The Common Standard for electronic product information (ePI) is intended to improve delivery of information to patients and healthcare providers.
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European Union (EU)
How will a new regulatory landscape impact the EU and UK pharma industries? Early 2022 will see major new clinical trial legislation come into effect, with proposals for an entirely new regulatory regime promised by the end of the year. Paul Ranson, Consultant at Morgan Lewis, reflects on this and…
The regulation sees tools, structures and processes set up by EMA during the pandemic to accelerate clinical trial approval and regulatory assessments in the EU being formally recognised.
In this article, Sarah Bly and Aman Khera of Worldwide Clinical Trials break down the seven key differences between the EU Clinical Trial Directive and new EU Clinical Trial Regulation, discussing when and how sponsors should begin submitting their trials through the new CTIS portal system.
Killian O’Driscoll, Director of Projects at the National Institute for Bioprocessing Research and Training (NIBRT), highlights the plight of a future skills shortage in the global biopharma industry as state-of-the-art therapy production evolves at a rapid pace.
18 November 2021 | By
The agreement enables the EU and European Economic Area (EEA) countries to donate Moderna's COVID-19 vaccine to low-income countries.
Nathalie Moll, Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA) gives her take on the industry response to the pandemic; highlighting the benefits of focused effort and what can be achieved through unified collaboration.
The COVID-19 pandemic spotlighted drug repurposing as a key strategy to support traditional novel chemical entity development; yet repurposing is just one example of how off-patent molecules can be further developed to provide patients with more treatment options. Here, Arun Narayan, Chairman of the Value Added Medicines Sector Group at…
David Vincent, Process Development Lead at eXmoor Pharma, details some of the critical steps that form the manufacturing strategy for providers of cell and gene therapies.
In this interview, Adrian van den Hoven, Director General of Medicines for Europe, discusses all things supply of generic and biosimilar medicines for the continent. Also, in a bonus video, Adrian discusses challenges disrupting access to biosimilars and generics in Europe.
Pharmacovigilance obligations present significant challenges for biotechs. Small companies face the same rigor as large pharma - and it does not help that there is divergence between the requirements of the FDA, the EU and its member states. Here, seasoned pharmacovigilance experts and non-executive advisors to Arriello, Eric Caugant in…
The new recommendations, developed in the context of the COVID-19 pandemic, are designed to help countries and other stakeholders forecast demand of medicines in future pandemics.
Jasper Bovenberg and colleagues argue that the General Data Protection Regulation (GDPR) and associated guidelines has frustrated COVID-19 research, potentially harming global pandemic response efforts.
Advanced therapy medicinal products (ATMPs) are medicines based on genes, tissues or cells. They offer revolutionary opportunities for the treatment of disease and injury; however, developers face a complex regulatory and developmental landscape to bring ATMPs to market. Here Magdalena Czarnecka offers guidance and advice on effectively initiating an ATMP…