All Journal articles – Page 7
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JournalAccess consortium: in the current submission transmission ecosystem
The Access Consortium is a medium-sized coalition of regulatory authorities that work together to promote greater collaboration and alignment of regulatory requirements. This union began in 2007 with the involvement of Australia, Canada, Singapore, and Switzerland, and was later in 2021 bolstered by the addition of the United Kingdom’s Medicines ...
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JournalMedical device standards update: November 2023
This edition of our regular column updates the progress of applicable standards to October 2023.
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JournalTransitioning from paper to electronic IFU for EU MDR 2017/745
The European Union Medical Device Regulation (EU MDR) Regulation (EU) 2017/745[1] amends current the EU Medical Device Directive (MDD) ‘93/42/EEC’ and the EU Active Implantable Medical Device (AIMD) ‘90/385/EEC’ directives. The regulation governs the manufacturing and supply of medical devices in the European Region and its territories. Several significant changes ...
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JournalA harmonised approach to clinical data standards
David Evans, President and CEO of Clinical Data Interchange Standards Consortium (CDISC), speaks to the journal’s November Issue Editor Leah Kleylein to discuss his role at the helm of the standards development organisation and the ways it is advancing global data standards in the clinical research realm.
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JournalPrequalification of veterinary vaccines and medicines
An initiative to assure the quality of veterinary medicinal products for use in animal health programmes to support humanitarian assistance.
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JournalTransition to the new QRD template for veterinary medicines: challenges and opportunities
The product information template version 9 (QRD v.9) supports the requirements of the Veterinary Medicinal Products Regulation (EU) 2019/6[1] (VMR), which has applied since 28 January 2022. Considering the high workload and costs associated with the quality review document (QRD) updates, the huge number of veterinary medicinal products (VMPs) concerned, ...
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JournalOptimal materials selection in medical device development – a proactive biocompatibility approach
Regulatory Rapporteur October 2023 | Volume 20 | No.9 Introduction Biocompatibility evaluation of medical devices is a complex task related to various factors that include mainly chemical nature and physical properties of the material, the ...
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JournalEMA activities related to antiparasitic veterinary medicinal products
Antiparasitic medicines rightly play an important role in veterinary medicine, as antiparasitic diseases can have important impacts on animal health and welfare and are economically significant. Antiparasitic veterinary medicinal products (VMPs) are evaluated under the same thorough licensing procedure as all other veterinary medicines before they are authorised, and are ...
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JournalAutogenous vaccines under Regulation (EU) 2019/6
Through Regulation (EU) 2019/6, it has been the first time that so-called autogenous vaccines (AVs) are included in the EU legislation that rules veterinary medicinal products. Described as inactivated vaccines which are manufactured from pathogens obtained from animals in an epidemiological unit, they are restricted to the ...
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JournalQ&A:
Navigating the
pharmaceutical supply chainMatthew Scripps, Director, Supply Chain Planning, Mundipharma interviewed by Vickie Goff, TOPRA Editorial Board member
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JournalRegulatory considerations of a growing pharmaceutical company: a UK/US comparison of the generics industry
Generics must demonstrate equivalence to the originator product to gain regulatory approval and market entry. There is a large market for generics that is predicted to continue to grow. The individual price of generics is lower than the originator, nevertheless manufacturers can avoid large development costs to bring generics to ...
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JournalNavigating the global supply of starting materials for cell-based therapies
The use of biological starting materials in the development of allogeneic cell-based therapies poses several challenges, whether due to availability of appropriate donors, complicated global logistics, or lack of global regulatory harmonisation around technical testing requirements. Sponsors must pay attention to adventitious agent safety requirements, which vary from region to region, and can also be affected by emerging disease threats, as was the case with the recent COVID-19 pandemic. Dr Elena Meurer, principal consultant and director at Biopharma Excellence, and Dr Jennifer Sales, consultant at Biopharma Excellence, explore these complexities.
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JournalBiosimilars CMC development considerations from the sponsor perspective
Sponsors face significant challenges in the development of biosimilars, particularly in the chemistry, manufacturing, and controls (CMC) aspects. Key areas of biosimilar CMC development include establishing a reliable and consistent manufacturing process, controlling critical quality attributes, and developing analytical methods to assess product quality. Furthermore, sponsors must conduct extensive characterisation studies, encompassing physicochemical and functional assays, to demonstrate biosimilarity between the biosimilar and the reference medicinal product (RMP). This article provides insights from a sponsor’s perspective, highlighting the challenges and opportunities associated with the biosimilar CMC development process. By adhering to these recommendations, sponsors can navigate the complexities of biosimilar development and enhance the likelihood of successful outcomes.
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JournalWarning letters for direct-to-consumer advertising: a five-year retrospective analysis
Background: Direct-to-consumer pharmaceutical advertising (DTCPA) is a ‘grey area’ that the Food and Drugs Administration (FDA) in the United States (US) regulates through the Centre for Drug Evaluation and Research (CDER). One of the purposes of DTCPA is to educate and empower patients via popular media such as television, radio, ...
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JournalEU versus Rest of the World regulatory frameworks and requirements for human tissue-based products
After participating in and/or hosting over 100 global competent authority inspections, the only true consistency is that no two inspections are the same. I see so many companies try to predict the inspectors approach, agenda…even the physical route they will take prior to the audit. Some upfront risk assessment and ...
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JournalA year of clinical trials under IVDR:
a sponsor’s perspectiveThe new EU in vitro diagnostic medical devices regulation (IVDR) extends to medical use of in vitro diagnostics (IVDs) in clinical trials, in addition to marketed IVDs. Although compliance to some aspects has been required since the Date of Application on 26 May 2022, there has been ...
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JournalRegulatory challenges and opportunities facing hearing aid manufacturers in Europe
In a world where many people are living longer but not all are living well and age-related hearing loss affects approximately 20% of the European population aged 65 or older – hearing aids address a medical need which for the most part remains unmet. With increasing evidence ...