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EU legal and regulatory update May 2024 2024 年 5 月欧盟法律法规更新
Journal of generic medicines Pub Date : 2024-06-01 DOI: 10.1177/17411343241260142
{"title":"EU legal and regulatory update May 2024","authors":"","doi":"10.1177/17411343241260142","DOIUrl":"https://doi.org/10.1177/17411343241260142","url":null,"abstract":"","PeriodicalId":91117,"journal":{"name":"Journal of generic medicines","volume":"36 1","pages":"90 - 103"},"PeriodicalIF":0.0,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141399543","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Centers for medicare & medicaid services designate the first ten pharmaceuticals for negotiation under the medicare drug price negotiation program 医疗保险中心;根据医疗保险药品价格谈判计划，医疗补助服务指定前十种药品进行谈判
Journal of generic medicines Pub Date : 2023-11-07 DOI: 10.1177/17411343231209696
P. Branko Pejic
{"title":"Centers for medicare & medicaid services designate the first ten pharmaceuticals for negotiation under the medicare drug price negotiation program","authors":"P. Branko Pejic","doi":"10.1177/17411343231209696","DOIUrl":"https://doi.org/10.1177/17411343231209696","url":null,"abstract":"The Centers for Medicare & Medicaid Services has made the initial designation of 10 pharmaceuticals for negotiation under the Medicare Drug Price Negotiation Program, and the Industry has fired the first salvo of legal challenges to the constitutionality of the Program. This article provides an initial high level review of the Program and Industry challenges, which are not expected to be resolved until the cases work their way before the U.S. Supreme Court.","PeriodicalId":91117,"journal":{"name":"Journal of generic medicines","volume":"342 9","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135475037","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
EU legal and regulatory update September 2023 欧盟法律法规更新2023年9月
Journal of generic medicines Pub Date : 2023-11-06 DOI: 10.1177/17411343231213732
Richard Milchior
{"title":"EU legal and regulatory update September 2023","authors":"Richard Milchior","doi":"10.1177/17411343231213732","DOIUrl":"https://doi.org/10.1177/17411343231213732","url":null,"abstract":"Summary of case law concerning generic medicine from the EU or EU contries.","PeriodicalId":91117,"journal":{"name":"Journal of generic medicines","volume":"37 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135635470","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The journal of generic medicines – Editorial December 2023 仿制药杂志- 2023年12月社论
Journal of generic medicines Pub Date : 2023-10-30 DOI: 10.1177/17411343231213469
Brian Tempest
{"title":"The journal of generic medicines – Editorial December 2023","authors":"Brian Tempest","doi":"10.1177/17411343231213469","DOIUrl":"https://doi.org/10.1177/17411343231213469","url":null,"abstract":"","PeriodicalId":91117,"journal":{"name":"Journal of generic medicines","volume":"194 ","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136069110","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
An overview of regulatory perspectives of nanoparticles and liposomal products in India and USA 纳米颗粒和脂质体产品在印度和美国的监管观点概述
Journal of generic medicines Pub Date : 2023-10-16 DOI: 10.1177/17411343231206469
Rinshu Dabas, Pankaj Musyuni, Geeta Aggarwal
{"title":"An overview of regulatory perspectives of nanoparticles and liposomal products in India and USA","authors":"Rinshu Dabas, Pankaj Musyuni, Geeta Aggarwal","doi":"10.1177/17411343231206469","DOIUrl":"https://doi.org/10.1177/17411343231206469","url":null,"abstract":"Nanoparticles and Liposomal products have significantly contributed for managing various disorders and diseases. Drug delivery system is important and assisting in developing various therapeutic regimen. The present write-up discussed the role of novel drug delivery system, particularly applications of nanoparticles and liposomal products and regulatory requirement for these products. The article emphasises that there are enormous research opportunities and global collaboration is essential for promoting research and drug approval.","PeriodicalId":91117,"journal":{"name":"Journal of generic medicines","volume":"14 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136113564","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A comprehensive review addressing the factors influencing generic drug substitution 影响仿制药替代的因素综述
Journal of generic medicines Pub Date : 2023-10-06 DOI: 10.1177/17411343231206468
Fatima Jouni, Maribelle Mansour, Georges Hatem, Sanaa Awada
{"title":"A comprehensive review addressing the factors influencing generic drug substitution","authors":"Fatima Jouni, Maribelle Mansour, Georges Hatem, Sanaa Awada","doi":"10.1177/17411343231206468","DOIUrl":"https://doi.org/10.1177/17411343231206468","url":null,"abstract":"Generic drug substitution is a common practice in healthcare systems worldwide to promote cost-saving treatments while maintaining therapeutic effectiveness. Several factors influence this substitution, including regulatory policies, safety and efficacy considerations, patient and physician preferences, and market dynamics. This review comprehensively analyzes how these factors interact and influence generic drug substitution in healthcare settings and across various therapeutic classes and highlight the importance of balancing cost-saving measures with maintaining patient safety and therapeutic efficacy. Policies and guidelines established by health authorities in each country influence the approval, interchangeability, and substitution of generic drugs. Bioequivalence and therapeutic equivalence are critical factors, particularly in drugs with narrow therapeutic indexes. Moreover, physicians’ acceptance and willingness to prescribe generic drugs, as well as patient acceptance and compliance with generic drug use, play a vital role in promoting generic substitution.","PeriodicalId":91117,"journal":{"name":"Journal of generic medicines","volume":"35 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135350581","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Regulatory perspective of cancer drug development: An overview 癌症药物开发的监管视角:综述
