A Survey of Industry Perceptions of Facilitated Regulatory Pathways in Drug Development in Australia.

IF 3.1 Q2 PHARMACOLOGY & PHARMACY
Pharmaceutical Medicine Pub Date : 2023-09-01 Epub Date: 2023-06-27 DOI:10.1007/s40290-023-00483-x
Alina Yoffe, Johnson Liu, Greg Smith, Orin Chisholm
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引用次数: 0

Abstract

Background: In Australia, facilitated regulatory pathways (FRPs) became available with the introduction of priority review (PR) in 2017 and provisional approval (PA) in 2018, which aim to facilitate expedited review and approval for novel medicines. The pathways were developed in consultation with a wide range of stakeholders and have since been utilised by pharmaceutical companies for various therapeutic products. However, the perceptions of the firsthand users of these pathways have not been evaluated in Australia.

Objectives: We have conducted a survey of Australian regulatory professionals aiming to solicit the perceived benefits, barriers to utilisation, shortcomings and proposed modifications to utilising these pathways. We have also solicited the users' perspective on key aspects of the pathways, including overall satisfaction, regulatory burden, availability and ease of use of guidelines, regulator support, impact on company strategy and recommendations for improvement.

Methods: A survey was developed and distributed to Australian regulatory professionals from the pharmaceutical industry who had submission experience of new medicine applications via either PR, PA or the standard registration pathway to the Therapeutic Goods Administration (TGA). The questionnaire consisted of 44 questions with a skip logic and the option for free text comments.

Results: We received responses from 16/42 companies that had utilised these new pathways. Nine respondents had experience with the PR pathway and ten with the PA pathway. The respondents were generally satisfied with the effectiveness of the PR process in expediting registration approvals, but they were ambivalent towards the PA pathway in terms of overall satisfaction and timelines. Respondents expressed a desire for further improvements in the speed of approval, earlier access for patients across various pathways and introduction of new Health Technology Assessment processes for medicines approved under PA.

Conclusion: While the FRPs have been an important and positive development in the Australian regulatory landscape, there remain opportunities for further improvements, some of which have been highlighted by this study and may help inform future regulatory decisions.

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澳大利亚药品开发中促进监管途径的行业认知调查。
背景:在澳大利亚,随着2017年引入优先审评(PR)和2018年引入临时批准(PA),促进监管途径(FRPs)变得可用,旨在促进新药的快速审评和批准。这些途径是在与广泛的利益相关者协商后开发的,此后被制药公司用于各种治疗产品。然而,澳大利亚尚未对这些途径的第一手用户的看法进行评估。目的:我们对澳大利亚监管专业人员进行了一项调查,旨在了解利用这些途径的好处、障碍、缺点和拟议修改。我们还征求了用户对路径关键方面的看法,包括总体满意度、监管负担、指南的可用性和易用性、监管机构的支持、对公司战略的影响以及改进建议。方法:制定一项调查,并将其分发给澳大利亚制药行业的监管专业人员,他们通过PR、PA或标准注册途径向治疗用品管理局(TGA)提交新药申请。问卷由44个问题组成,带有跳过逻辑和自由文本评论选项。结果:我们收到了16/42家使用这些新途径的公司的回复。9名受访者有PR途径的经验,10名受访者有PA途径的经验。受访者普遍对PR流程在加快注册审批方面的有效性感到满意,但在总体满意度和时间表方面,他们对PA途径持矛盾态度。受访者表示希望进一步提高审批速度,让患者更早地通过各种途径获得批准,并为根据PA批准的药物引入新的健康技术评估流程。结论:尽管FRP在澳大利亚监管领域是一个重要而积极的发展,但仍有进一步改进的机会,其中一些已经在本研究中得到了强调,可能有助于为未来的监管决策提供信息。
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来源期刊
Pharmaceutical Medicine
Pharmaceutical Medicine PHARMACOLOGY & PHARMACY-
CiteScore
5.10
自引率
4.00%
发文量
36
期刊介绍: Pharmaceutical Medicine is a specialist discipline concerned with medical aspects of the discovery, development, evaluation, registration, regulation, monitoring, marketing, distribution and pricing of medicines, drug-device and drug-diagnostic combinations. The Journal disseminates information to support the community of professionals working in these highly inter-related functions. Key areas include translational medicine, clinical trial design, pharmacovigilance, clinical toxicology, drug regulation, clinical pharmacology, biostatistics and pharmacoeconomics. The Journal includes:Overviews of contentious or emerging issues.Comprehensive narrative reviews that provide an authoritative source of information on topical issues.Systematic reviews that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by PRISMA statement.Original research articles reporting the results of well-designed studies with a strong link to wider areas of clinical research.Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Pharmaceutical Medicine may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.All manuscripts are subject to peer review by international experts. Letters to the Editor are welcomed and will be considered for publication.
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