An Industry Survey on Managing the Pharmacovigilance System Master File in a Global Environment: The Need for a Pragmatic Approach.

IF 3.1 Q2 PHARMACOLOGY & PHARMACY
Pharmaceutical Medicine Pub Date : 2022-08-01 Epub Date: 2022-06-20 DOI:10.1007/s40290-022-00422-2
Clare Lavery, Joanne Emmott, Sabine Jeck-Thole, Pascale Rouben, Dionne Usher, Willemijn van der Spuij, Louise Woodward
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引用次数: 0

Abstract

Background: Legislative requirements for Marketing Authorisation Holders (MAHs) to maintain a Pharmacovigilance System Master File (PSMF) were introduced in the European Union (EU) in 2010, operationalised in 2012 and subsequently introduced in other territories. There are no internationally agreed standards for the PSMF and country/regional requirements vary, leaving room for interpretation. This creates complexities for MAHs in implementing and maintaining multiple PSMFs.

Objectives: The approaches taken towards the creation and maintenance of PSMFs in a global environment were investigated using a survey in order to gain a better understanding of the impact of the PSMF for MAHs.

Methods: A structured benchmarking survey was conducted during September and October of 2019 and the responses were analysed. A questionnaire with open-ended questions was designed to elicit detailed information on PSMF management and provide insights into company experiences. Companies affiliated to the EU Federation of Pharmaceutical Industries and Associations (EFPIA) and industry stakeholders with experience of PSMFs were contacted ensuring a broad representation including small, medium and large pharmaceutical companies, contract organisations/consultants and research-driven and generic organisations.

Results: Thirty companies responded; of these, 29 provided information relating to their PSMF practices. Respondents acknowledged that the PSMF is a valuable document that has helped to create greater awareness of pharmacovigilance within companies. Complex and varying international requirements were recognised as burdensome, especially in the context of consistent development and maintenance of multiple PSMFs. The respondents indicated that companies use the EU PSMF to manage requirements in other territories. Similar areas for standardisation were identified across respondents.

Conclusion: The survey results highlight both the value of the PSMF and the challenges in maintaining it. Building on these responses, the paper offers pragmatic solutions to the challenges faced by MAHs and proposes a continued dialogue with key stakeholders in industry and national regulatory authorities about PSMF globalisation, harmonisation and simplification of requirements.

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关于在全球环境中管理药物警戒系统主文件的行业调查:采取务实方法的必要性。
背景:欧盟(EU)于 2010 年引入了上市许可持有人(MAHs)必须保存药物警戒系统主文件(PSMF)的立法要求,并于 2012 年开始实施,随后在其他地区也引入了这一要求。PSMF 没有国际公认的标准,各国/各地区的要求也各不相同,因此有解释的余地。这就给 MAHs 实施和维护多个 PSMF.Objectives 带来了复杂性:目的:通过一项调查,研究了在全球环境下创建和维护 PSMF 的方法,以便更好地了解 PSMF 对大型医疗卫生机构的影响:在 2019 年 9 月和 10 月期间进行了一次结构化基准调查,并对答复进行了分析。设计了一份包含开放式问题的调查问卷,以获得 PSMF 管理的详细信息,并深入了解公司的经验。我们联系了欧盟制药工业和协会联合会(EFPIA)的下属公司以及具有 PSMF 经验的行业利益相关者,确保其具有广泛的代表性,包括大中小型制药公司、合同组织/顾问以及研究驱动型和非专利组织:结果:30 家公司做出了回应;其中 29 家公司提供了有关其 PSMF 实践的信息。受访者认为 PSMF 是一份有价值的文件,有助于提高公司内部的药物警戒意识。复杂多样的国际要求被认为是一种负担,特别是在持续制定和维护多个 PSMF 的情况下。受访者表示,公司使用欧盟 PSMF 来管理其他地区的要求。所有受访者都指出了类似的标准化领域:调查结果凸显了 PSMF 的价值以及维护 PSMF 所面临的挑战。在这些答复的基础上,本文针对 MAH 面临的挑战提出了务实的解决方案,并建议与行业内的主要利益相关者和国家监管机构就 PSMF 的全球化、协调和简化要求继续开展对话。
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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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