Journal of generic medicines Pub Date : 2023-09-11 DOI: 10.1177/17411343231201064
Anurag Panchal, Pankaj Musyuni, Geeta Aggarwal
{"title":"Regulatory perspective of cancer drug development: An overview","authors":"Anurag Panchal, Pankaj Musyuni, Geeta Aggarwal","doi":"10.1177/17411343231201064","DOIUrl":"https://doi.org/10.1177/17411343231201064","url":null,"abstract":"Despite the fact postulated that better technology and scientific knowledge will lead to better medical services, the truth is very distinctive. Despite having the most cutting-edge scientific knowledge, America and the majority of Europe ironically have the maximum cancer rates. It shows that using technology and science alone to treat cancer and other diseases is inadequate. Additionally, it is now widely acknowledged that majority of pre-clinical tumour models are insufficient, because more than 95% of substances and molecules that kill cancerous cells in culture or reduce tumours in animals may fail in clinical studies in people. Additionally, the majority of anti-cancer medications which are authorised by regulatory bodies like the FDA have either no impact on survival of cancer patients or may raise by a few months. This is amidst the fact that majority of presently offered chemotherapeutic drugs are very expensive, leading to a lack of affordability.","PeriodicalId":91117,"journal":{"name":"Journal of generic medicines","volume":"57 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136024671","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
EU legal and regulatory update JULY 2023 欧盟法律法规更新2023年7月
Journal of generic medicines Pub Date : 2023-09-01 DOI: 10.1177/17411343231194155
Richard Milchior
{"title":"EU legal and regulatory update JULY 2023","authors":"Richard Milchior","doi":"10.1177/17411343231194155","DOIUrl":"https://doi.org/10.1177/17411343231194155","url":null,"abstract":"","PeriodicalId":91117,"journal":{"name":"Journal of generic medicines","volume":"132 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135347521","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Regulatory framework and disparities of complex generics in United States, European Union & Latin America 美国、欧盟复杂仿制药的监管框架与差异拉丁美洲
Journal of generic medicines Pub Date : 2023-09-01 DOI: 10.1177/17411343231194755
Mayank Bhatt, Sampann Tank, Jignesh Shah, Dilip Maheshwari
{"title":"Regulatory framework and disparities of complex generics in United States, European Union & Latin America","authors":"Mayank Bhatt, Sampann Tank, Jignesh Shah, Dilip Maheshwari","doi":"10.1177/17411343231194755","DOIUrl":"https://doi.org/10.1177/17411343231194755","url":null,"abstract":"The regulatory agencies all over the world have defined the pathway and the regulations for approval of simple small-molecule generics. In addition, the agencies are striving to form perspicuous regulatory frameworks for approval of biosimilar. According to this viewpoint, the approval of complex generics, also known as non-biological complex pharmaceuticals, is not subject to any clearly defined regulations (NBCDs). Although they differ from biologic products, complex medicines are constructed of huge, extremely complex, and synthetic components. The regulatory frameworks that are currently being used for complicated generics are opaque and uncertain. The market for complex generics is huge and there are fewer generic competitors in this area. In addition, the cost of bringing such generics into the market is high. Thus, there is a need for a well-defined pathway and guidance documents for the authorization of generic versions of complex drug products. The paper focus on the regulatory frameworks that the USA, EU, and Latin America have developed at this time to allow for the introduction of complicated generics to the market. In order to analyse regulatory policies in the USA, Europe, and Latin America for the marketing of NBCD copies, a case study of a product with an approved generic version is used. It also describes on the regulatory disparities existing among the three agencies in the light of complex generics.","PeriodicalId":91117,"journal":{"name":"Journal of generic medicines","volume":"3 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135347522","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The Journal of Generic Medicines – Editorial September 2023 仿制药杂志- 2023年9月社论
Journal of generic medicines Pub Date : 2023-08-09 DOI: 10.1177/17411343231195687
B. Tempest
{"title":"The Journal of Generic Medicines – Editorial September 2023","authors":"B. Tempest","doi":"10.1177/17411343231195687","DOIUrl":"https://doi.org/10.1177/17411343231195687","url":null,"abstract":"","PeriodicalId":91117,"journal":{"name":"Journal of generic medicines","volume":"1 1","pages":"119 - 119"},"PeriodicalIF":0.0,"publicationDate":"2023-08-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90823933","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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