评估基于风险的药品注册方法:非洲监管当局的现状。

IF 3.1 Q2 PHARMACOLOGY & PHARMACY Pharmaceutical Medicine Pub Date : 2023-05-01 DOI:10.1007/s40290-023-00472-0
Neil McAuslane, Magda Bujar, Tariro Sithole, Nancy Ngum, Mercy Owusu-Asante, Stuart Walker
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引用次数: 0

摘要

背景:尽管全世界都需要增加获得安全有效药物的机会,但许多低收入和中等收入国家缺乏创新药物。在非洲大陆,这在一定程度上是由于国家监管机构(NRAs)的能力限制。解决这一问题的一个重要方法是工作共享和监管依赖。因此,这项关于非洲大陆管理当局的研究的目的是确定正在使用哪些基于风险的方法以及它们在未来可预见的作用。方法:本研究采用问卷调查的方式来确定哪些基于风险的模型用于药品的监管审批,确定哪些框架能够实现基于风险的方法,并为基于风险的模型的未来发展方向提供见解。调查表以电子方式发送给非洲大陆的26个国家登记机构。结果:21家机构(80%)完成了问卷调查。工作共享是最常用的模式,紧随其后的是单边依赖、信息共享和协作审查。这些方法被认为是有效和高效地利用资源,使患者能够更快地获得药物。当局的单边依赖方法包括对一系列产品的精简(85%)、验证(70%)和识别(50%)模型。然而,挑战包括缺乏进行依赖审查的指导方针以及资源限制,而获取评估报告是使用单边依赖模型的最常见障碍。结论:非洲许多当局采取了基于风险的药品注册方法,并创建了工作共享、单边依赖途径和区域化模式,以促进药品的可得性。权威人士认为,在未来,评估路线应该从独立的评估转向基于风险的模型。然而,这项研究表明,在实践中执行这一办法将面临挑战,其中包括改进资源能力和专家审稿人的人数以及实施电子跟踪系统。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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Evaluation of Risk-Based Approaches to the Registration of Medicines: Current Status Among African Regulatory Authorities.

Background: Despite the worldwide need for increased access to safe and effective medicines, there is a lack of innovative medicines in many low- to middle-income countries. On the African continent, this is partly due to capacity limitations of National Regulatory Authorities (NRAs). One important approach to address this issue is work sharing and regulatory reliance. Therefore, the aim of this study of regulatory authorities on the African continent was to identify which risk-based approaches are being used as well as their foreseen role in the future.

Methods: The study employed a questionnaire to identify which risk-based models are used for the regulatory approval of medicines and to determine which frameworks are in place to enable a risk-based approach, as well as to provide insight into the future direction for risk-based models. The questionnaire was sent electronically to 26 NRAs in the African Continent.

Results: Twenty-one authorities (80%) completed the questionnaire. Work sharing was the most commonly used model, followed closely by unilaterial reliance, information sharing, and collaborative review. These methods were perceived to be an effective and efficient use of resources, enabling faster medicine availability for patients. The unilateral reliance approach by the authorities included abridged (85%), verification (70%) and recognition (50%) models for a range of products. However, challenges included a lack of guidelines to undertake a reliance review together with resource constraints, while access to assessment reports was the most common barrier to using a unilateral reliance model.

Conclusions: Many authorities in Africa have adopted a risk-based approach to medicines registration and created work sharing, unilateral reliance pathways and regionalisation models to facilitate the availability of medicines. The authorities believe that in future, assessment routes should move from stand-alone reviews to risk-based models. However, this study indicated that there would be challenges to implement this approach in practice, which would include improving resource capacity and the number of expert reviewers as well as implementing electronic tracking systems.

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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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