Pharmaceutical News and Updates
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Changes in timelines with Scientific Advice Procedure
As of 17 November 2014, the European Medicines Agency is introducing changes to the procedures for scientific advice, parallel advice with health technology assessment (HTA) bodies, protocol assistance and qualification of novel methodologies. These…
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More on Adaptive Licensing (AL)
There is currently much debate about adaptive pathways for new medicinal products to come to the market. The terms ’staggered approval’, ’progressive licensing’, and ’adaptive licensing’ have been used, often interchangeably, to describe the…
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Adaptive Licensing
A Brief Summary of the new fast-track European procedure by Simon Ruini, Director of PhD London The Adaptive Licensing Pilot Project was launched by the EMA on 19 March 2014. This summary addresses some frequently asked…
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Regulatory information – Companies now required to update, complete and improve quality of information on authorised medicines
From today, the European Medicines Agency requires marketing-authorisation holders to update the information on authorised medicines that they have submitted in accordance with Article 57(2) of the 2010 pharmacovigilance legislation. This includes completing previously…
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Monitoring of Patent Settlements in Europe
Patent settlement agreements are commercial agreements to settle patent-related disputes, e.g. questions of patent infringement or patent validity. They are concluded in the context of patent disputes, opposition procedures or litigation where no final…
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End of Herbal Sell-through Period
The Medicines and Healthcare products Regulatory Agency (MHRA) is reminding herbal companies and retailers that, as of 1st May 2014, unlicensed manufactured herbal medicines without a traditional herbal registration (THR) or product licence (PL)…
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The 10 leading causes of death in the world (2014 update)
WHO has just published an interesting update to the leading causes of death. We pesent it in this article with some tables for ease of reading. The 10 leading causes of death in the…
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EMA and FDA meet on new initiatives
Senior leadership from DG Health and Consumers (European Commission), the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) discussed a number of key initiatives at a bilateral meeting which…
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Orphan Drugs and Ultra-orphan, NICE tries to find a balance.
Earlier this month the UK Bio-Industry Association published a report detailing their recommendations for the new ultra-orphan medicines evaluation framework for ultra-orphan drugs currently being developed by the UK’s Nation Institute for Health and Care…
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Orphan Products Approvals in Europe
A total of 11 out of 81 medicines recommended for marketing authorisation by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in 2013 were intended for the treatment of…