Pharmaceuticals – Page 10
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JournalNavigating the regulatory landscape for regenerative medicines in Japan
This is the final article in a series of three that critically analyse the differences and similarities between the regulation of advanced therapy medicinal products (ATMPs), also known as regenerative medicines…[1],[2]
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FocusThe impact of the Northern Ireland Protocol on human medicines
Since the UK’s exit from the EU, the pharmaceutical industry has sought guidance on how this would impact the registration and supply of medicines, both in the UK and the EU. In addition, the publication of the Northern Ireland Protocol has added additional complexities, with a major impact on the ...
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FocusBrexit − Regulatory and supply chain considerations
The UK formally left the EU on 31 January 2020 and the transition period, as set out in the withdrawal agreement, came to an end on 31 December 2020. During this transition period, the UK continued to remain under EU pharmaceutical law. From 1 January 2021, the UK adopted an ...
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FocusPharmacovigilance regulations post-Brexit
The UK (Great Britain and Northern Ireland) has left the EU and the Brexit transition period has passed. This article covers points to consider when ensuring that pharmacovigilance systems for human medicinal products are compliant with EU and UK requirements. The UK requirements largely mirror the existing EU pharmacovigilance (PV) ...
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JournalSelection and justification of regulatory starting materials
A regulatory starting material (RSM) is the registered point at which drug substance manufacturing under good manufacturing practice (GMP) begins. RSMs are defined, isolated materials that are required to meet the general principles outlined in ICH Q11. This article provides guidance for small molecules in selecting and justifying starting materials from a risk-based perspective.
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FocusTime is running out for the rare pediatric disease designation and priority review voucher programs
Since 2012, the rare paediatric disease priority review voucher (RPD PRV) program in the US, provides incentives to promote research in leftover orphan paediatric disease...
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FocusConditional oncology drug approvals: A sponsor’s perspective on the evolving landscape of FDA accelerated approvals
The FDA’s accelerated approval (AA) pathway is an important regulatory mechanism that allows patients with serious or life-threatening conditions, potentially earlier access to treatments than under a standard, regular approval development pathway...
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JournalRequirements for the good distribution practice of medicinal products
No standardisation or formal educational framework to practice as a Responsible Person (RP) currently exists across EU countries. The current RP educational and work experience requirements in EU member states are discussed. (Note that the study was conducted before the UK left the EU, so it is included here among the EU member states.)
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FocusA regulatory lens on an industry imperative: Diversity in clinical research
Although clinical research is evolving alongside new technological advances, the inclusion of diverse populations within clinical trials has been slow. Regulatory professionals are essential stakeholders in the quest for ensuring inclusivity of these groups…
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JournalNonclinical immunogenicity evaluation in toxicology studies of biopharmaceuticals
One of the critical features that determines the clinical efficacy and safety of biotherapeutics, especially therapeutic proteins, is their ability to induce formation of antibodies against themselves. However, the clinical outcome cannot be predicted using the immunogenicity data from nonclinical studies…