{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,24]],"date-time":"2026-07-24T06:53:40Z","timestamp":1784876020095,"version":"3.55.0"},"reference-count":39,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2023,6,8]],"date-time":"2023-06-08T00:00:00Z","timestamp":1686182400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Pharmacol."],"abstract":"<jats:p>Pharmacogenomics, which is defined as the study of changes in the properties of DNA and RNA associated with drug response, enables the prediction of the efficacy and adverse effects of drugs based on patients\u2019 specific genetic mutations. For the safe and effective use of drugs, it is important that pharmacogenomic information is easily accessible to clinical experts and patients. Therefore, we examined the pharmacogenomic information provided on drug labels in Korea, Europe, Japan, and the United States (US). The selection of drugs that include pharmacogenomic information was based on the drug list that includes genetic information from the Korea Ministry of Food and Drug Safety (MFDS) and US Food and Drug Administration (FDA) websites. Drug labels were retrieved from the sites of MFDS, FDA, European Medicines Agency, and Japanese Pharmaceuticals and Medical Devices Agency. Drugs were classified as per the Anatomical Therapeutic Chemical code, and the biomarkers, labeling sections, and necessity of genetic tests were determined. In total, 348 drugs were selected from 380 drugs with available pharmacogenomic information in Korea and the US after applying the inclusion and exclusion criteria. Of these drugs, 137, 324, 169, and 126 were with pharmacogenomics information in Korea, the US, Europe, and Japan, respectively. The most commonly represented drug class was antineoplastic and immunomodulating agents. Regarding the classification as per the mentioned biomarkers, the cytochrome P450 enzyme was the most frequently mentioned information, and the targeted anticancer drugs most commonly required genetic biomarker testing. The reasons for differences in drug labeling information based on country include differences in mutant alleles according to ethnicity, frequencies at which drug lists are updated, and pharmacogenomics-related guidelines. Clinical experts must continuously strive to identify and report mutations that can explain drug efficacy or side effects for safe drug use.<\/jats:p>","DOI":"10.3389\/fphar.2023.1205624","type":"journal-article","created":{"date-parts":[[2023,6,8]],"date-time":"2023-06-08T05:48:26Z","timestamp":1686203306000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":11,"title":["Comparison of pharmacogenomic information for drug approvals provided by the national regulatory agencies in Korea, Europe, Japan, and the United States"],"prefix":"10.3389","volume":"14","author":[{"given":"Mijin","family":"Lee","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ji Min","family":"Han","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jaeyeon","family":"Lee","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ju Young","family":"Oh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jung Sun","family":"Kim","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hye Sun","family":"Gwak","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kyung Hee","family":"Choi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2023,6,8]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"204","DOI":"10.2174\/1389201018666170103103619","article-title":"Ubiquitous pharmacogenomics (U-PGx): The time for implementation is now. An Horizon2020 program to drive pharmacogenomics into clinical practice","volume":"18","author":"Cecchin","year":"2017","journal-title":"Curr. Pharm. Biotechnol."},{"key":"B2","doi-asserted-by":"publisher","first-page":"751","DOI":"10.1016\/j.nbt.2012.02.001","article-title":"Overcoming regulatory and economic challenges facing pharmacogenomics","volume":"29","author":"Cohen","year":"2012","journal-title":"N. Biotechnol."},{"key":"B3","doi-asserted-by":"publisher","first-page":"793","DOI":"10.1056\/NEJMp1500523","article-title":"A new initiative on precision medicine","volume":"372","author":"Collins","year":"2015","journal-title":"N. Engl. J. Med."