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In a reversal of approach, EU medicines regulators have for the first time published a statement supporting the interchangeability of biosimilar medicines in the EU. Here, Marie Manley and Chris Boyle from Sidley Austin LLP explore what this could mean for biopharma companies.
A new health technology regulation is due to be applied to help EU countries determine the effectiveness of novel technologies and decide on pricing and reimbursement by health insurers or health systems. Here, Professor Vincenzo Salvatore and Giuseppe Ragucci from BonelliErede reflect on what this means for the UK and…
In this article, Andrew Toher, Head of Customer Insights Europe at Enel X, delves into the potential benefits and key considerations of a sustainable energy strategy.
Europe launches the EU Non-communicable diseases (NCDs) initiative, while GSK and Novartis promise millions to support drug R&D for neglected tropical diseases and malaria.
With almost every aspect of pharmaceutical regulation currently under review across Europe and the proposal for changes expected in December 2022, in this article, Maarten Meulenbelt, Partner at Sidley Austin LLP, discusses with European Pharmaceutical Review some of the more controversial amendments under consideration and emphasises why industry participation is…
Pharma industry calls for support as restrictive pricing measures and rising costs of goods/inflation could undermine the availability of medicines.
The EU’s identification of medicinal products (IDMP) standards implementation was all set to go ahead, when the EMA suddenly announced a change of plan. The DADI user interface will now enable structured data submissions for the EMA PMS, at least for the near future. Drawing on recent dialogue with the…
The Common Standard for electronic product information (ePI) is intended to improve delivery of information to patients and healthcare providers.
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…
