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.
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.