},{"key":"B4","first-page":"1","volume-title":"Guideline on key aspects for the use of pharmacogenomics in the pharmacovigilance of medicinal products","year":"2015"},{"key":"B5","unstructured":"Medicines2021"},{"key":"B6","unstructured":"Drugs2021"},{"key":"B7","first-page":"1","article-title":"Guidance for industry: Drug interaction studies\u2014study design, data analysis, implications for dosing, and labeling recommendations","volume-title":"Center for drug evaluation and research (CDER)","year":"2012"},{"key":"B8","unstructured":"Table of pharmacogenomic biomarkers in drug labeling2021"},{"key":"B9","volume-title":"Table of pharmacogenomic biomarkers in drug labeling","year":"2022"},{"key":"B10","doi-asserted-by":"publisher","first-page":"809","DOI":"10.1056\/NEJMoa1002011","article-title":"Inhibition of mutated, activated BRAF in metastatic melanoma","volume":"363","author":"Flaherty","year":"2010","journal-title":"N. Engl. J. Med."},{"key":"B11","doi-asserted-by":"publisher","first-page":"655","DOI":"10.1038\/clpt.2014.185","article-title":"Evidence required to demonstrate clinical utility of pharmacogenetic testing: The debate continues","volume":"96","author":"Gillis","year":"2014","journal-title":"Clin. Pharmacol. Ther."},{"key":"B12","doi-asserted-by":"publisher","first-page":"297","DOI":"10.1097\/01.fpc.0000199500.46842.4a","article-title":"Genetic susceptibility to carbamazepine-induced cutaneous adverse drug reactions","volume":"16","author":"Hung","year":"2006","journal-title":"Pharmacogenet Genomics"},{"key":"B13","doi-asserted-by":"publisher","first-page":"493","DOI":"10.1111\/jcpt.12691","article-title":"Pharmacogenomic information in the warning section of drug labels: A comparison between labels in the United States and those in five other countries\/regions","volume":"43","author":"Imatoh","year":"2018","journal-title":"J. Clin. Pharm. Ther."},{"key":"B14","doi-asserted-by":"publisher","first-page":"505","DOI":"10.1586\/17512433.1.4.505","article-title":"Current Japanese regulatory situations of pharmacogenomics in drug administration","volume":"1","author":"Ishiguro","year":"2008","journal-title":"Expert Rev. Clin. Pharmacol."},{"key":"B15","first-page":"3","article-title":"Approval of new pharmacogenomic tests: Is the Canadian regulatory process adequate?","volume":"8","author":"Joly","year":"2010","journal-title":"Can. J. Law Technol."},{"key":"B16","first-page":"20","article-title":"United States Food and drug administration product label changes","volume":"10","author":"Kircik","year":"2017","journal-title":"J. Clin. Aesthet. Dermatol"},{"key":"B17","doi-asserted-by":"publisher","first-page":"813","DOI":"10.1016\/j.drudis.2020.01.023","article-title":"Study of pharmacogenomic information in FDA-approved drug labeling to facilitate application of precision medicine","volume":"25","author":"Mehta","year":"2020","journal-title":"Drug Discov. Today"},{"key":"B18","volume-title":"Clinical pharmacogenomics; Guidelines for use and permission descriptions in initial clinical trials","year":"2015"},{"key":"B19","unstructured":"Drug information search2021"},{"key":"B20","volume-title":"Pharmacogenetic biomarker eligibility evaluation guidelines","year":""},{"key":"B21","volume-title":"Pharmacogenomic biomarker qualification guidelines","year":""},{"key":"B22","unstructured":"Pharmacogenomic information of Korean Ministry of Food and drug safety2021"},{"key":"B23","unstructured":"Companion diagnostics WG2022"},{"key":"B24","unstructured":"iyakuSearch2021"},{"key":"B25","volume-title":"Submission of information to regulatory authorities for preparation of guidance on the use of pharmacogenomics in clinical studies","year":"2005"},{"key":"B26","doi-asserted-by":"publisher","first-page":"343","DOI":"10.1038\/nature15817","article-title":"Pharmacogenomics in the clinic","volume":"526","author":"Relling","year":"2015","journal-title":"Nature"},{"key":"B27","doi-asserted-by":"publisher","first-page":"464","DOI":"10.1038\/clpt.2010.279","article-title":"CPIC: Clinical pharmacogenetics implementation Consortium of the pharmacogenomics research network","volume":"89","author":"Relling","year":"2011","journal-title":"Clin. Pharmacol. Ther."