-documents-related-data-submission-authorised-medicines#outlines-on-article-57(2)-of-regulation-(eu)-726/2004-section. [30] MELDAU EL, BISTA S, ROFORS E, et al.Automated Drug Coding Using Artificial Intelligence: an Evaluation of WHODrug Koda on Adverse Event Reports[J]. Drug Saf, 2022, 45(5): 549-561. |