Innovative industry perspective: Assessing the proposed regulatory changes and their impact on innovation and competitiveness of the EU regulatory framework as part of the EU General Pharmaceutical Legislation revision

IF 7.5 2区医学 Q1 PHARMACOLOGY & PHARMACY

Drug Discovery Today Pub Date : 2025-09-09 DOI:10.1016/j.drudis.2025.104468

Sini M. Eskola , Nick Sykes , Sabine Atzor , Gloria Garcia-Palacios , Janina Dzambazoska , Álmath Spooner , Max Rex , Becky Neil , Magda Chlebus , Marie L. De Bruin , Helga Gardarsdottir , Emilie Neez

{"title":"Innovative industry perspective: Assessing the proposed regulatory changes and their impact on innovation and competitiveness of the EU regulatory framework as part of the EU General Pharmaceutical Legislation revision","authors":"Sini M. Eskola , Nick Sykes , Sabine Atzor , Gloria Garcia-Palacios , Janina Dzambazoska , Álmath Spooner , Max Rex , Becky Neil , Magda Chlebus , Marie L. De Bruin , Helga Gardarsdottir , Emilie Neez","doi":"10.1016/j.drudis.2025.104468","DOIUrl":null,"url":null,"abstract":"<div><div>This study is the innovative pharmaceutical industry’s assessment on the European Union (EU) General Pharmaceutical Legislation and proposed legislative revisions analysed across seven domains: robustness, patient centricity, predictability, speed, agility, efficiency, and innovator support. Based on interviews, workshops, and literature reviews, the current system is robust, predictable, and patient-centred but lacks agility, efficiency, and speed. The analysed changes included the Regulatory Sandbox, scientific support for combination products, diversification of evidence, and marketing authorisation holder (MAH) involvement in labelling decisions. A Regulatory Sandbox enhances the agility, speed, and innovation of the system. Three concerns weaken the effectiveness of the system: the complexity of providing scientific support for combination products, a lack of flexibility in utilising diverse types of evidence, and the exclusion of MAHs from labelling decisions. Policymakers must address these gaps to achieve a competitive legal framework.</div></div>","PeriodicalId":301,"journal":{"name":"Drug Discovery Today","volume":"30 10","pages":"Article 104468"},"PeriodicalIF":7.5000,"publicationDate":"2025-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Drug Discovery Today","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1359644625001813","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}

引用次数: 0

Abstract

This study is the innovative pharmaceutical industry’s assessment on the European Union (EU) General Pharmaceutical Legislation and proposed legislative revisions analysed across seven domains: robustness, patient centricity, predictability, speed, agility, efficiency, and innovator support. Based on interviews, workshops, and literature reviews, the current system is robust, predictable, and patient-centred but lacks agility, efficiency, and speed. The analysed changes included the Regulatory Sandbox, scientific support for combination products, diversification of evidence, and marketing authorisation holder (MAH) involvement in labelling decisions. A Regulatory Sandbox enhances the agility, speed, and innovation of the system. Three concerns weaken the effectiveness of the system: the complexity of providing scientific support for combination products, a lack of flexibility in utilising diverse types of evidence, and the exclusion of MAHs from labelling decisions. Policymakers must address these gaps to achieve a competitive legal framework.

查看原文本刊更多论文

创新行业视角：评估拟议的监管变化及其对欧盟监管框架的创新和竞争力的影响，作为欧盟一般药品立法修订的一部分。

本研究是创新制药行业对欧盟（EU）一般药品立法和拟议立法修订的评估，分析了七个领域：稳健性、以患者为中心、可预测性、速度、敏捷性、效率和创新者支持。根据访谈、研讨会和文献综述，目前的系统是稳健的、可预测的、以患者为中心的，但缺乏灵活性、效率和速度。分析的变化包括监管沙盒、组合产品的科学支持、证据的多样化以及上市许可持有人（MAH）参与标签决策。监管沙盒增强了系统的敏捷性、速度和创新性。三个问题削弱了该系统的有效性：为组合产品提供科学支持的复杂性，在利用不同类型证据方面缺乏灵活性，以及在标签决策中排除mah。政策制定者必须解决这些差距，以实现具有竞争力的法律框架。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Drug Discovery Today 医学-药学

CiteScore

14.80

自引率

2.70%

发文量

293

审稿时长

6 months

期刊介绍： Drug Discovery Today delivers informed and highly current reviews for the discovery community. The magazine addresses not only the rapid scientific developments in drug discovery associated technologies but also the management, commercial and regulatory issues that increasingly play a part in how R&D is planned, structured and executed. Features include comment by international experts, news and analysis of important developments, reviews of key scientific and strategic issues, overviews of recent progress in specific therapeutic areas and conference reports.