},{"key":"B28","doi-asserted-by":"publisher","first-page":"839","DOI":"10.1016\/j.ctrv.2013.05.001","article-title":"Epidermal growth factor receptor tyrosine kinase inhibitors as initial therapy for non-small cell lung cancer: Focus on epidermal growth factor receptor mutation testing and mutation-positive patients","volume":"39","author":"Roengvoraphoj","year":"2013","journal-title":"Cancer Treat. Rev."},{"key":"B29","doi-asserted-by":"publisher","first-page":"357","DOI":"10.36118\/pharmadvances.2021.03","article-title":"Cancer pharmacogenetics: Perspective on newly discovered and implemented predictive biomarkers","volume":"3","author":"Roncato","year":"2021","journal-title":"Pharmadvances"},{"key":"B30","doi-asserted-by":"publisher","first-page":"1240","DOI":"10.1002\/cpt.1720","article-title":"Evaluation of current regulation and guidelines of pharmacogenomic drug labels: Opportunities for improvements","volume":"107","author":"Shekhani","year":"2020","journal-title":"Clin. Pharmacol. Ther."},{"key":"B31","doi-asserted-by":"publisher","first-page":"662","DOI":"10.1038\/clpt.2011.34","article-title":"Pharmacogenetics: From bench to byte--an update of guidelines","volume":"89","author":"Swen","year":"2011","journal-title":"Clin. Pharmacol. Ther."},{"key":"B32","doi-asserted-by":"publisher","first-page":"2049","DOI":"10.1056\/NEJMoa042934","article-title":"Combination of isosorbide dinitrate and hydralazine in blacks with heart failure","volume":"351","author":"Taylor","year":"2004","journal-title":"N. Engl. J. Med."},{"key":"B33","doi-asserted-by":"publisher","first-page":"169","DOI":"10.3233\/WOR-2009-0863","article-title":"Drug labeling and its impact on patient safety","volume":"33","author":"Vredenburgh","year":"2009","journal-title":"Work"},{"key":"B34","unstructured":"ATC\/DDD index 20212021"},{"key":"B35","doi-asserted-by":"publisher","first-page":"1482","DOI":"10.1007\/s11606-016-3816-x","article-title":"A patient-centered prescription drug label to promote appropriate medication use and adherence","volume":"31","author":"Wolf","year":"2016","journal-title":"J. Gen. Intern Med."},{"key":"B36","doi-asserted-by":"publisher","first-page":"539","DOI":"10.1016\/S1470-2045(12)70086-4","article-title":"Afatinib for patients with lung adenocarcinoma and epidermal growth factor receptor mutations (LUX-Lung 2): A phase 2 trial","volume":"13","author":"Yang","year":"2012","journal-title":"Lancet Oncol."},{"key":"B37","doi-asserted-by":"publisher","first-page":"417","DOI":"10.1038\/clpt.2008.141","article-title":"The role of ethnicity in variability in response to drugs: Focus on clinical pharmacology studies","volume":"84","author":"Yasuda","year":"2008","journal-title":"Clin. Pharmacol. Ther."},{"key":"B38","doi-asserted-by":"publisher","first-page":"189","DOI":"10.12793\/tcp.2020.28.e18","article-title":"Pharmacogenomic information from CPIC and DPWG guidelines and its application on drug labels","volume":"28","author":"Yoon","year":"2020","journal-title":"Transl. Clin. Pharmacol."},{"key":"B39","doi-asserted-by":"publisher","first-page":"735","DOI":"10.1016\/S1470-2045(11)70184-X","article-title":"Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): A multicentre, open-label, randomised, phase 3 study","volume":"12","author":"Zhou","year":"2011","journal-title":"Lancet Oncol."}],"container-title":["Frontiers in Pharmacology"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fphar.2023.1205624\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,6,8]],"date-time":"2023-06-08T05:48:40Z","timestamp":1686203320000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fphar.2023.1205624\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,6,8]]},"references-count":39,"alternative-id":["10.3389\/fphar.2023.1205624"],"URL":"https:\/\/doi.org\/10.3389\/fphar.2023.1205624","relation":{},"ISSN":["1663-9812"],"issn-type":[{"value":"1663-9812","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,6,8]]},"article-number":"1205624"}}