{"title":"药品紧急使用授权:历史与伦理困境。","authors":"Mamta Bishnoi, Aniket Sonker","doi":"10.4103/picr.picr_149_22","DOIUrl":null,"url":null,"abstract":"<p><p>The regulatory approval process of the United States Food and Drug Administration and European Union is the most demanding and challenging worldwide. They have the provision of the expedited approval pathways, i.e., \"Emergency use authorizations\" and \"Conditional marketing authorizations,\" respectively, to give approval to novel therapeutics agents during emergency situations. India, firstly formalized the accelerated pathway named \"Accelerated Approval Process\" as per the New Drugs and Clinical Trials rule 2019 to address unmet medical needs that was implemented by the Central Drug Standard Control Organization to approve the novel therapeutics agents during COVID-19. Hence, our aim is to understand and compare the different emergency approval processes in the world, their underlined claims and conditions with the list of approved products under this concept. All the information collected and analyzed from different official websites of regulatory bodies. In this review, we have enlightened on all these processes with their few approved products.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2023-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/23/b7/PCR-14-49.PMC10267997.pdf","citationCount":"2","resultStr":"{\"title\":\"Emergency use authorization of medicines: History and ethical dilemma.\",\"authors\":\"Mamta Bishnoi, Aniket Sonker\",\"doi\":\"10.4103/picr.picr_149_22\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>The regulatory approval process of the United States Food and Drug Administration and European Union is the most demanding and challenging worldwide. They have the provision of the expedited approval pathways, i.e., \\\"Emergency use authorizations\\\" and \\\"Conditional marketing authorizations,\\\" respectively, to give approval to novel therapeutics agents during emergency situations. India, firstly formalized the accelerated pathway named \\\"Accelerated Approval Process\\\" as per the New Drugs and Clinical Trials rule 2019 to address unmet medical needs that was implemented by the Central Drug Standard Control Organization to approve the novel therapeutics agents during COVID-19. Hence, our aim is to understand and compare the different emergency approval processes in the world, their underlined claims and conditions with the list of approved products under this concept. All the information collected and analyzed from different official websites of regulatory bodies. In this review, we have enlightened on all these processes with their few approved products.</p>\",\"PeriodicalId\":20015,\"journal\":{\"name\":\"Perspectives in Clinical Research\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2023-04-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/23/b7/PCR-14-49.PMC10267997.pdf\",\"citationCount\":\"2\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Perspectives in Clinical Research\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.4103/picr.picr_149_22\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2023/4/13 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Perspectives in Clinical Research","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.4103/picr.picr_149_22","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2023/4/13 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"Medicine","Score":null,"Total":0}
Emergency use authorization of medicines: History and ethical dilemma.
The regulatory approval process of the United States Food and Drug Administration and European Union is the most demanding and challenging worldwide. They have the provision of the expedited approval pathways, i.e., "Emergency use authorizations" and "Conditional marketing authorizations," respectively, to give approval to novel therapeutics agents during emergency situations. India, firstly formalized the accelerated pathway named "Accelerated Approval Process" as per the New Drugs and Clinical Trials rule 2019 to address unmet medical needs that was implemented by the Central Drug Standard Control Organization to approve the novel therapeutics agents during COVID-19. Hence, our aim is to understand and compare the different emergency approval processes in the world, their underlined claims and conditions with the list of approved products under this concept. All the information collected and analyzed from different official websites of regulatory bodies. In this review, we have enlightened on all these processes with their few approved products.
期刊介绍:
This peer review quarterly journal is positioned to build a learning clinical research community in India. This scientific journal will have a broad coverage of topics across clinical research disciplines including clinical research methodology, research ethics, clinical data management, training, data management, biostatistics, regulatory and will include original articles, reviews, news and views, perspectives, and other interesting sections. PICR will offer all clinical research stakeholders in India – academicians, ethics committees, regulators, and industry professionals -a forum for exchange of ideas, information and opinions.