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Framework to enable re-use of patient clinical data
A patient-centric legal framework intends to return clinical trial data to study participants, ready for re-use in further research or healthcare practice.
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European Federation of Pharmaceutical Industries and Associations (EFPIA)
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Is TEE the key for novel antibiotics?
Research suggests a Transferable Exclusivity Extension (TEE) system is “the only existing option capable of incentivising antibiotic R&D in a sustainable manner” for Europe.
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2022 spells change for EU pharmaceutical legislation
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…
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Big Pharma shares substance data to decrease animal testing
Four Big Pharma companies have shared previously unpublished hazard data for drug substances to enhance database-dependent computational tools and help reduce animal testing.
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Recommendations published on medicine procurement across the EU
The EFPIA has published 10 recommendations to ensure that procurement practices across the EU are effective and sustainable, delivering high quality medicines for patients, in the right quantities and at the right time.
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Ways to promote patient access as a European healthcare priority
We are experiencing a time of polarity in our healthcare systems with breakthrough treatment options developed, but access prohibited. Here, Catherine Owen, SVP of Major Markets at Bristol Myers Squibb, explains why, despite continued COVID-19 pressures, the time is ripe to rectify this situation.
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Less than lifetime limits for N-nitrosamine mutagenic impurities
Here, Dave Elder discusses the determination of less than lifetime (LTL) limits for highly potent N-nitrosamine compounds and how to ensure safety in dosing.
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EFPIA calls for harmonisation of GMO procedures in investigational drugs
The European Federation of Pharmaceutical Industries will implement a new regulation to co-ordinate genetically modified organism procedures.
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New EFPIA network created to combat cardiovascular diseases
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has initiated the CVD Network to improve policies for patients.
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Has the threat of waiving COVID-19 vaccine intellectual property rights had its desired effect?
In this final article on the TRIPS waiver for COVID-19 vaccines, medicines, diagnostics and technologies, EPR’s Hannah Balfour considers whether it is the correct strategy to overcome COVID-19 treatment inequalities and explores other options.
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Collaboration working to promote health research, development and innovation
A strategic European health research and innovation agenda is being compiled by five industry associations and the European Commission.
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Biopharma industry commits to working with regulatory agencies on COVID-19 vaccines
A statement from biopharmaceutical industry groups has said they plan to work with regulatory agencies to gather data on COVID-19 vaccines.
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Failure to secure ‘bare minimum’ deal on medicines could put patients at risk, MPs told
1 October 2020 | By
UK politicians were warned that without a post-Brexit deal on medicines, short-term supply delays could be damaging to both public health and the economy.
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UK and EU pharma call for medicines to be prioritised in Brexit trade talks
The ABPI and EFPIA have both emphasised the need for trade talks to mitigate medicine supply chain disruptions following Brexit.
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WHO launches Access to COVID-19 Tools Accelerator
The World Health Organization (WHO) has launched its Access to COVID-19 Tools Accelerator, a collaboration to progress the development of coronavirus vaccines and therapeutics.
